전이성 전립선 암에 대한 일반적인 치료 (호르몬 요법 및 아팔 루타 미드)에 도세탁셀 (화학 요법)의 첨가를 테스트, Aspire Trial
전이성 케스트 레이트-민감성 전립선 암에 도세탁셀 첨가 (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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 3단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Shiva Baghaie, MPH
- 전화번호: (773) 702-9171
- 이메일: GUprotocols@alliancenctn.org
연구 장소
-
-
Arizona
-
Tucson, Arizona, 미국, 85719
- 모병
- Banner University Medical Center - Tucson
-
연락하다:
- Site Public Contact
- 이메일: UACC-IIT@uacc.arizona.edu
-
수석 연구원:
- Edward P. Gelmann
-
Tucson, Arizona, 미국, 85719
- 모병
- University of Arizona Cancer Center-North Campus
-
연락하다:
- Site Public Contact
- 이메일: UACC-IIT@uacc.arizona.edu
-
수석 연구원:
- Edward P. Gelmann
-
-
California
-
Dublin, California, 미국, 94568
- 모병
- Kaiser Permanente Dublin
-
수석 연구원:
- Andrea L. Harzstark
-
연락하다:
- Site Public Contact
- 전화번호: 877-642-4691
-
Fremont, California, 미국, 94538
- 모병
- Kaiser Permanente-Fremont
-
수석 연구원:
- Andrea L. Harzstark
-
연락하다:
- Site Public Contact
- 전화번호: 877-642-4691
- 이메일: Kpoct@kp.org
-
Fresno, California, 미국, 93720
- 모병
- Kaiser Permanente Fresno Orchard Plaza
-
수석 연구원:
- Andrea L. Harzstark
-
연락하다:
- Site Public Contact
- 전화번호: 833-574-2273
-
La Jolla, California, 미국, 92093
- 모병
- UC San Diego Moores Cancer Center
-
연락하다:
- Site Public Contact
- 전화번호: 858-822-5354
- 이메일: cancercto@ucsd.edu
-
수석 연구원:
- Yu-Wei Chen
-
Modesto, California, 미국, 95356
- 모병
- Kaiser Permanente-Modesto
-
수석 연구원:
- Andrea L. Harzstark
-
연락하다:
- Site Public Contact
- 전화번호: 877-642-4691
- 이메일: Kpoct@kp.org
-
Modesto, California, 미국, 95356
- 모병
- Kaiser Permanente- Modesto MOB II
-
수석 연구원:
- Andrea L. Harzstark
-
연락하다:
- Site Public Contact
- 전화번호: 877-642-4691
-
Oakland, California, 미국, 94611
- 모병
- Kaiser Permanente-Oakland
-
수석 연구원:
- Andrea L. Harzstark
-
연락하다:
- Site Public Contact
- 전화번호: 877-642-4691
- 이메일: Kpoct@kp.org
-
Rancho Mirage, California, 미국, 92270
- 모병
- Eisenhower Medical Center
-
수석 연구원:
- Delshad Ahmad
-
연락하다:
- Site Public Contact
- 전화번호: 760-834-3798
-
Roseville, California, 미국, 95661
- 모병
- Kaiser Permanente-Roseville
-
수석 연구원:
- Andrea L. Harzstark
-
연락하다:
- Site Public Contact
- 전화번호: 877-642-4691
- 이메일: Kpoct@kp.org
-
Sacramento, California, 미국, 95814
- 모병
- Kaiser Permanente Downtown Commons
-
수석 연구원:
- Andrea L. Harzstark
-
연락하다:
- Site Public Contact
- 전화번호: 877-642-4691
- 이메일: kpoct@kp.org
-
Sacramento, California, 미국, 95823
- 모병
- Kaiser Permanente-South Sacramento
-
수석 연구원:
- Andrea L. Harzstark
-
연락하다:
- Site Public Contact
- 전화번호: 877-642-4691
- 이메일: Kpoct@kp.org
-
San Diego, California, 미국, 92103
- 모병
- UC San Diego Medical Center - Hillcrest
-
연락하다:
- Site Public Contact
- 이메일: rhabbaba@health.ucsd.edu
-
수석 연구원:
- Yu-Wei Chen
-
San Francisco, California, 미국, 94115
- 모병
- Kaiser Permanente-San Francisco
-
수석 연구원:
- Andrea L. Harzstark
-
연락하다:
