- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT06931340
Testa tillsatsen av docetaxel (kemoterapi) till den vanliga behandlingen (hormonbehandling och apalutamid) för metastaserande prostatacancer, Aspire -studie
Docetaxel-tillägg i metastaserande kastatkänslig prostatacancer (Aspire)
This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
PRIMARY OBJECTIVE:
I. To determine if the addition of docetaxel to androgen deprivation therapy and apalutamide improves overall survival for men with metastatic castrate sensitive prostate cancer.
SECONDARY OBJECTIVES:
I. To determine if the addition of docetaxel to androgen deprivation therapy and apalutamide improves overall survival for men whose cancers have loss or inactivating mutations of TP53, PTEN, or RB1.
II. To determine if the addition of docetaxel to ADT plus apalutamide improves the time to radiographic progression per Prostate Cancer Working Group 3 (PCWG3) guidelines.
III. To determine the time to castration-resistant prostate cancer (CRPC) between arms.
IV. To determine symptomatic skeletal event free survival (SSE-FS) between arms.
V. To determine the safety and tolerability of the triplet versus doublet using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
VI. To determine radiographic progression free survival (rPFS), and overall survival (OS) in patients by the stratification factors a) volume/timing of disease (metachronous high volume, synchronous high volume, and synchronous low volume metastases on conventional imaging) and b) tumor suppressor gene alteration status (0 versus [vs] 1 vs 2+) between arms.
VII. To determine prostate specific antigen (PSA) 90 response rate at 6 weeks and 6 months between arms.
VIII. To determine time to PSA progression by PCWG3 criteria between arms. IX. To determine objective response rate (ORR) in patients with measurable disease between arms.
EXPLORATORY OBJECTIVES:
I. To determine the time to worsening of physical symptoms of disease based on functional assessment of cancer therapy/National Comprehensive Cancer Network prostate cancer symptom index 17 item questionnaire (NCCN-FACT FPSI-17) between arms.
II. To compare quality of life as measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) trial outcome index in patients with metastatic castrate-sensitive prostate cancer (mCSPC) who receive ADT + apalutamide + docetaxel vs ADT + apalutamide at the 24-month time point.
III. To compare quality of life as measured by other scales of the FACT-P in the two arms.
IV. To compare quality of life as measured by FACT-P total outcome index in the two arms at other timepoints.
V. To compare pain severity and interference as measured by the Brief Pain Inventory Short Form (BPI-SF) in the two arms.
VI. To compare quality-adjusted life years which accounts for survival and utility (measured by European Quality of Life Five Dimension Five Level Scale [EQ-5D-5L]) in the two arms.
VII. To correlate baseline volume of disease on prostate-specific membrane antigen-positron emission tomography/computed tomography (PSMA-PET/CT) with baseline volume of disease on conventional imaging (CI).
VIII. To determine if baseline PSMA-PET/CT and CI are individually and jointly associated with OS, progression-free survival (PFS), PSA90 response, and PSA < 0.2 ng/ml after 6 months, and to estimate its clinical relevance when compared to these well characterized prognostic endpoints.
IX. To correlate 6-month PSA level with the presence/absence and volume of residual disease on PSMA-PET/CT after 6 months of doublet or triplet therapy.
X. To correlate the concordance of radiographic progression on CI versus PSMA-PET/CT at the time of PSA progression.
XI. To determine rPFS, time to castration resistance, OS based on thresholds of volume of disease, and prostate-specific membrane antigen (PSMA) uptake (standardized uptake value [SUV]) based on baseline PSMA-PET/CT scan.
XII. To compare rPFS, time to castration resistance, and OS between arms in patients with de novo metastatic disease having received primary directed radiation therapy.
XIII. To determine rPFS, time to castration resistance, and OS correlation with PSA response at 6 weeks and 6 months.
XIV. To compare the impact of treatment on aging trajectory, as measured by the change in Deficit-Accumulation Frailty Index (DAFI) from baseline, 6- and 12-months, in the two arms.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive ADT at the discretion of the investigator and apalutamide orally (PO) once daily (QD). Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) and bone scan throughout the study. Patients may optionally undergo prostate-specific membrane antigen-positron emission tomography (PSMA-PET) scans and blood sample collection throughout the study.
ARM 2: Patients receive ADT at the discretion of the investigator and apalutamide PO QD. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive docetaxel intravenously (IV) over 1 hour every 21 days for up to 6 doses. Additionally, patients undergo CT scan or MRI and bone scan throughout the study. Patients may optionally undergo PSMA-PET scans and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 6 months for up to 10 years.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Shiva Baghaie, MPH
- Telefonnummer: (773) 702-9171
- E-post: GUprotocols@alliancenctn.org
Studieorter
-
-
Arizona
-
Tucson, Arizona, Förenta staterna, 85719
- Rekrytering
- Banner University Medical Center - Tucson
-
Kontakt:
- Site Public Contact
- E-post: UACC-IIT@uacc.arizona.edu
-
Huvudutredare:
- Edward P. Gelmann
-
Tucson, Arizona, Förenta staterna, 85719
- Rekrytering
- University of Arizona Cancer Center-North Campus
-
Kontakt:
- Site Public Contact
- E-post: UACC-IIT@uacc.arizona.edu
-
Huvudutredare:
- Edward P. Gelmann
-
-
California
-
Dublin, California, Förenta staterna, 94568
- Rekrytering
- Kaiser Permanente Dublin
-
Huvudutredare:
- Andrea L. Harzstark
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-642-4691
-
Fremont, California, Förenta staterna, 94538
- Rekrytering
- Kaiser Permanente-Fremont
-
Huvudutredare:
- Andrea L. Harzstark
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-642-4691
- E-post: Kpoct@kp.org
-
Fresno, California, Förenta staterna, 93720
- Rekrytering
- Kaiser Permanente Fresno Orchard Plaza
-
Huvudutredare:
- Andrea L. Harzstark
-
Kontakt:
- Site Public Contact
- Telefonnummer: 833-574-2273
-
La Jolla, California, Förenta staterna, 92093
- Rekrytering
- UC San Diego Moores Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 858-822-5354
- E-post: cancercto@ucsd.edu
-
Huvudutredare:
- Yu-Wei Chen
-
Modesto, California, Förenta staterna, 95356
- Rekrytering
- Kaiser Permanente-Modesto
-
Huvudutredare:
- Andrea L. Harzstark
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-642-4691
- E-post: Kpoct@kp.org
-
Modesto, California, Förenta staterna, 95356
- Rekrytering
- Kaiser Permanente- Modesto MOB II
-
Huvudutredare:
- Andrea L. Harzstark
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-642-4691
-
Oakland, California, Förenta staterna, 94611
- Rekrytering
- Kaiser Permanente-Oakland
-
Huvudutredare:
- Andrea L. Harzstark
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-642-4691
- E-post: Kpoct@kp.org
-
Rancho Mirage, California, Förenta staterna, 92270
- Rekrytering
- Eisenhower Medical Center
-
Huvudutredare:
- Delshad Ahmad
-
Kontakt:
- Site Public Contact
- Telefonnummer: 760-834-3798
-
Roseville, California, Förenta staterna, 95661
- Rekrytering
- Kaiser Permanente-Roseville
-
Huvudutredare:
- Andrea L. Harzstark
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-642-4691
- E-post: Kpoct@kp.org
-
Sacramento, California, Förenta staterna, 95814
- Rekrytering
- Kaiser Permanente Downtown Commons
-
Huvudutredare:
- Andrea L. Harzstark
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-642-4691
- E-post: kpoct@kp.org
-
Sacramento, California, Förenta staterna, 95823
- Rekrytering
- Kaiser Permanente-South Sacramento
-
Huvudutredare:
- Andrea L. Harzstark
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-642-4691
- E-post: Kpoct@kp.org
-
San Diego, California, Förenta staterna, 92103
- Rekrytering
- UC San Diego Medical Center - Hillcrest
-
Kontakt:
- Site Public Contact
- E-post: rhabbaba@health.ucsd.edu
-
Huvudutredare:
- Yu-Wei Chen
-