- Site Public Contact
- 전화번호: 877-642-4691
- 이메일: Kpoct@kp.org
-
San Jose, California, 미국, 95119
- 모병
- Kaiser Permanente-Santa Teresa-San Jose
-
수석 연구원:
- Andrea L. Harzstark
-
연락하다:
- Site Public Contact
- 전화번호: 877-642-4691
- 이메일: Kpoct@kp.org
-
San Leandro, California, 미국, 94577
- 모병
- Kaiser Permanente San Leandro
-
수석 연구원:
- Andrea L. Harzstark
-
연락하다:
- Site Public Contact
- 전화번호: 877-642-4691
- 이메일: Kpoct@kp.org
-
San Rafael, California, 미국, 94903
- 모병
- Kaiser San Rafael-Gallinas
-
수석 연구원:
- Andrea L. Harzstark
-
연락하다:
- Site Public Contact
- 전화번호: 877-642-4691
- 이메일: Kpoct@kp.org
-
Santa Clara, California, 미국, 95051
- 모병
- Kaiser Permanente Medical Center - Santa Clara
-
수석 연구원:
- Andrea L. Harzstark
-
연락하다:
- Site Public Contact
- 전화번호: 877-642-4691
- 이메일: Kpoct@kp.org
-
Santa Rosa, California, 미국, 95403
- 모병
- Kaiser Permanente-Santa Rosa
-
수석 연구원:
- Andrea L. Harzstark
-
연락하다:
- Site Public Contact
- 전화번호: 877-642-4691
- 이메일: Kpoct@kp.org
-
South San Francisco, California, 미국, 94080
- 모병
- Kaiser Permanente-South San Francisco
-
수석 연구원:
- Andrea L. Harzstark
-
연락하다:
- Site Public Contact
- 전화번호: 877-642-4691
- 이메일: Kpoct@kp.org
-
Vallejo, California, 미국, 94589
- 모병
- Kaiser Permanente-Vallejo
-
수석 연구원:
- Andrea L. Harzstark
-
연락하다:
- Site Public Contact
- 전화번호: 877-642-4691
- 이메일: Kpoct@kp.org
-
Walnut Creek, California, 미국, 94596
- 모병
- Kaiser Permanente-Walnut Creek
-
수석 연구원:
- Andrea L. Harzstark
-
연락하다:
- Site Public Contact
- 전화번호: 877-642-4691
- 이메일: Kpoct@kp.org
-
-
Colorado
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Aurora, Colorado, 미국, 80045
- 모병
- Rocky Mountain Regional VA Medical Center
-
연락하다:
- Site Public Contact
- 전화번호: 888-336-8262
-
수석 연구원:
- Jessica D. McDermott
-
Denver, Colorado, 미국, 80205
- 모병
- Kaiser Permanente-Franklin
-
수석 연구원:
- Matthew J. Eadens
-
연락하다:
- Site Public Contact
- 전화번호: 303-817-9295
- 이메일: KPCOIHRClinicalResearch@kp.org
-
Edwards, Colorado, 미국, 81632
- 모병
- Shaw Cancer Center
-
연락하다:
- Site Public Contact
- 전화번호: 970-569-7429
-
수석 연구원:
- Erin Schwab
-
Grand Junction, Colorado, 미국, 81501
- 모병
- Saint Mary's Hospital and Regional Medical Center
-
연락하다:
- Site Public Contact
- 전화번호: 303-777-2663
- 이메일: ccrp@co-cancerresearch.org
-
수석 연구원:
- Wallace Jones
-
Lafayette, Colorado, 미국, 80026
- 모병
- Kaiser Permanente-Rock Creek
-
수석 연구원:
- Matthew J. Eadens
-
연락하다:
- Site Public Contact
- 전화번호: 303-817-9295
- 이메일: KPCOIHRClinicalResearch@kp.org
-
Lone Tree, Colorado, 미국, 80124
- 모병
- Kaiser Permanente-Lone Tree
-
수석 연구원:
- Matthew J. Eadens
-
연락하다:
- Site Public Contact
- 전화번호: 303-817-9295
- 이메일: KPCOIHRClinicalResearch@kp.org
-
-
Delaware
-
Dover, Delaware, 미국, 19901
- 모집하지 않고 적극적으로
- Bayhealth Hospital Kent Campus
-
Milford, Delaware, 미국, 19963
- 모집하지 않고 적극적으로
- Bayhealth Hospital Sussex Campus
-
-
District of Columbia
-
Washington D.C., District of Columbia, 미국, 20007