San Francisco, California, Förenta staterna, 94115
- Rekrytering
- Kaiser Permanente-San Francisco
-
Huvudutredare:
- Andrea L. Harzstark
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-642-4691
- E-post: Kpoct@kp.org
-
San Jose, California, Förenta staterna, 95119
- Rekrytering
- Kaiser Permanente-Santa Teresa-San Jose
-
Huvudutredare:
- Andrea L. Harzstark
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-642-4691
- E-post: Kpoct@kp.org
-
San Leandro, California, Förenta staterna, 94577
- Rekrytering
- Kaiser Permanente San Leandro
-
Huvudutredare:
- Andrea L. Harzstark
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-642-4691
- E-post: Kpoct@kp.org
-
San Rafael, California, Förenta staterna, 94903
- Rekrytering
- Kaiser San Rafael-Gallinas
-
Huvudutredare:
- Andrea L. Harzstark
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-642-4691
- E-post: Kpoct@kp.org
-
Santa Clara, California, Förenta staterna, 95051
- Rekrytering
- Kaiser Permanente Medical Center - Santa Clara
-
Huvudutredare:
- Andrea L. Harzstark
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-642-4691
- E-post: Kpoct@kp.org
-
Santa Rosa, California, Förenta staterna, 95403
- Rekrytering
- Kaiser Permanente-Santa Rosa
-
Huvudutredare:
- Andrea L. Harzstark
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-642-4691
- E-post: Kpoct@kp.org
-
South San Francisco, California, Förenta staterna, 94080
- Rekrytering
- Kaiser Permanente-South San Francisco
-
Huvudutredare:
- Andrea L. Harzstark
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-642-4691
- E-post: Kpoct@kp.org
-
Vallejo, California, Förenta staterna, 94589
- Rekrytering
- Kaiser Permanente-Vallejo
-
Huvudutredare:
- Andrea L. Harzstark
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-642-4691
- E-post: Kpoct@kp.org
-
Walnut Creek, California, Förenta staterna, 94596
- Rekrytering
- Kaiser Permanente-Walnut Creek
-
Huvudutredare:
- Andrea L. Harzstark
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-642-4691
- E-post: Kpoct@kp.org
-
-
Colorado
-
Aurora, Colorado, Förenta staterna, 80045
- Rekrytering
- Rocky Mountain Regional VA Medical Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 888-336-8262
-
Huvudutredare:
- Jessica D. McDermott
-
Denver, Colorado, Förenta staterna, 80205
- Rekrytering
- Kaiser Permanente-Franklin
-
Huvudutredare:
- Matthew J. Eadens
-
Kontakt:
- Site Public Contact
- Telefonnummer: 303-817-9295
- E-post: KPCOIHRClinicalResearch@kp.org
-
Edwards, Colorado, Förenta staterna, 81632
- Rekrytering
- Shaw Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 970-569-7429
-
Huvudutredare:
- Erin Schwab
-
Grand Junction, Colorado, Förenta staterna, 81501
- Rekrytering
- Saint Mary's Hospital and Regional Medical Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 303-777-2663
- E-post: ccrp@co-cancerresearch.org
-
Huvudutredare:
- Wallace Jones
-
Lafayette, Colorado, Förenta staterna, 80026
- Rekrytering
- Kaiser Permanente-Rock Creek
-
Huvudutredare:
- Matthew J. Eadens
-
Kontakt:
- Site Public Contact
- Telefonnummer: 303-817-9295
- E-post: KPCOIHRClinicalResearch@kp.org
-
Lone Tree, Colorado, Förenta staterna, 80124
- Rekrytering
- Kaiser Permanente-Lone Tree
-
Huvudutredare:
- Matthew J. Eadens
-
Kontakt:
- Site Public Contact
- Telefonnummer: 303-817-9295
- E-post: KPCOIHRClinicalResearch@kp.org
-
-
Delaware
-
Dover, Delaware, Förenta staterna, 19901
- Aktiv, inte rekryterande
- Bayhealth Hospital Kent Campus
-
Milford, Delaware, Förenta staterna, 19963
- Aktiv, inte rekryterande
- Bayhealth Hospital Sussex Campus
-
-
District of Columbia
-
Washington D.C., District of Columbia, Förenta staterna, 20007
- Rekrytering
- MedStar Georgetown University Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 202-444-2223
-
Huvudutredare:
- Suthee Rapisuwon
-
Washington D.C., District of Columbia, Förenta staterna, 20010
- Rekrytering
- MedStar Washington Hospital Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 202-877-8839
-
Huvudutredare:
- Suthee Rapisuwon
-
-
Florida
-
Gainesville, Florida, Förenta staterna, 32610
- Rekrytering
- Malcom Randall Veterans Administration Medical Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 352-273-8675
- E-post: trials@cancer.ufl.edu
-
Huvudutredare:
- Jess DeLaune
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna, 30342
- Rekrytering
- Northside Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 404-303-3355
- E-post: ClinicalTrials@northside.com
-
Huvudutredare:
- Shailesh R. Satpute
-
Duluth, Georgia, Förenta staterna, 30096
- Rekrytering
- Northside Hospital - Duluth
-
Kontakt:
- Site Public Contact
- Telefonnummer: 404-303-3355
- E-post: Clinical.trials@northside.com
-
Huvudutredare:
- Shailesh R. Satpute
-
Lawrenceville, Georgia, Förenta staterna, 30046
- Rekrytering
- Northside Hospital - Gwinnett
-
Kontakt:
- Site Public Contact
- Telefonnummer: 404-303-3355
- E-post: Clinical.trials@northside.com
-
Huvudutredare:
- Shailesh R. Satpute
-
-
Hawaii
-
Honolulu, Hawaii, Förenta staterna, 96819
- Rekrytering
- Kaiser Permanente Moanalua Medical Center
-
Huvudutredare:
- Andrea L. Harzstark
-
Kontakt:
- Site Public Contact
- Telefonnummer: 808-432-5195
- E-post: shelley.a.clark@kp.org
-
-
Idaho
-
Boise, Idaho, Förenta staterna, 83712
- Rekrytering
- Saint Luke's Cancer Institute - Boise
-
Huvudutredare:
- Alison K. Conlin
-
Kontakt:
- Site Public Contact
- Telefonnummer: 208-381-2774
- E-post: eslinget@slhs.org
-
Coeur d'Alene, Idaho, Förenta staterna, 83814
- Rekrytering
- Kootenai Health - Coeur d'Alene
-
Huvudutredare:
- John M. Schallenkamp
-
Kontakt:
- Site Public Contact
- Telefonnummer: 406-969-6060
- E-post: mccinfo@mtcancer.org
-
Fruitland, Idaho, Förenta staterna, 83619
- Rekrytering
- Saint Luke's Cancer Institute - Fruitland
-
Huvudutredare:
- Alison K. Conlin
-
Kontakt:
- Site Public Contact
- Telefonnummer: 208-381-2774
- E-post: eslinget@slhs.org
-
Meridian, Idaho, Förenta staterna, 83642
- Rekrytering
- Saint Luke's Cancer Institute - Meridian
-
Huvudutredare:
- Alison K. Conlin
-
Kontakt:
- Site Public Contact
- Telefonnummer: 208-381-2774
- E-post: eslinget@slhs.org
-
Nampa, Idaho, Förenta staterna, 83687
- Rekrytering
- Saint Luke's Cancer Institute - Nampa
-
Huvudutredare:
- Alison K. Conlin
-
Kontakt:
- Site Public Contact
- Telefonnummer: 208-381-2774
- E-post: eslinget@slhs.org
-
Post Falls, Idaho, Förenta staterna, 83854
- Rekrytering
- Kootenai Clinic Cancer Services - Post Falls
-
Huvudutredare:
- John M. Schallenkamp
-
Kontakt:
- Site Public Contact
- Telefonnummer: 406-969-6060
- E-post: mccinfo@mtcancer.org
-
Sandpoint, Idaho, Förenta staterna, 83864
- Rekrytering
- Kootenai Clinic Cancer Services - Sandpoint
-
Huvudutredare:
- John M. Schallenkamp
-
Kontakt:
- Site Public Contact
- Telefonnummer: 406-969-6060
- E-post: mccinfo@mtcancer.org
-
-
Illinois
-
Bloomington, Illinois, Förenta staterna, 61704
- Rekrytering
- Illinois CancerCare-Bloomington
-
Kontakt:
- Site Public Contact
- Telefonnummer: 309-243-3605
- E-post: andersonj@illinoiscancercare.com
-
Huvudutredare:
- Bryan A. Faller
-
Canton, Illinois, Förenta staterna, 61520
- Rekrytering
- Illinois CancerCare-Canton
-
Kontakt:
- Site Public Contact
- Telefonnummer: 309-243-3605
- E-post: andersonj@illinoiscancercare.com
-
Huvudutredare:
- Bryan A. Faller
-
Carthage, Illinois, Förenta staterna, 62321
- Rekrytering
- Illinois CancerCare-Carthage
-
Kontakt:
- Site Public Contact
- Telefonnummer: 309-243-3605
- E-post: andersonj@illinoiscancercare.com
-
Huvudutredare:
- Bryan A. Faller
-
Centralia, Illinois, Förenta staterna, 62801
- Rekrytering
- Centralia Oncology Clinic
-
Huvudutredare:
- Bryan A. Faller
-
Kontakt:
- Site Public Contact
- Telefonnummer: 217-876-4762
- E-post: morganthaler.jodi@mhsil.com
-
Chicago, Illinois, Förenta staterna, 60612
- Rekrytering
- University of Illinois
-
Kontakt:
- Site Public Contact
- Telefonnummer: 312-355-3046
-
Huvudutredare:
- Karine Tawagi
-
Chicago, Illinois, Förenta staterna, 60612
- Rekrytering
- Rush MD Anderson Cancer Center
-
Huvudutredare:
- Manan Shah
-
Kontakt:
- Site Public Contact
- Telefonnummer: 312-226-2371
- E-post: Cancer_Studies@rush.edu
-
Danville, Illinois, Förenta staterna, 61832
- Rekrytering
- Carle at The Riverfront
-
Huvudutredare:
- Kendrith M. Rowland
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-446-5532
- E-post: Research@Carle.com
-
Decatur, Illinois, Förenta staterna, 62526
- Rekrytering
- Cancer Care Specialists of Illinois - Decatur
-
Huvudutredare:
- Bryan A. Faller
-
Kontakt:
- Site Public Contact
- Telefonnummer: 217-876-4762
- E-post: morganthaler.jodi@mhsil.com
-
Decatur, Illinois, Förenta staterna, 62526
- Rekrytering
- Decatur Memorial Hospital
-
Huvudutredare:
- Bryan A. Faller
-
Kontakt:
- Site Public Contact
- Telefonnummer: 217-876-4762
- E-post: morganthaler.jodi@mhsil.com
-
Dixon, Illinois, Förenta staterna, 61021
- Rekrytering
- Illinois CancerCare-Dixon
-
Huvudutredare:
- Bryan A. Faller
-
Kontakt:
- Site Public Contact
- Telefonnummer: 815-285-7800
-
Effingham, Illinois, Förenta staterna, 62401
- Rekrytering
- Carle Physician Group-Effingham
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-446-5532
- E-post: Research@carle.com
-
Huvudutredare:
- Kendrith M. Rowland
-
Effingham, Illinois, Förenta staterna, 62401
- Rekrytering
- Crossroads Cancer Center
-
Huvudutredare:
- Bryan A. Faller
-
Kontakt:
- Site Public Contact
- Telefonnummer: 217-876-4762
- E-post: morganthaler.jodi@mhsil.com
-
Eureka, Illinois, Förenta staterna, 61530
- Rekrytering
- Illinois CancerCare-Eureka
-
Kontakt:
- Site Public Contact
- Telefonnummer: 309-243-3605
- E-post: andersonj@illinoiscancercare.com
-
Huvudutredare:
- Bryan A. Faller
-
Galesburg, Illinois, Förenta staterna, 61401
- Rekrytering
- Illinois CancerCare-Galesburg
-
Kontakt:
- Site Public Contact
- Telefonnummer: 309-243-3605
- E-post: andersonj@illinoiscancercare.com
-
Huvudutredare:
- Bryan A. Faller
-
Hines, Illinois, Förenta staterna, 60141
- Rekrytering
- Edward Hines Jr VA Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 708-202-8387
-
Huvudutredare:
- Elizabeth Henry
-
Kewanee, Illinois, Förenta staterna, 61443
- Rekrytering
- Illinois CancerCare-Kewanee Clinic
-
Kontakt:
- Site Public Contact
- Telefonnummer: 309-243-3605
- E-post: andersonj@illinoiscancercare.com
-
Huvudutredare:
- Bryan A. Faller
-
Macomb, Illinois, Förenta staterna, 61455
- Rekrytering
- Illinois CancerCare-Macomb
-
Kontakt:
- Site Public Contact
- Telefonnummer: 309-243-3605
- E-post: andersonj@illinoiscancercare.com
-
Huvudutredare:
- Bryan A. Faller
-
Mattoon, Illinois, Förenta staterna, 61938
- Rekrytering
- Carle Physician Group-Mattoon/Charleston
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-446-5532
- E-post: Research@carle.com
-
Huvudutredare:
- Kendrith M. Rowland
-
Mount Vernon, Illinois, Förenta staterna, 62864
- Rekrytering
- SSM Health Good Samaritan
-
Huvudutredare:
- Jay W. Carlson
-
Kontakt:
- Site Public Contact
- Telefonnummer: 618-899-1894
- E-post: gayla.hall@ssmhealth.com
-
Normal, Illinois, Förenta staterna, 61761
- Rekrytering
- Carle BroMenn Medical Center
-
Huvudutredare:
- Kendrith M. Rowland
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-446-5532
- E-post: Research@Carle.com
-
Normal, Illinois, Förenta staterna, 61761
- Rekrytering
- Carle Cancer Institute Normal
-
Huvudutredare:
- Kendrith M. Rowland
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-446-5532
- E-post: Research@Carle.com
-
O'Fallon, Illinois, Förenta staterna, 62269
- Rekrytering
- Cancer Care Center of O'Fallon
-
Huvudutredare:
- Bryan A. Faller
-
Kontakt:
- Site Public Contact
- Telefonnummer: 217-876-4762
- E-post: morganthaler.jodi@mhsil.com
-
O'Fallon, Illinois, Förenta staterna, 62269
- Rekrytering
- HSHS Saint Elizabeth's Hospital
-
Huvudutredare:
- Bryan A. Faller
-
Kontakt:
- Site Public Contact
- Telefonnummer: 217-876-4762
- E-post: morganthaler.jodi@mhsil.com
-
Ottawa, Illinois, Förenta staterna, 61350
- Rekrytering
- Illinois CancerCare-Ottawa Clinic
-
Kontakt:
- Site Public Contact
- Telefonnummer: 309-243-3605
- E-post: andersonj@illinoiscancercare.com
-
Huvudutredare:
- Bryan A. Faller
-
Pekin, Illinois, Förenta staterna, 61554
- Rekrytering
- Illinois CancerCare-Pekin
-
Kontakt:
- Site Public Contact
- Telefonnummer: 309-243-3605
- E-post: andersonj@illinoiscancercare.com
-
Huvudutredare:
- Bryan A. Faller
-
Peoria, Illinois, Förenta staterna, 61615
- Rekrytering
- Illinois CancerCare-Peoria
-
Kontakt:
- Site Public Contact
- Telefonnummer: 309-243-3605
- E-post: andersonj@illinoiscancercare.com
-
Huvudutredare:
- Bryan A. Faller
-
Peru, Illinois, Förenta staterna, 61354
- Rekrytering
- Illinois CancerCare-Peru
-
Kontakt:
- Site Public Contact
- Telefonnummer: 309-243-3605
- E-post: andersonj@illinoiscancercare.com
-
Huvudutredare:
- Bryan A. Faller
-
Princeton, Illinois, Förenta staterna, 61356
- Rekrytering
- Illinois CancerCare-Princeton
-
Kontakt:
- Site Public Contact
- Telefonnummer: 309-243-3605
- E-post: andersonj@illinoiscancercare.com
-
Huvudutredare:
- Bryan A. Faller
-
Shiloh, Illinois, Förenta staterna, 62269
- Rekrytering
- Memorial Hospital East
-
Kontakt:
- Site Public Contact
- Telefonnummer: 314-747-9912
- E-post: dschwab@wustl.edu
-
Huvudutredare:
- Eric M. Knoche
-
Springfield, Illinois, Förenta staterna, 62702
- Rekrytering
- Southern Illinois University School of Medicine
-
Huvudutredare:
- Bryan A. Faller
-
Kontakt:
- Site Public Contact
- Telefonnummer: 217-545-7929
-
Springfield, Illinois, Förenta staterna, 62702
- Rekrytering
- Springfield Clinic
-
Huvudutredare:
- Bryan A. Faller
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-444-7541
-
Springfield, Illinois, Förenta staterna, 62781
- Rekrytering
- Springfield Memorial Hospital
-
Huvudutredare:
- Bryan A. Faller
-
Kontakt:
- Site Public Contact
- Telefonnummer: 217-528-7541
- E-post: pallante.beth@mhsil.com
-
Urbana, Illinois, Förenta staterna, 61801
- Rekrytering
- Carle Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-446-5532
- E-post: Research@carle.com
-
Huvudutredare:
- Kendrith M. Rowland
-
Washington, Illinois, Förenta staterna, 61571
- Rekrytering
- Illinois CancerCare - Washington
-
Kontakt:
- Site Public Contact
- Telefonnummer: 309-243-3605
- E-post: andersonj@illinoiscancercare.com
-
Huvudutredare:
- Bryan A. Faller
-
-
Iowa
-
Ames, Iowa, Förenta staterna, 50010
- Rekrytering
- Mary Greeley Medical Center
-
Huvudutredare:
- Joseph J. Merchant
-
Kontakt:
- Site Public Contact
- Telefonnummer: 515-956-4132
-
Ames, Iowa, Förenta staterna, 50010
- Rekrytering
- McFarland Clinic - Ames
-
Huvudutredare:
- Joseph J. Merchant
-
Kontakt:
- Site Public Contact
- Telefonnummer: 515-239-4734
- E-post: ksoder@mcfarlandclinic.com
-
Boone, Iowa, Förenta staterna, 50036
- Upphängd
- McFarland Clinic - Boone
-
Cedar Rapids, Iowa, Förenta staterna, 52403
- Rekrytering
- Mercy Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 319-365-4673
-
Huvudutredare:
- Deborah W. Wilbur
-
Cedar Rapids, Iowa, Förenta staterna, 52403
- Rekrytering
- Oncology Associates at Mercy Medical Center
-
Huvudutredare:
- Deborah W. Wilbur
-
Kontakt:
- Site Public Contact
- Telefonnummer: 319-363-2690
-
Fort Dodge, Iowa, Förenta staterna, 50501
- Rekrytering
- McFarland Clinic - Trinity Cancer Center
-
Huvudutredare:
- Joseph J. Merchant
-
Kontakt:
- Site Public Contact
- Telefonnummer: 515-956-4132
-
Jefferson, Iowa, Förenta staterna, 50129
- Upphängd
- McFarland Clinic - Jefferson
-
Marshalltown, Iowa, Förenta staterna, 50158
- Rekrytering
- McFarland Clinic - Marshalltown
-
Huvudutredare:
- Joseph J. Merchant
-
Kontakt:
- Site Public Contact
- Telefonnummer: 515-956-4132
-
-
Kansas
-
Hays, Kansas, Förenta staterna, 67601
- Rekrytering
- HaysMed
-
Kontakt:
- Site Public Contact
- Telefonnummer: 785-623-5774
-
Huvudutredare:
- Elizabeth M. Wulff
-
Lawrence, Kansas, Förenta staterna, 66044
- Rekrytering
- Lawrence Memorial Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 785-505-2800
- E-post: Stephanie.Norris@LMH.ORG
-
Huvudutredare:
- Elizabeth M. Wulff
-
Olathe, Kansas, Förenta staterna, 66061
- Rekrytering
- The University of Kansas Cancer Center - Olathe
-
Kontakt:
- Site Public Contact
- Telefonnummer: 913-588-1569
- E-post: OlatheCCResearch@kumc.edu
-
Huvudutredare:
- Elizabeth M. Wulff
-
Overland Park, Kansas, Förenta staterna, 66210
- Rekrytering
- University of Kansas Cancer Center-Overland Park
-
Kontakt:
- Site Public Contact
- Telefonnummer: 913-588-3671
- E-post: KUCC_Navigation@kumc.edu
-
Huvudutredare:
- Elizabeth M. Wulff
-
Salina, Kansas, Förenta staterna, 67401
- Rekrytering
- Salina Regional Health Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 785-452-7038