- 모병
- MedStar Georgetown University Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 202-444-2223
-
수석 연구원:
- Suthee Rapisuwon
-
Washington D.C., District of Columbia, 미국, 20010
- 모병
- MedStar Washington Hospital Center
-
연락하다:
- Site Public Contact
- 전화번호: 202-877-8839
-
수석 연구원:
- Suthee Rapisuwon
-
-
Florida
-
Gainesville, Florida, 미국, 32610
- 모병
- Malcom Randall Veterans Administration Medical Center
-
연락하다:
- Site Public Contact
- 전화번호: 352-273-8675
- 이메일: trials@cancer.ufl.edu
-
수석 연구원:
- Jess DeLaune
-
-
Georgia
-
Atlanta, Georgia, 미국, 30342
- 모병
- Northside Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 404-303-3355
- 이메일: ClinicalTrials@northside.com
-
수석 연구원:
- Shailesh R. Satpute
-
Duluth, Georgia, 미국, 30096
- 모병
- Northside Hospital - Duluth
-
연락하다:
- Site Public Contact
- 전화번호: 404-303-3355
- 이메일: Clinical.trials@northside.com
-
수석 연구원:
- Shailesh R. Satpute
-
Lawrenceville, Georgia, 미국, 30046
- 모병
- Northside Hospital - Gwinnett
-
연락하다:
- Site Public Contact
- 전화번호: 404-303-3355
- 이메일: Clinical.trials@northside.com
-
수석 연구원:
- Shailesh R. Satpute
-
-
Hawaii
-
Honolulu, Hawaii, 미국, 96819
- 모병
- Kaiser Permanente Moanalua Medical Center
-
수석 연구원:
- Andrea L. Harzstark
-
연락하다:
- Site Public Contact
- 전화번호: 808-432-5195
- 이메일: shelley.a.clark@kp.org
-
-
Idaho
-
Boise, Idaho, 미국, 83712
- 모병
- Saint Luke's Cancer Institute - Boise
-
수석 연구원:
- Alison K. Conlin
-
연락하다:
- Site Public Contact
- 전화번호: 208-381-2774
- 이메일: eslinget@slhs.org
-
Coeur d'Alene, Idaho, 미국, 83814
- 모병
- Kootenai Health - Coeur d'Alene
-
수석 연구원:
- John M. Schallenkamp
-
연락하다:
- Site Public Contact
- 전화번호: 406-969-6060
- 이메일: mccinfo@mtcancer.org
-
Fruitland, Idaho, 미국, 83619
- 모병
- Saint Luke's Cancer Institute - Fruitland
-
수석 연구원:
- Alison K. Conlin
-
연락하다:
- Site Public Contact
- 전화번호: 208-381-2774
- 이메일: eslinget@slhs.org
-
Meridian, Idaho, 미국, 83642
- 모병
- Saint Luke's Cancer Institute - Meridian
-
수석 연구원:
- Alison K. Conlin
-
연락하다:
- Site Public Contact
- 전화번호: 208-381-2774
- 이메일: eslinget@slhs.org
-
Nampa, Idaho, 미국, 83687
- 모병
- Saint Luke's Cancer Institute - Nampa
-
수석 연구원:
- Alison K. Conlin
-
연락하다:
- Site Public Contact
- 전화번호: 208-381-2774
- 이메일: eslinget@slhs.org
-
Post Falls, Idaho, 미국, 83854
- 모병
- Kootenai Clinic Cancer Services - Post Falls
-
수석 연구원:
- John M. Schallenkamp
-
연락하다:
- Site Public Contact
- 전화번호: 406-969-6060
- 이메일: mccinfo@mtcancer.org
-
Sandpoint, Idaho, 미국, 83864
- 모병
- Kootenai Clinic Cancer Services - Sandpoint
-
수석 연구원:
- John M. Schallenkamp
-
연락하다:
- Site Public Contact
- 전화번호: 406-969-6060
- 이메일: mccinfo@mtcancer.org
-
-
Illinois
-
Bloomington, Illinois, 미국, 61704
- 모병
- Illinois CancerCare-Bloomington
-
연락하다:
- Site Public Contact
- 전화번호: 309-243-3605
- 이메일: andersonj@illinoiscancercare.com
-
수석 연구원:
- Bryan A. Faller
-
Canton, Illinois, 미국, 61520
- 모병
- Illinois CancerCare-Canton
-
연락하다:
- Site Public Contact
- 전화번호: 309-243-3605
- 이메일: andersonj@illinoiscancercare.com
-
수석 연구원:
- Bryan A. Faller
-
Carthage, Illinois, 미국, 62321
- 모병
- Illinois CancerCare-Carthage
-
연락하다:
- Site Public Contact
- 전화번호: 309-243-3605
- 이메일: andersonj@illinoiscancercare.com
-
수석 연구원:
- Bryan A. Faller
-
Centralia, Illinois, 미국, 62801
- 모병
- Centralia Oncology Clinic
-
수석 연구원:
- Bryan A. Faller
-
연락하다:
- Site Public Contact
- 전화번호: 217-876-4762
- 이메일: morganthaler.jodi@mhsil.com
-
Chicago, Illinois, 미국, 60612
- 모병
- University of Illinois
-
연락하다:
- Site Public Contact
- 전화번호: 312-355-3046
-
수석 연구원:
- Karine Tawagi
-
Chicago, Illinois, 미국, 60612
- 모병
- Rush MD Anderson Cancer Center
-
수석 연구원:
- Manan Shah
-
연락하다:
- Site Public Contact
- 전화번호: 312-226-2371
- 이메일: Cancer_Studies@rush.edu
-
Danville, Illinois, 미국, 61832
- 모병
- Carle at The Riverfront
-
수석 연구원:
- Kendrith M. Rowland
-
연락하다:
- Site Public Contact
- 전화번호: 800-446-5532
- 이메일: Research@Carle.com
-
Decatur, Illinois, 미국, 62526
- 모병
- Cancer Care Specialists of Illinois - Decatur
-
수석 연구원:
- Bryan A. Faller
-
연락하다:
- Site Public Contact
- 전화번호: 217-876-4762
- 이메일: morganthaler.jodi@mhsil.com
-
Decatur, Illinois, 미국, 62526
- 모병
- Decatur Memorial Hospital
-
수석 연구원:
- Bryan A. Faller
-
연락하다:
- Site Public Contact
- 전화번호: 217-876-4762
- 이메일: morganthaler.jodi@mhsil.com
-
Dixon, Illinois, 미국, 61021
- 모병
- Illinois CancerCare-Dixon
-
수석 연구원:
- Bryan A. Faller
-
연락하다:
- Site Public Contact
- 전화번호: 815-285-7800
-
Effingham, Illinois, 미국, 62401
- 모병
- Carle Physician Group-Effingham
-
연락하다:
- Site Public Contact
- 전화번호: 800-446-5532
- 이메일: Research@carle.com
-
수석 연구원:
- Kendrith M. Rowland
-
Effingham, Illinois, 미국, 62401
- 모병
- Crossroads Cancer Center
-
수석 연구원:
- Bryan A. Faller
-
연락하다:
- Site Public Contact
- 전화번호: 217-876-4762
- 이메일: morganthaler.jodi@mhsil.com
-
Eureka, Illinois, 미국, 61530
- 모병
- Illinois CancerCare-Eureka
-
연락하다:
- Site Public Contact
- 전화번호: 309-243-3605
- 이메일: andersonj@illinoiscancercare.com
-
수석 연구원:
- Bryan A. Faller
-
Galesburg, Illinois, 미국, 61401
- 모병
- Illinois CancerCare-Galesburg
-
연락하다:
- Site Public Contact
- 전화번호: 309-243-3605
- 이메일: andersonj@illinoiscancercare.com
-
수석 연구원:
- Bryan A. Faller
-
Hines, Illinois, 미국, 60141
- 모병
- Edward Hines Jr VA Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 708-202-8387
-
수석 연구원:
- Elizabeth Henry
-
Kewanee, Illinois, 미국, 61443
- 모병
- Illinois CancerCare-Kewanee Clinic
-
연락하다:
- Site Public Contact
- 전화번호: 309-243-3605
- 이메일: andersonj@illinoiscancercare.com
-
수석 연구원:
- Bryan A. Faller
-
Macomb, Illinois, 미국, 61455
- 모병
- Illinois CancerCare-Macomb
-
연락하다:
- Site Public Contact
- 전화번호: 309-243-3605
- 이메일: andersonj@illinoiscancercare.com
-
수석 연구원:
- Bryan A. Faller
-
Mattoon, Illinois, 미국, 61938
- 모병
- Carle Physician Group-Mattoon/Charleston
-
연락하다:
- Site Public Contact