- E-post: mleepers@srhc.com
-
Huvudutredare:
- Elizabeth M. Wulff
-
Topeka, Kansas, Förenta staterna, 66606
- Rekrytering
- University of Kansas Health System Saint Francis Campus
-
Kontakt:
- Site Public Contact
- Telefonnummer: 785-295-8000
-
Huvudutredare:
- Elizabeth M. Wulff
-
Westwood, Kansas, Förenta staterna, 66205
- Rekrytering
- University of Kansas Hospital-Westwood Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 913-588-3671
- E-post: KUCC_Navigation@kumc.edu
-
Huvudutredare:
- Elizabeth M. Wulff
-
-
Michigan
-
Brighton, Michigan, Förenta staterna, 48114
- Rekrytering
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
-
Kontakt:
- Site Public Contact
- Telefonnummer: 734-712-7251
- E-post: MCRCwebsitecontactform@stjoeshealth.org
-
Huvudutredare:
- Christopher M. Reynolds
-
Canton, Michigan, Förenta staterna, 48188
- Rekrytering
- Trinity Health IHA Medical Group Hematology Oncology - Canton
-
Kontakt:
- Site Public Contact
- Telefonnummer: 734-712-7251
- E-post: MCRCwebsitecontactform@stjoeshealth.org
-
Huvudutredare:
- Christopher M. Reynolds
-
Chelsea, Michigan, Förenta staterna, 48118
- Rekrytering
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 734-712-7251
- E-post: MCRCwebsitecontactform@stjoeshealth.org
-
Huvudutredare:
- Christopher M. Reynolds
-
Escanaba, Michigan, Förenta staterna, 49829
- Rekrytering
- OSF Saint Francis Hospital and Medical Group
-
Huvudutredare:
- Anthony J. Jaslowski
-
Kontakt:
- Site Public Contact
- Telefonnummer: 920-433-8889
- E-post: WI_research_admin@hshs.org
-
Flint, Michigan, Förenta staterna, 48503
- Rekrytering
- Genesys Hurley Cancer Institute
-
Huvudutredare:
- Christopher M. Reynolds
-
Kontakt:
- Site Public Contact
- Telefonnummer: 810-762-8038
- E-post: wstrong@ghci.org
-
Flint, Michigan, Förenta staterna, 48503
- Rekrytering
- Hurley Medical Center
-
Huvudutredare:
- Christopher M. Reynolds
-
Kontakt:
- Site Public Contact
- Telefonnummer: 810-762-8038
- E-post: wstrong@ghci.org
-
Flint, Michigan, Förenta staterna, 48503
- Rekrytering
- Cancer Hematology Centers - Flint
-
Huvudutredare:
- Christopher M. Reynolds
-
Kontakt:
- Site Public Contact
- Telefonnummer: 810-762-8038
- E-post: wstrong@ghci.org
-
Lansing, Michigan, Förenta staterna, 48912
- Rekrytering
- University of Michigan Health - Sparrow Lansing
-
Huvudutredare:
- Christopher M. Reynolds
-
Kontakt:
- Site Public Contact
- Telefonnummer: 517-364-3712
- E-post: harsha.trivedi@umhsparrow.org
-
Livonia, Michigan, Förenta staterna, 48154
- Rekrytering
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 734-712-7251
- E-post: MCRCwebsitecontactform@stjoeshealth.org
-
Huvudutredare:
- Christopher M. Reynolds
-
Pontiac, Michigan, Förenta staterna, 48341
- Rekrytering
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 734-712-7251
- E-post: MCRCwebsitecontactform@stjoeshealth.org
-
Huvudutredare:
- Christopher M. Reynolds
-
Ypsilanti, Michigan, Förenta staterna, 48197
- Rekrytering
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
-
Kontakt:
- Site Public Contact
- Telefonnummer: 734-712-7251
- E-post: MCRCwebsitecontactform@stjoeshealth.org
-
Huvudutredare:
- Christopher M. Reynolds
-
-
Minnesota
-
Bemidji, Minnesota, Förenta staterna, 56601
- Rekrytering
- Sanford Joe Lueken Cancer Center
-
Huvudutredare:
- Daniel Almquist
-
Kontakt:
- Site Public Contact
- Telefonnummer: 218-333-5000
- E-post: OncologyClinicalTrialsFargo@sanfordhealth.org
-
Saint Cloud, Minnesota, Förenta staterna, 56303
- Rekrytering
- Coborn Cancer Center at Saint Cloud Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-229-4907
- E-post: coborncancercenter@centracare.com
-
Huvudutredare:
- Donald J. Jurgens
-
-
Missouri
-
Cape Girardeau, Missouri, Förenta staterna, 63703
- Rekrytering
- Saint Francis Medical Center
-
Huvudutredare:
- Bryan A. Faller
-
Kontakt:
- Site Public Contact
- Telefonnummer: 573-334-2230
- E-post: sfmc@sfmc.net
-
City of Saint Peters, Missouri, Förenta staterna, 63376
- Rekrytering
- Siteman Cancer Center at Saint Peters Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-600-3606
- E-post: info@siteman.wustl.edu
-
Huvudutredare:
- Eric M. Knoche
-
Creve Coeur, Missouri, Förenta staterna, 63141
- Rekrytering
- Siteman Cancer Center at West County Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-600-3606
- E-post: info@siteman.wustl.edu
-
Huvudutredare:
- Eric M. Knoche
-
Kansas City, Missouri, Förenta staterna, 64154
- Rekrytering
- University of Kansas Cancer Center - North
-
Kontakt:
- Site Public Contact
- Telefonnummer: 913-588-3671
- E-post: KUCC_Navigation@kumc.edu
-
Huvudutredare:
- Elizabeth M. Wulff
-
Kansas City, Missouri, Förenta staterna, 64108
- Rekrytering
- University Health Truman Medical Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 816-404-4375
-
Huvudutredare:
- Elizabeth M. Wulff
-
Kansas City, Missouri, Förenta staterna, 64116
- Rekrytering
- University of Kansas Cancer Center - Briarcliff
-
Huvudutredare:
- Elizabeth M. Wulff
-
Kontakt:
- Site Public Contact
- Telefonnummer: 913-588-3671
-
Lee's Summit, Missouri, Förenta staterna, 64064
- Rekrytering
- University of Kansas Cancer Center - Lee's Summit
-
Kontakt:
- Site Public Contact
- Telefonnummer: 913-588-3671
- E-post: KUCC_Navigation@kumc.edu
-
Huvudutredare:
- Elizabeth M. Wulff
-
St Louis, Missouri, Förenta staterna, 63110
- Rekrytering
- Washington University School of Medicine
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-600-3606
- E-post: info@siteman.wustl.edu
-
Huvudutredare:
- Eric M. Knoche
-
St Louis, Missouri, Förenta staterna, 63128
- Rekrytering
- Mercy Hospital South
-
Huvudutredare:
- Jay W. Carlson
-
Kontakt:
- Site Public Contact
- Telefonnummer: 314-525-6042
- E-post: Danielle.Werle@mercy.net
-
St Louis, Missouri, Förenta staterna, 63141
- Rekrytering
- Mercy Hospital Saint Louis
-
Huvudutredare:
- Jay W. Carlson
-
Kontakt:
- Site Public Contact
- Telefonnummer: 314-251-7066
-
St Louis, Missouri, Förenta staterna, 63129
- Rekrytering
- Siteman Cancer Center-South County
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-600-3606
- E-post: info@siteman.wustl.edu
-
Huvudutredare:
- Eric M. Knoche
-
St Louis, Missouri, Förenta staterna, 63136
- Rekrytering
- Siteman Cancer Center at Christian Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-600-3606
- E-post: info@siteman.wustl.edu
-
Huvudutredare:
- Eric M. Knoche
-
St Louis, Missouri, Förenta staterna, 63125
- Rekrytering
- Veteran's Affairs Medical Center - Saint Louis
-
Kontakt:
- Site Public Contact
- Telefonnummer: 773-702-9171
- E-post: protocols@AllianceNCTN.org
-
Huvudutredare:
- Eric M. Knoche
-
-
Montana
-
Anaconda, Montana, Förenta staterna, 59711
- Rekrytering
- Community Hospital of Anaconda
-
Huvudutredare:
- John M. Schallenkamp
-
Kontakt:
- Site Public Contact
- Telefonnummer: 406-969-6060
- E-post: mccinfo@mtcancer.org
-
Billings, Montana, Förenta staterna, 59101
- Rekrytering
- Billings Clinic Cancer Center
-
Huvudutredare:
- John M. Schallenkamp
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-996-2663
- E-post: research@billingsclinic.org
-
Billings, Montana, Förenta staterna, 59102
- Rekrytering
- Saint Vincent Frontier Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-648-6274
-
Huvudutredare:
- Wallace Jones
-
Bozeman, Montana, Förenta staterna, 59715
- Rekrytering
- Bozeman Health Deaconess Hospital
-
Huvudutredare:
- John M. Schallenkamp
-
Kontakt:
- Site Public Contact
- Telefonnummer: 406-969-6060
- E-post: mccinfo@mtcancer.org
-
Great Falls, Montana, Förenta staterna, 59405
- Rekrytering
- Benefis Sletten Cancer Institute
-
Huvudutredare:
- John M. Schallenkamp
-
Kontakt:
- Site Public Contact
- Telefonnummer: 406-969-6060
- E-post: mccinfo@mtcancer.org
-
Kalispell, Montana, Förenta staterna, 59901
- Rekrytering
- Logan Health Medical Center
-
Huvudutredare:
- John M. Schallenkamp
-
Kontakt:
- Site Public Contact
- Telefonnummer: 406-969-6060
- E-post: mccinfo@mtcancer.org
-
Missoula, Montana, Förenta staterna, 59804
- Rekrytering
- Community Medical Center
-
Huvudutredare:
- John M. Schallenkamp
-
Kontakt:
- Site Public Contact
- Telefonnummer: 406-969-6060
- E-post: mccinfo@mtcancer.org
-
-
New Jersey
-
Basking Ridge, New Jersey, Förenta staterna, 07920
- Rekrytering
- Memorial Sloan Kettering Basking Ridge
-