- 전화번호: 800-446-5532
- 이메일: Research@carle.com
-
수석 연구원:
- Kendrith M. Rowland
-
Mount Vernon, Illinois, 미국, 62864
- 모병
- SSM Health Good Samaritan
-
수석 연구원:
- Jay W. Carlson
-
연락하다:
- Site Public Contact
- 전화번호: 618-899-1894
- 이메일: gayla.hall@ssmhealth.com
-
Normal, Illinois, 미국, 61761
- 모병
- Carle BroMenn Medical Center
-
수석 연구원:
- Kendrith M. Rowland
-
연락하다:
- Site Public Contact
- 전화번호: 800-446-5532
- 이메일: Research@Carle.com
-
Normal, Illinois, 미국, 61761
- 모병
- Carle Cancer Institute Normal
-
수석 연구원:
- Kendrith M. Rowland
-
연락하다:
- Site Public Contact
- 전화번호: 800-446-5532
- 이메일: Research@Carle.com
-
O'Fallon, Illinois, 미국, 62269
- 모병
- Cancer Care Center of O'Fallon
-
수석 연구원:
- Bryan A. Faller
-
연락하다:
- Site Public Contact
- 전화번호: 217-876-4762
- 이메일: morganthaler.jodi@mhsil.com
-
O'Fallon, Illinois, 미국, 62269
- 모병
- HSHS Saint Elizabeth's Hospital
-
수석 연구원:
- Bryan A. Faller
-
연락하다:
- Site Public Contact
- 전화번호: 217-876-4762
- 이메일: morganthaler.jodi@mhsil.com
-
Ottawa, Illinois, 미국, 61350
- 모병
- Illinois CancerCare-Ottawa Clinic
-
연락하다:
- Site Public Contact
- 전화번호: 309-243-3605
- 이메일: andersonj@illinoiscancercare.com
-
수석 연구원:
- Bryan A. Faller
-
Pekin, Illinois, 미국, 61554
- 모병
- Illinois CancerCare-Pekin
-
연락하다:
- Site Public Contact
- 전화번호: 309-243-3605
- 이메일: andersonj@illinoiscancercare.com
-
수석 연구원:
- Bryan A. Faller
-
Peoria, Illinois, 미국, 61615
- 모병
- Illinois CancerCare-Peoria
-
연락하다:
- Site Public Contact
- 전화번호: 309-243-3605
- 이메일: andersonj@illinoiscancercare.com
-
수석 연구원:
- Bryan A. Faller
-
Peru, Illinois, 미국, 61354
- 모병
- Illinois CancerCare-Peru
-
연락하다:
- Site Public Contact
- 전화번호: 309-243-3605
- 이메일: andersonj@illinoiscancercare.com
-
수석 연구원:
- Bryan A. Faller
-
Princeton, Illinois, 미국, 61356
- 모병
- Illinois CancerCare-Princeton
-
연락하다:
- Site Public Contact
- 전화번호: 309-243-3605
- 이메일: andersonj@illinoiscancercare.com
-
수석 연구원:
- Bryan A. Faller
-
Shiloh, Illinois, 미국, 62269
- 모병
- Memorial Hospital East
-
연락하다:
- Site Public Contact
- 전화번호: 314-747-9912
- 이메일: dschwab@wustl.edu
-
수석 연구원:
- Eric M. Knoche
-
Springfield, Illinois, 미국, 62702
- 모병
- Southern Illinois University School of Medicine
-
수석 연구원:
- Bryan A. Faller
-
연락하다:
- Site Public Contact
- 전화번호: 217-545-7929
-
Springfield, Illinois, 미국, 62702
- 모병
- Springfield Clinic
-
수석 연구원:
- Bryan A. Faller
-
연락하다:
- Site Public Contact
- 전화번호: 800-444-7541
-
Springfield, Illinois, 미국, 62781
- 모병
- Springfield Memorial Hospital
-
수석 연구원:
- Bryan A. Faller
-
연락하다:
- Site Public Contact
- 전화번호: 217-528-7541
- 이메일: pallante.beth@mhsil.com
-
Urbana, Illinois, 미국, 61801
- 모병
- Carle Cancer Center
-
연락하다:
- Site Public Contact
- 전화번호: 800-446-5532
- 이메일: Research@carle.com
-
수석 연구원:
- Kendrith M. Rowland
-
Washington, Illinois, 미국, 61571
- 모병
- Illinois CancerCare - Washington
-
연락하다:
- Site Public Contact
- 전화번호: 309-243-3605
- 이메일: andersonj@illinoiscancercare.com
-
수석 연구원:
- Bryan A. Faller
-
-
Iowa
-
Ames, Iowa, 미국, 50010
- 모병
- Mary Greeley Medical Center
-
수석 연구원:
- Joseph J. Merchant
-
연락하다:
- Site Public Contact
- 전화번호: 515-956-4132
-
Ames, Iowa, 미국, 50010
- 모병
- McFarland Clinic - Ames
-
수석 연구원:
- Joseph J. Merchant
-
연락하다:
- Site Public Contact
- 전화번호: 515-239-4734
- 이메일: ksoder@mcfarlandclinic.com
-
Boone, Iowa, 미국, 50036
- 정지된
- McFarland Clinic - Boone
-
Cedar Rapids, Iowa, 미국, 52403
- 모병
- Mercy Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 319-365-4673
-
수석 연구원:
- Deborah W. Wilbur
-
Cedar Rapids, Iowa, 미국, 52403
- 모병
- Oncology Associates at Mercy Medical Center
-
수석 연구원:
- Deborah W. Wilbur
-
연락하다:
- Site Public Contact
- 전화번호: 319-363-2690
-
Fort Dodge, Iowa, 미국, 50501
- 모병
- McFarland Clinic - Trinity Cancer Center
-
수석 연구원:
- Joseph J. Merchant
-
연락하다:
- Site Public Contact
- 전화번호: 515-956-4132
-
Jefferson, Iowa, 미국, 50129
- 정지된
- McFarland Clinic - Jefferson
-
Marshalltown, Iowa, 미국, 50158
- 모병
- McFarland Clinic - Marshalltown
-
수석 연구원:
- Joseph J. Merchant
-
연락하다:
- Site Public Contact
- 전화번호: 515-956-4132
-
-
Kansas
-
Hays, Kansas, 미국, 67601
- 모병
- HaysMed
-
연락하다:
- Site Public Contact
- 전화번호: 785-623-5774
-
수석 연구원:
- Elizabeth M. Wulff
-
Lawrence, Kansas, 미국, 66044
- 모병
- Lawrence Memorial Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 785-505-2800
- 이메일: Stephanie.Norris@LMH.ORG
-
수석 연구원:
- Elizabeth M. Wulff
-
Olathe, Kansas, 미국, 66061
- 모병
- The University of Kansas Cancer Center - Olathe
-
연락하다:
- Site Public Contact
- 전화번호: 913-588-1569
- 이메일: OlatheCCResearch@kumc.edu
-
수석 연구원:
- Elizabeth M. Wulff
-
Overland Park, Kansas, 미국, 66210
- 모병
- University of Kansas Cancer Center-Overland Park
-
연락하다:
- Site Public Contact
- 전화번호: 913-588-3671
- 이메일: KUCC_Navigation@kumc.edu
-
수석 연구원:
- Elizabeth M. Wulff
-
Salina, Kansas, 미국, 67401
- 모병
- Salina Regional Health Center
-
연락하다:
- Site Public Contact
- 전화번호: 785-452-7038
- 이메일: mleepers@srhc.com
-
수석 연구원:
- Elizabeth M. Wulff
-
Topeka, Kansas, 미국, 66606
- 모병
- University of Kansas Health System Saint Francis Campus
-
연락하다:
- Site Public Contact
- 전화번호: 785-295-8000
-
수석 연구원:
- Elizabeth M. Wulff
-
Westwood, Kansas, 미국, 66205
- 모병
- University of Kansas Hospital-Westwood Cancer Center
-
연락하다:
- Site Public Contact
- 전화번호: 913-588-3671
- 이메일: KUCC_Navigation@kumc.edu
-
수석 연구원:
- Elizabeth M. Wulff
-
-
Michigan
-
Brighton, Michigan, 미국, 48114
- 모병
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
-
연락하다:
- Site Public Contact
- 전화번호: 734-712-7251
- 이메일: MCRCwebsitecontactform@stjoeshealth.org
-
수석 연구원:
- Christopher M. Reynolds
-
Canton, Michigan, 미국, 48188
- 모병
- Trinity Health IHA Medical Group Hematology Oncology - Canton
-
연락하다:
- Site Public Contact
- 전화번호: 734-712-7251
- 이메일: MCRCwebsitecontactform@stjoeshealth.org
-
수석 연구원:
- Christopher M. Reynolds