Kontakt:
- Site Public Contact
- Telefonnummer: 212-639-7592
-
Huvudutredare:
- Kristine P. Lacuna
-
Cherry Hill, New Jersey, Förenta staterna, 08002
- Rekrytering
- Jefferson Cherry Hill Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 215-600-9151
- E-post: ONCTrialNow@jefferson.edu
-
Huvudutredare:
- Kevin K. Zarrabi
-
Middletown, New Jersey, Förenta staterna, 07748
- Rekrytering
- Memorial Sloan Kettering Monmouth
-
Kontakt:
- Site Public Contact
- Telefonnummer: 212-639-7592
-
Huvudutredare:
- Kristine P. Lacuna
-
Montvale, New Jersey, Förenta staterna, 07645
- Rekrytering
- Memorial Sloan Kettering Bergen
-
Kontakt:
- Site Public Contact
- Telefonnummer: 212-639-7592
-
Huvudutredare:
- Kristine P. Lacuna
-
Sewell, New Jersey, Förenta staterna, 08080
- Rekrytering
- Sidney Kimmel Cancer Center Washington Township
-
Kontakt:
- Site Public Contact
- Telefonnummer: 215-600-9151
- E-post: ONCTrialNow@jefferson.edu
-
Huvudutredare:
- Kevin K. Zarrabi
-
-
New York
-
Buffalo, New York, Förenta staterna, 14263
- Rekrytering
- Roswell Park Cancer Institute
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-767-9355
- E-post: askroswell@roswellpark.org
-
Huvudutredare:
- Ellis G. Levine
-
Commack, New York, Förenta staterna, 11725
- Rekrytering
- Memorial Sloan Kettering Commack
-
Kontakt:
- Site Public Contact
- Telefonnummer: 212-639-7592
-
Huvudutredare:
- Kristine P. Lacuna
-
Cortland, New York, Förenta staterna, 13045
- Rekrytering
- Guthrie Cortland Memorial Hospital
-
Huvudutredare:
- Alina Basnet
-
Kontakt:
- Site Public Contact
- Telefonnummer: 607-756-3130
-
Harrison, New York, Förenta staterna, 10604
- Rekrytering
- Memorial Sloan Kettering Westchester
-
Kontakt:
- Site Public Contact
- Telefonnummer: 212-639-7592
-
Huvudutredare:
- Kristine P. Lacuna
-
New York, New York, Förenta staterna, 10065
- Rekrytering
- Memorial Sloan Kettering Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 212-639-7592
-
Huvudutredare:
- Kristine P. Lacuna
-
New York, New York, Förenta staterna, 10029
- Rekrytering
- Mount Sinai Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 212-824-7309
- E-post: CCTO@mssm.edu
-
Huvudutredare:
- Eric J. Miller
-
Stony Brook, New York, Förenta staterna, 11794
- Rekrytering
- Stony Brook University Medical Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-862-2215
-
Huvudutredare:
- Judy Huang
-
Uniondale, New York, Förenta staterna, 11553
- Rekrytering
- Memorial Sloan Kettering Nassau
-
Kontakt:
- Site Public Contact
- Telefonnummer: 212-639-7592
-
Huvudutredare:
- Kristine P. Lacuna
-
-
North Carolina
-
Durham, North Carolina, Förenta staterna, 27710
- Rekrytering
- Duke University Medical Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 888-275-3853
-
Huvudutredare:
- Hannah D. McManus
-
Durham, North Carolina, Förenta staterna, 27705
- Rekrytering
- Durham VA Medical Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 919-286-0411
- E-post: VHADURcancertrials@va.gov
-
Huvudutredare:
- Rhonda L. Bitting
-
Pinehurst, North Carolina, Förenta staterna, 28374
- Rekrytering
- FirstHealth of the Carolinas-Moore Regional Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 910-715-3500
- E-post: jcwilliams@firsthealth.org
-
Huvudutredare:
- Charles S. Kuzma
-
-
North Dakota
-
Bismarck, North Dakota, Förenta staterna, 58501
- Rekrytering
- Sanford Bismarck Medical Center
-
Huvudutredare:
- Daniel Almquist
-
Kontakt:
- Site Public Contact
- Telefonnummer: 701-323-5760
- E-post: OncologyClinicalTrialsFargo@sanfordhealth.org
-
Fargo, North Dakota, Förenta staterna, 58122
- Rekrytering
- Sanford Broadway Medical Center
-
Huvudutredare:
- Daniel Almquist
-
Kontakt:
- Site Public Contact
- Telefonnummer: 701-323-5760
- E-post: OncologyClinicalTrialsFargo@sanfordhealth.org
-
Fargo, North Dakota, Förenta staterna, 58122
- Rekrytering
- Sanford Roger Maris Cancer Center
-
Huvudutredare:
- Daniel Almquist
-
Kontakt:
- Site Public Contact
- Telefonnummer: 701-234-6161
- E-post: OncologyClinicalTrialsFargo@sanfordhealth.org
-
-
Ohio
-
Canton, Ohio, Förenta staterna, 44710
- Rekrytering
- Aultman Health Foundation
-
Kontakt:
- Site Public Contact
- Telefonnummer: 330-363-7274
- E-post: ClinicalReserachDept@aultman.com
-
Huvudutredare:
- Mehool A. Patel
-
Columbus, Ohio, Förenta staterna, 43210
- Rekrytering
- Ohio State University Comprehensive Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-293-5066
- E-post: Jamesline@osumc.edu
-
Huvudutredare:
- Lingbin Meng
-
Sylvania, Ohio, Förenta staterna, 43560
- Rekrytering
- ProMedica Flower Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 419-824-1842
- E-post: PCIOncResearch@promedica.org
-
Huvudutredare:
- Jeffrey H. Muler
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Förenta staterna, 73104
- Rekrytering
- University of Oklahoma Health Sciences Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 405-271-8777
- E-post: ou-clinical-trials@ouhsc.edu
-
Huvudutredare:
- Adanma Anji Ayanambakkam Attanathi
-
-
Pennsylvania
-
Erie, Pennsylvania, Förenta staterna, 16544
- Rekrytering
- Saint Vincent Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 814-452-5000
-
Huvudutredare:
- Shifeng S. Mao
-
Jefferson Hills, Pennsylvania, Förenta staterna, 15025
- Rekrytering
- Jefferson Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 412-359-3043
- E-post: ddefazio@wpahs.org
-
Huvudutredare:
- Shifeng S. Mao
-
Monroeville, Pennsylvania, Förenta staterna, 15146
- Rekrytering
- Forbes Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 412-858-7746
-
Huvudutredare:
- Shifeng S. Mao
-
Natrona Heights, Pennsylvania, Förenta staterna, 15065
- Rekrytering
- Allegheny Valley Hospital
-
Kontakt:
- Site Public Contact
- E-post: Dawnmarie.DeFazio@ahn.org
-
Huvudutredare:
- Shifeng S. Mao
-
Philadelphia, Pennsylvania, Förenta staterna, 19107
- Rekrytering
- Thomas Jefferson University Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 215-600-9151
- E-post: ONCTrialNow@jefferson.edu
-
Huvudutredare:
- Kevin K. Zarrabi
-
Philadelphia, Pennsylvania, Förenta staterna, 19148
- Upphängd
- Jefferson Methodist Hospital
-
Philadelphia, Pennsylvania, Förenta staterna, 19114
- Rekrytering
- Jefferson Torresdale Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 215-600-9151
- E-post: ONCTrialNow@jefferson.edu
-
Huvudutredare:
- Kevin K. Zarrabi
-
Pittsburgh, Pennsylvania, Förenta staterna, 15224
- Rekrytering
- West Penn Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 412-578-5000
-
Huvudutredare:
- Shifeng S. Mao
-
Pittsburgh, Pennsylvania, Förenta staterna, 15212
- Rekrytering
- Allegheny General Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-284-2000
-
Huvudutredare:
- Shifeng S. Mao
-
Sayre, Pennsylvania, Förenta staterna, 18840
- Rekrytering
- Guthrie Medical Group PC-Robert Packer Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-836-0388
-
Huvudutredare:
- Joyson Poulose
-
Wexford, Pennsylvania, Förenta staterna, 15090
- Rekrytering
- Wexford Health and Wellness Pavilion
-
Kontakt:
- Site Public Contact
- E-post: Dawnmarie.DeFazio@ahn.org
-
Huvudutredare:
- Shifeng S. Mao
-
Willow Grove, Pennsylvania, Förenta staterna, 19090
- Rekrytering
- Asplundh Cancer Pavilion
-
Kontakt:
- Site Public Contact
- Telefonnummer: 215-600-9151
- E-post: ONCTrialNow@jefferson.edu
-
Huvudutredare:
- Kevin K. Zarrabi
-
-
South Carolina
-
Greenville, South Carolina, Förenta staterna, 29601
- Rekrytering
- Saint Francis Hospital
-
Huvudutredare:
- Stephen H. Dyar
-
Kontakt:
- Site Public Contact
- Telefonnummer: 864-603-6234
- E-post: Heather_Rich@bshsi.org
-
Greenville, South Carolina, Förenta staterna, 29607
- Rekrytering
- Saint Francis Cancer Center
-
Huvudutredare:
- Stephen H. Dyar
-
Kontakt:
- Site Public Contact
- Telefonnummer: 864-603-6234
- E-post: Heather_Rich@bshsi.org
-
Greenwood, South Carolina, Förenta staterna, 29646
- Rekrytering
- Self Regional Healthcare
-
Kontakt:
- Site Public Contact
- Telefonnummer: 864-725-4771
- E-post: nmcgaha@selfregional.org
-
Huvudutredare:
- Albert C. Lockhart
-
-
South Dakota
-
Rapid City, South Dakota, Förenta staterna, 57701
- Aktiv, inte rekryterande
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Förenta staterna, 57104
- Rekrytering
- Sanford Cancer Center Oncology Clinic
-
Huvudutredare:
- Daniel Almquist
-
Kontakt:
- Site Public Contact
- Telefonnummer: 605-312-3320