-
Chelsea, Michigan, 미국, 48118
- 모병
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 734-712-7251
- 이메일: MCRCwebsitecontactform@stjoeshealth.org
-
수석 연구원:
- Christopher M. Reynolds
-
Escanaba, Michigan, 미국, 49829
- 모병
- OSF Saint Francis Hospital and Medical Group
-
수석 연구원:
- Anthony J. Jaslowski
-
연락하다:
- Site Public Contact
- 전화번호: 920-433-8889
- 이메일: WI_research_admin@hshs.org
-
Flint, Michigan, 미국, 48503
- 모병
- Genesys Hurley Cancer Institute
-
수석 연구원:
- Christopher M. Reynolds
-
연락하다:
- Site Public Contact
- 전화번호: 810-762-8038
- 이메일: wstrong@ghci.org
-
Flint, Michigan, 미국, 48503
- 모병
- Hurley Medical Center
-
수석 연구원:
- Christopher M. Reynolds
-
연락하다:
- Site Public Contact
- 전화번호: 810-762-8038
- 이메일: wstrong@ghci.org
-
Flint, Michigan, 미국, 48503
- 모병
- Cancer Hematology Centers - Flint
-
수석 연구원:
- Christopher M. Reynolds
-
연락하다:
- Site Public Contact
- 전화번호: 810-762-8038
- 이메일: wstrong@ghci.org
-
Lansing, Michigan, 미국, 48912
- 모병
- University of Michigan Health - Sparrow Lansing
-
수석 연구원:
- Christopher M. Reynolds
-
연락하다:
- Site Public Contact
- 전화번호: 517-364-3712
- 이메일: harsha.trivedi@umhsparrow.org
-
Livonia, Michigan, 미국, 48154
- 모병
- Trinity Health Saint Mary Mercy Livonia Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 734-712-7251
- 이메일: MCRCwebsitecontactform@stjoeshealth.org
-
수석 연구원:
- Christopher M. Reynolds
-
Pontiac, Michigan, 미국, 48341
- 모병
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 734-712-7251
- 이메일: MCRCwebsitecontactform@stjoeshealth.org
-
수석 연구원:
- Christopher M. Reynolds
-
Ypsilanti, Michigan, 미국, 48197
- 모병
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
-
연락하다:
- Site Public Contact
- 전화번호: 734-712-7251
- 이메일: MCRCwebsitecontactform@stjoeshealth.org
-
수석 연구원:
- Christopher M. Reynolds
-
-
Minnesota
-
Bemidji, Minnesota, 미국, 56601
- 모병
- Sanford Joe Lueken Cancer Center
-
수석 연구원:
- Daniel Almquist
-
연락하다:
- Site Public Contact
- 전화번호: 218-333-5000
- 이메일: OncologyClinicalTrialsFargo@sanfordhealth.org
-
Saint Cloud, Minnesota, 미국, 56303
- 모병
- Coborn Cancer Center at Saint Cloud Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 877-229-4907
- 이메일: coborncancercenter@centracare.com
-
수석 연구원:
- Donald J. Jurgens
-
-
Missouri
-
Cape Girardeau, Missouri, 미국, 63703
- 모병
- Saint Francis Medical Center
-
수석 연구원:
- Bryan A. Faller
-
연락하다:
- Site Public Contact
- 전화번호: 573-334-2230
- 이메일: sfmc@sfmc.net
-
City of Saint Peters, Missouri, 미국, 63376
- 모병
- Siteman Cancer Center at Saint Peters Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 800-600-3606
- 이메일: info@siteman.wustl.edu
-
수석 연구원:
- Eric M. Knoche
-
Creve Coeur, Missouri, 미국, 63141
- 모병
- Siteman Cancer Center at West County Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 800-600-3606
- 이메일: info@siteman.wustl.edu
-
수석 연구원:
- Eric M. Knoche
-
Kansas City, Missouri, 미국, 64154
- 모병