- E-post: OncologyClinicTrialsSF@sanfordhealth.org
-
Sioux Falls, South Dakota, Förenta staterna, 57117-5134
- Rekrytering
- Sanford USD Medical Center - Sioux Falls
-
Huvudutredare:
- Daniel Almquist
-
Kontakt:
- Site Public Contact
- Telefonnummer: 605-312-3320
- E-post: OncologyClinicalTrialsSF@SanfordHealth.org
-
-
Texas
-
Dallas, Texas, Förenta staterna, 75390
- Rekrytering
- UT Southwestern/Simmons Cancer Center-Dallas
-
Kontakt:
- Site Public Contact
- Telefonnummer: 214-648-7097
- E-post: canceranswerline@UTSouthwestern.edu
-
Huvudutredare:
- Qian Qin
-
Dallas, Texas, Förenta staterna, 75237
- Rekrytering
- UT Southwestern Simmons Cancer Center - RedBird
-
Huvudutredare:
- Qian Qin
-
Kontakt:
- Site Public Contact
- Telefonnummer: 214-648-7097
- E-post: canceranswerline@utsouthwestern.edu
-
Fort Worth, Texas, Förenta staterna, 76104
- Rekrytering
- UT Southwestern/Simmons Cancer Center-Fort Worth
-
Kontakt:
- Site Public Contact
- Telefonnummer: 214-648-7097
- E-post: canceranswerline@UTSouthwestern.edu
-
Huvudutredare:
- Qian Qin
-
Richardson, Texas, Förenta staterna, 75080
- Rekrytering
- UT Southwestern Clinical Center at Richardson/Plano
-
Kontakt:
- Site Public Contact
- Telefonnummer: 972-669-7044
- E-post: Suzanne.cole@utsouthwestern.edu
-
Huvudutredare:
- Qian Qin
-
-
Utah
-
Murray, Utah, Förenta staterna, 84107
- Rekrytering
- Intermountain Medical Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 801-507-3950
- E-post: officeofresearch@imail.org
-
Huvudutredare:
- Wallace Jones
-
Ogden, Utah, Förenta staterna, 84403
- Rekrytering
- McKay-Dee Hospital Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 801-387-7426
- E-post: officeofresearch@imail.org
-
Huvudutredare:
- Wallace Jones
-
Salt Lake City, Utah, Förenta staterna, 84143
- Rekrytering
- LDS Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 801-408-1347
- E-post: officeofresearch@imail.org
-
Huvudutredare:
- Wallace Jones
-
Sandy City, Utah, Förenta staterna, 84094
- Rekrytering
- Intermountain Health Alta View Hospital
-
Huvudutredare:
- Wallace Jones
-
Kontakt:
- Site Public Contact
- E-post: IntermountainResearch@imail.org
-
St. George, Utah, Förenta staterna, 84770
- Rekrytering
- Saint George Regional Medical Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 833-321-3332
- E-post: officeofresearch@imail.org
-
Huvudutredare:
- Wallace Jones
-
-
Vermont
-
Berlin Corners, Vermont, Förenta staterna, 05602
- Rekrytering
- Central Vermont Medical Center/National Life Cancer Treatment
-
Kontakt:
- Site Public Contact
- Telefonnummer: 802-225-5400
-
Huvudutredare:
- Rahul Anil
-
Burlington, Vermont, Förenta staterna, 05401
- Rekrytering
- University of Vermont Medical Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 802-656-4101
- E-post: rpo@uvm.edu
-
Huvudutredare:
- Rahul Anil
-
Burlington, Vermont, Förenta staterna, 05405
- Rekrytering
- University of Vermont and State Agricultural College
-
Kontakt:
- Site Public Contact
- Telefonnummer: 802-656-8990
- E-post: rpo@uvm.edu
-
Huvudutredare:
- Rahul Anil
-
-
Virginia
-
Fredericksburg, Virginia, Förenta staterna, 22408
- Rekrytering
- Hematology Oncology Associates of Fredericksburg Inc
-
Kontakt:
- Site Public Contact
- Telefonnummer: 540-371-0079
- E-post: cvaughn@hoafredericksburg.com
-
Huvudutredare:
- Asit K. Paul
-
Richmond, Virginia, Förenta staterna, 23235
- Rekrytering
- VCU Massey Cancer Center at Stony Point
-
Kontakt:
- Site Public Contact
- E-post: ctoclinops@vcu.edu
-
Huvudutredare:
- Asit K. Paul
-
Richmond, Virginia, Förenta staterna, 23298
- Rekrytering
- VCU Massey Comprehensive Cancer Center
-
Huvudutredare:
- Asit K. Paul
-
Kontakt:
- Site Public Contact
- Telefonnummer: 804-628-6430
- E-post: CTOclinops@vcu.edu
-
Tappahannock, Virginia, Förenta staterna, 22560
- Rekrytering
- VCU Health Tappahannock Hospital
-
Huvudutredare:
- Asit K. Paul
-
Kontakt:
- Site Public Contact
- E-post: klcampbell@vcu.edu
-
-
West Virginia
-
Charleston, West Virginia, Förenta staterna, 25304
- Rekrytering
- Vandalia Health/CAMC Institute for Academic Medicine
-
Huvudutredare:
- Kok Hoe Chan
-
Kontakt:
- Site Public Contact
- Telefonnummer: 304-388-9944
- E-post: CAMCClinicalTrials@vandaliahealth.org
-
-
Wisconsin
-
Antigo, Wisconsin, Förenta staterna, 54409
- Rekrytering
- Aspirus Cancer Care-Antigo-Volm Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 715-623-9869
- E-post: Juli.Alford@aspirus.org
-
Huvudutredare:
- Andrew J. Huang
-
Appleton, Wisconsin, Förenta staterna, 54911
- Rekrytering
- ThedaCare Regional Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 920-364-3604
- E-post: ResearchDept@thedacare.org
-
Huvudutredare:
- Joyce Philip
-
Appleton, Wisconsin, Förenta staterna, 54915
- Rekrytering
- Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
-
Huvudutredare:
- Kamal Kant Singh Abbi
-
Kontakt:
- Site Public Contact
- E-post: AWRI.inquiry@ascension.org
-
Brookfield, Wisconsin, Förenta staterna, 53045
- Rekrytering
- Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield
-
Huvudutredare:
- Kamal Kant Singh Abbi
-
Kontakt:
- Site Public Contact
- E-post: AWRI.Inquiry@Ascension.org
-
Chilton, Wisconsin, Förenta staterna, 53014
- Rekrytering
- Ascension Calumet Hospital-Chilton
-
Huvudutredare:
- Kamal Kant Singh Abbi
-
Kontakt:
- Site Public Contact
- E-post: AWRI.inquiry@ascension.org
-
Franklin, Wisconsin, Förenta staterna, 53132
- Rekrytering
- Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson
-
Huvudutredare:
- Kamal Kant Singh Abbi
-
Kontakt:
- Site Public Contact
- E-post: AWRI.Inquiry@Ascension.org
-
Green Bay, Wisconsin, Förenta staterna, 54301
- Rekrytering
- Saint Vincent Hospital Cancer Center Green Bay
-
Huvudutredare:
- Anthony J. Jaslowski
-
Kontakt:
- Site Public Contact
- Telefonnummer: 920-433-8889
- E-post: WI_research_admin@hshs.org
-
Green Bay, Wisconsin, Förenta staterna, 54303
- Rekrytering
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
Huvudutredare:
- Anthony J. Jaslowski
-
Kontakt:
- Site Public Contact
- Telefonnummer: 920-433-8889
- E-post: wi_research_admin@hshs.org
-
Madison, Wisconsin, Förenta staterna, 53705
- Rekrytering
- William S Middleton VA Medical Center
-
Huvudutredare:
- David Kosoff
-
Kontakt:
- Site Public Contact
- Telefonnummer: 17007 608-256-1901
-
Medford, Wisconsin, Förenta staterna, 54451
- Rekrytering
- Aspirus Medford Hospital
-
Huvudutredare:
- Andrew J. Huang
-
Kontakt:
- Site Public Contact
- Telefonnummer: 715-847-2353
- E-post: Beth.Knetter@aspirus.org
-
Menomonee Falls, Wisconsin, Förenta staterna, 53051
- Rekrytering
- Froedtert Menomonee Falls Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 262-257-5100
-
Huvudutredare:
- Deepak Kilari
-
Mequon, Wisconsin, Förenta staterna, 53097
- Rekrytering
- Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon
-
Huvudutredare:
- Kamal Kant Singh Abbi
-
Kontakt:
- Site Public Contact
- E-post: AWRI.Inquiry@Ascension.org
-
Milwaukee, Wisconsin, Förenta staterna, 53226
- Rekrytering
- Medical College of Wisconsin
-
Kontakt:
- Site Public Contact
- Telefonnummer: 414-805-3666
-
Huvudutredare:
- Deepak Kilari
-
Milwaukee, Wisconsin, Förenta staterna, 53295
- Rekrytering
- Zablocki Veterans Administration Medical Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 888-469-6614
-
Huvudutredare:
- Sumana Devata
-
Milwaukee, Wisconsin, Förenta staterna, 53211
- Rekrytering
- Ascension Columbia Saint Mary's Hospital-Milwaukee Campus
-
Huvudutredare:
- Kamal Kant Singh Abbi
-
Kontakt:
- Site Public Contact
- E-post: AWRI.Inquiry@Ascension.org
-
New Berlin, Wisconsin, Förenta staterna, 53151
- Rekrytering
- Froedtert and MCW Moorland Reserve Health Center
-
Huvudutredare:
- Deepak Kilari
-
Kontakt:
- Site Public Contact
- Telefonnummer: 414-805-0505
-
Oak Creek, Wisconsin, Förenta staterna, 53154
- Rekrytering
- Drexel Town Square Health Center
-
Huvudutredare:
- Deepak Kilari
-
Kontakt:
- Site Public Contact
- Telefonnummer: 414-805-0505
-
Oconto Falls, Wisconsin, Förenta staterna, 54154
- Rekrytering
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Huvudutredare:
- Anthony J. Jaslowski
-
Kontakt:
- Site Public Contact
- Telefonnummer: 920-433-8889
- E-post: WI_research_admin@hshs.org
-
Oshkosh, Wisconsin, Förenta staterna, 54904
- Rekrytering
- Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh
-
Huvudutredare:
- Kamal Kant Singh Abbi
-
Kontakt:
- Site Public Contact
- E-post: AWRI.inquiry@ascension.org
-
Racine, Wisconsin, Förenta staterna, 53405
- Rekrytering
- Ascension All Saints Hospital-Spring Street-Racine
-
Huvudutredare:
- Kamal Kant Singh Abbi
-
Kontakt:
- Site Public Contact
- E-post: AWRI.Inquiry@Ascension.org
-
Rhinelander, Wisconsin, Förenta staterna, 54501
- Rekrytering
- Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
-
Huvudutredare:
- Andrew J. Huang
-
Kontakt:
- Site Public Contact
- Telefonnummer: 715-847-2353
- E-post: Beth.Knetter@aspirus.org
-
Sheboygan, Wisconsin, Förenta staterna, 53081
- Rekrytering
- Saint Vincent Hospital Cancer Center at Sheboygan
-
Huvudutredare:
- Anthony J. Jaslowski
-
Kontakt:
- Site Public Contact
- Telefonnummer: 920-433-8889
- E-post: wi_research_admin@hshs.org
-
Sheboygan, Wisconsin, Förenta staterna, 53081
- Rekrytering
- Sheboygan Physicians Group
-
Huvudutredare:
- Anthony J. Jaslowski
-
Kontakt:
- Site Public Contact
- Telefonnummer: 920-433-8889
- E-post: wi_research_admin@hshs.org
-
Stevens Point, Wisconsin, Förenta staterna, 54481
- Rekrytering
- Aspirus Cancer Care - Stevens Point
-
Huvudutredare:
- Andrew J. Huang
-
Kontakt:
- Site Public Contact
- Telefonnummer: 715-847-2353
- E-post: Beth.Knetter@aspirus.org
-
Sturgeon Bay, Wisconsin, Förenta staterna, 54235-1495
- Rekrytering
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
-
Huvudutredare:
- Anthony J. Jaslowski
-
Kontakt:
- Site Public Contact
- Telefonnummer: 920-433-8889
- E-post: wi_research_admin@hshs.org
-
Wausau, Wisconsin, Förenta staterna, 54401
- Rekrytering
- Aspirus Cancer Care-Wausau
-
Huvudutredare:
- Andrew J. Huang
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-405-6866
-
Wauwatosa, Wisconsin, Förenta staterna, 53226
- Rekrytering
- Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa
-
Huvudutredare:
- Kamal Kant Singh Abbi
-
Kontakt:
- Site Public Contact
- E-post: AWRI.Inquiry@Ascension.org
-
West Bend, Wisconsin, Förenta staterna, 53095
- Rekrytering
- Froedtert West Bend Hospital/Kraemer Cancer Center
-
Huvudutredare:
- Deepak Kilari
-
Kontakt:
- Site Public Contact
- Telefonnummer: 414-805-0505
-
Wisconsin Rapids, Wisconsin, Förenta staterna, 54494
- Rekrytering
- Aspirus Cancer Care - Wisconsin Rapids
-
Huvudutredare:
- Andrew J. Huang
-
Kontakt:
- Site Public Contact
- Telefonnummer: 715-422-7718
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
-
Documentation of disease:
* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
-
Must have had evidence of metastatic disease (American Joint Committee on Cancer [AJCC] metastasis [M]1 disease) based on conventional CT/MRI and/or bone scan. This will be defined as:
- Bone metastases detected by CT, radionuclide technetium-99 (99Tc)- methylene bisphosphonate bone scan, or MRI as defined by PCWG3 criteria; OR
- Non-pelvic lymph node metastases (measurable lymph nodes above the aortic bifurcation; lymph nodes are measurable if the short axis diameter is ≥ 15 mm) detected on CT or MRI as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Subjects with regional lymph node metastases only (nodes [N]1, below the aortic bifurcation) will not be eligible for the study; OR
- Visceral or soft tissue metastases detected on CT or MRI as defined by RECIST version 1.1. Soft tissue/visceral lesions are measurable if the long axis diameter is ≥ 10 mm
- Evidence of metastatic disease by PSMA-PET only and not visible by CT, radionuclide bone scan, or MRI will not satisfy eligibility criteria
-
No metachronous low-volume disease (defined as recurrent metastatic disease after definitive treatment of prostate primary) and with ≤ 4 bone metastasis and no visceral metastasis on conventional imaging by CT, radionuclide 99Tc-biphosphonate bone scan, or MRI)
-
Next generation sequencing (NGS) results from any tissue based Clinical Laboratory Improvement Act (CLIA) test must be available at the time of registration. NGS from soft tissue or visceral lesion if available is preferred. NGS from bone or primary prostate will be accepted. Patients with failed NGS testing are not eligible
-
Prior treatment
- ADT (luteinizing hormone-releasing hormone [LHRH] agonist/antagonist or orchiectomy) with or without first generation anti-androgen, or second-generation androgen receptor signaling inhibitor (ARSI) within 120 days of registration is permitted. No washout period will be needed for the first generation- androgen or ARSI prior to registration. Anti-androgen treatment is only permitted if used within 120 days of registration
- No prior chemotherapy for prostate cancer
-
Age ≥ 18 years
-
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
-
Absolute neutrophil count (ANC) ≥ 1,500/mm^3
-
Hemoglobin ≥ 9.0 g/dL
-
Platelet count ≥ 100,000/mm^3
-
Total bilirubin ≤ 1 x upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1 × ULN, subject may be eligible)
-
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate transaminase [SGT]) ≤ 1.5 x upper limit of normal (ULN)
-
Calculated (Calc.) creatinine clearance > 30 mL/min
-
Serum potassium ≥ 3.5 mmol/L
-
Comorbid conditions
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Leptomeningeal metastases: Patients with treated leptomeningeal metastases are eligible if follow-up brain imaging 30 days after central nervous system (CNS)-directed therapy shows no evidence of progression
- HIV: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
- Hepatitis B: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Hepatitis C: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- No seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation or condition requiring CNS surgery or radiation therapy)
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class II or better. Any condition that in the opinion of the investigator, would preclude participation in this study. Patients with stable asymptomatic deep venous thromboembolism on stable anti-coagulation will be eligible
- Hypertension: Subjects with uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) >= 160 mmHg or diastolic BP >= 100 mmHg despite medical management are not permitted to register
- Allergies: Subjects with known hypersensitivity to any of the study drugs, or excipients in the formulation of the study drugs are not permitted to register
-
Concomitant medications
- Chronic concomitant treatment with strong inhibitors of cytochrome P450 3A4 (CYP3A4) is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug prior to registration on the study. See Section 8.1.9 for more information
- Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
- Medications known to lower the seizure threshold must be discontinued or substituted prior to study entry. See Section 8.1.9 for more information
-
Patient agrees to use a condom (even men with vasectomies) and another effective method of birth control if having sex with a woman of childbearing potential or agrees to use a condom if having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Arm 1 (ADT, apalutamide)
Patients receive ADT at the discretion of the investigator and apalutamide PO QD. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scan or MRI and bone scan throughout the study. Patients may optionally undergo PSMA-PET scans and blood sample collection throughout the study. |
Undergo blood sample collection Undergo CT
Andra namn:
Undergo MRI
Andra namn:
Given PO Undergo Bone Scan Undergo PSMA PET Scan Given ADT undergo Questionnaire Administration |
|
Experimentell: Arm 2 (ADT, apalutamide, docetaxel)
Patients receive ADT at the discretion of the investigator and apalutamide PO QD. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive docetaxel IV over 1 hour every 21 days for up to 6 doses. Additionally, patients undergo CT scan or MRI and bone scan throughout the study. Patients may optionally undergo PSMA-PET scans and blood sample collection throughout the study. |
Given IV
Andra namn:
Undergo blood sample collection Undergo CT
Andra namn:
Undergo MRI
Andra namn:
Given PO Undergo Bone Scan Undergo PSMA PET Scan Given ADT undergo Questionnaire Administration |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall survival (OS)
Tidsram: From randomization to death due to any cause, assessed up to 10 years
|
Will determine OS. To assess the potential OS benefit from the triplet therapy, a group sequential efficacy/futility monitoring design will be employed. The planned analyses for OS will be tested using a one-sided type 1 error rate of 0.025. An intent-to-treat approach will be used to evaluate OS between treatments. The stratified logrank test will be the primary analysis to compare OS between treatments. The Kaplan-Meier estimate will be used to evaluate the within treatment OS distributions. In addition, the proportional hazards model will be applied to assess the treatment comparison adjusting for important covariates in predicting OS. |
From randomization to death due to any cause, assessed up to 10 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Survival (OS)
Tidsram: From randomization to death due to any cause, assessed up to 10 years
|
Will determine if the addition of docetaxel to androgen deprivation therapy and apalutamide improves OS for men whose cancers have alterations of P53, PTEN, or RB1. To assess the potential OS benefit from the triplet therapy, a group sequential efficacy/futility monitoring design will be employed. The planned analyses for OS will be tested using a one-sided type 1 error rate of 0.025. An intent-to-treat approach will be used to evaluate OS between treatments. The stratified logrank test will be the primary analysis to compare OS between treatments. The Kaplan-Meier estimate will be used to evaluate the within treatment OS distributions. In addition, the proportional hazards model will be applied to assess the treatment comparison adjusting for important covariates in predicting OS. |
From randomization to death due to any cause, assessed up to 10 years
|
|
Radiographic progression
Tidsram: From randomization to first documentation of radiographic progressive disease or death due to any cause, assessed up to 10 years
|
Will determine the time to radiographic progression- per Prostate Cancer Working Group (PCWG3) guidelines. Tumor response will be assessed utilizing imaging measurements, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. In this study, RECIST has been modified based on PCWG3 criteria, which are specific for this patient population. |
From randomization to first documentation of radiographic progressive disease or death due to any cause, assessed up to 10 years
|
|
Castration-resistant prostate cancer (CRPC)
Tidsram: Time to prostate-specific antigen progression with serum testosterone being at castrate level < 0.50 ng/mL, or the time to progression by soft tissue/visceral lesions or time to progression by bone lesions per PCWG3 guidelines, assessed up to 10 years
|
Will determine the time to CRPC |
Time to prostate-specific antigen progression with serum testosterone being at castrate level < 0.50 ng/mL, or the time to progression by soft tissue/visceral lesions or time to progression by bone lesions per PCWG3 guidelines, assessed up to 10 years
|
|
Symptomatic skeletal event free survival (SSE-FS)
Tidsram: From randomization to first occurrence of SSE or death from any cause, assessed up to 10 years
|
Will determine SSE-FS. An SSE is defined as external beam radiation therapy to relieve skeletal symptoms, or new symptomatic pathologic bone fracture, or occurrence of spinal cord compression or tumor-related orthopedic surgical intervention, whichever comes first |
From randomization to first occurrence of SSE or death from any cause, assessed up to 10 years
|
|
Worsening of physical symptoms of disease
Tidsram: up to 10 years
|
Will determine the time to worsening of physical symptoms of disease based on functional assessment of cancer therapy / National Comprehensive Cancer Network prostate cancer symptom index 17 item questionnaire. |
up to 10 years
|
|
Incidence of adverse events
Tidsram: up to 10 years
|
Will determine the safety and tolerability of the triplet versus doublet using Common Terminology Criteria for Adverse Events version 5.0. |
up to 10 years
|
|
Radiographic progression free survival (rPFS)
Tidsram: From randomization to first documentation of radiographic progressive disease or death due to any cause, assessed up to 10 years
|
Will determine rPFS in patients by the stratification factors a) timing/volume of disease 1) metachronous high volume, 2) synchronous high volume and 3) synchronous low volume metastases on conventional imaging. Tumor response will be assessed utilizing imaging measurements, as defined by RECIST 1.1. In this study, RECIST has been modified based on PCWG3 criteria, which are specific for this patient population. Evaluation of rPFS will be assessed by the investigator. |
From randomization to first documentation of radiographic progressive disease or death due to any cause, assessed up to 10 years
|
|
OS
Tidsram: Will determine OS in patients by the stratification factors a) timing/volume of disease 1) metachronous high volume, 2) synchronous high volume and 3) synchronous low volume metastases on conventional imaging. To assess the potential OS benefit from the
|
Will determine OS in patients by the stratification factors a) timing/volume of disease 1) metachronous high volume, 2) synchronous high volume and 3) synchronous low volume metastases on conventional imaging. To assess the potential OS benefit from the triplet therapy, a group sequential efficacy/futility monitoring design will be employed. The planned analyses for OS will be tested using a one-sided type 1 error rate of 0.025. An intent-to-treat approach will be used to evaluate OS between treatments. The stratified logrank test will be the primary analysis to compare OS between treatments. The Kaplan-Meier estimate will be used to evaluate the within treatment OS distributions. In addition, the proportional hazards model will be applied to assess the treatment comparison adjusting for important covariates in predicting OS. |
Will determine OS in patients by the stratification factors a) timing/volume of disease 1) metachronous high volume, 2) synchronous high volume and 3) synchronous low volume metastases on conventional imaging. To assess the potential OS benefit from the
|
|
Prostate specific antigen (PSA) 90 response rate
Tidsram: At 6 weeks and 6 months
|
Will determine PSA 90 response rate. |
At 6 weeks and 6 months
|
|
Time to PSA progression
Tidsram: From randomization to the date of PSA progression based on PCWG3 criteria, assessed up to 10 years
|
Will determine PSA progression. PSA progression is defined as a ≥ 25% increase above the nadir (lowest screening or baseline) value, which is confirmed by a second value 3 or more weeks later, and an increase in absolute value of ≥ 2 ng/mL above nadir, at least 12 weeks from baseline. Subjects without PSA progression as of database cut-off, whether or not surviving, will be censored at the last total PSA lab assessment date. |
From randomization to the date of PSA progression based on PCWG3 criteria, assessed up to 10 years
|
|
Objective response rate (ORR)
Tidsram: up to 10 years
|
Will determine ORR in patients with measurable disease. Tumor response will be assessed utilizing imaging measurements, as defined by RECIST 1.1. In this study, RECIST has been modified based on PCWG3 criteria, which are specific for this patient population |
up to 10 years
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Estimates of treatment effect
Tidsram: up to 10 years.
|
Estimates of treatment effect and the corresponding 95% confidence intervals (CIs) will be provided as follows (with an understanding that sometimes the CI or estimate will not be computable because of scant data):
|
up to 10 years.
|
Samarbetspartners och utredare
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Genitala neoplasmer, manliga
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Genitala sjukdomar, manliga
- Prostatasjukdomar
- Manliga urogenitala sjukdomar
- Prostatiska neoplasmer
- Organiska kemikalier
- Undersökningstekniker
- Kolväten
- Cykloparaffiner
- Kolväten, alicyklisk
- Kolväten, cykliska
- Terpener
- Taxoids
- Cyklodekaner
- Gentare
- Kemitekniker, analytiska
- Spektrumanalys
- Docetaxel
- Magnetresonansspektroskopi
- apalutamid
Andra studie-ID-nummer
- A032302
- NCI-2025-00838 (Annan identifierare: NCI Clinical Trial Reporting Program)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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