- University of Kansas Cancer Center - North
-
연락하다:
- Site Public Contact
- 전화번호: 913-588-3671
- 이메일: KUCC_Navigation@kumc.edu
-
수석 연구원:
- Elizabeth M. Wulff
-
Kansas City, Missouri, 미국, 64108
- 모병
- University Health Truman Medical Center
-
연락하다:
- Site Public Contact
- 전화번호: 816-404-4375
-
수석 연구원:
- Elizabeth M. Wulff
-
Kansas City, Missouri, 미국, 64116
- 모병
- University of Kansas Cancer Center - Briarcliff
-
수석 연구원:
- Elizabeth M. Wulff
-
연락하다:
- Site Public Contact
- 전화번호: 913-588-3671
-
Lee's Summit, Missouri, 미국, 64064
- 모병
- University of Kansas Cancer Center - Lee's Summit
-
연락하다:
- Site Public Contact
- 전화번호: 913-588-3671
- 이메일: KUCC_Navigation@kumc.edu
-
수석 연구원:
- Elizabeth M. Wulff
-
St Louis, Missouri, 미국, 63110
- 모병
- Washington University School of Medicine
-
연락하다:
- Site Public Contact
- 전화번호: 800-600-3606
- 이메일: info@siteman.wustl.edu
-
수석 연구원:
- Eric M. Knoche
-
St Louis, Missouri, 미국, 63128
- 모병
- Mercy Hospital South
-
수석 연구원:
- Jay W. Carlson
-
연락하다:
- Site Public Contact
- 전화번호: 314-525-6042
- 이메일: Danielle.Werle@mercy.net
-
St Louis, Missouri, 미국, 63141
- 모병
- Mercy Hospital Saint Louis
-
수석 연구원:
- Jay W. Carlson
-
연락하다:
- Site Public Contact
- 전화번호: 314-251-7066
-
St Louis, Missouri, 미국, 63129
- 모병
- Siteman Cancer Center-South County
-
연락하다:
- Site Public Contact
- 전화번호: 800-600-3606
- 이메일: info@siteman.wustl.edu
-
수석 연구원:
- Eric M. Knoche
-
St Louis, Missouri, 미국, 63136
- 모병
- Siteman Cancer Center at Christian Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 800-600-3606
- 이메일: info@siteman.wustl.edu
-
수석 연구원:
- Eric M. Knoche
-
St Louis, Missouri, 미국, 63125
- 모병
- Veteran's Affairs Medical Center - Saint Louis
-
연락하다:
- Site Public Contact
- 전화번호: 773-702-9171
- 이메일: protocols@AllianceNCTN.org
-
수석 연구원:
- Eric M. Knoche
-
-
Montana
-
Anaconda, Montana, 미국, 59711
- 모병
- Community Hospital of Anaconda
-
수석 연구원:
- John M. Schallenkamp
-
연락하다:
- Site Public Contact
- 전화번호: 406-969-6060
- 이메일: mccinfo@mtcancer.org
-
Billings, Montana, 미국, 59101
- 모병
- Billings Clinic Cancer Center
-
수석 연구원:
- John M. Schallenkamp
-
연락하다:
- Site Public Contact
- 전화번호: 800-996-2663
- 이메일: research@billingsclinic.org
-
Billings, Montana, 미국, 59102
- 모병
- Saint Vincent Frontier Cancer Center
-
연락하다:
- Site Public Contact
- 전화번호: 800-648-6274
-
수석 연구원:
- Wallace Jones
-
Bozeman, Montana, 미국, 59715
- 모병
- Bozeman Health Deaconess Hospital
-
수석 연구원:
- John M. Schallenkamp
-
연락하다:
- Site Public Contact
- 전화번호: 406-969-6060
- 이메일: mccinfo@mtcancer.org
-
Great Falls, Montana, 미국, 59405
- 모병
- Benefis Sletten Cancer Institute
-
수석 연구원:
- John M. Schallenkamp
-
연락하다:
- Site Public Contact
- 전화번호: 406-969-6060
- 이메일: mccinfo@mtcancer.org
-
Kalispell, Montana, 미국, 59901
- 모병
- Logan Health Medical Center
-
수석 연구원:
- John M. Schallenkamp
-
연락하다:
- Site Public Contact
- 전화번호: 406-969-6060
- 이메일: mccinfo@mtcancer.org
-
Missoula, Montana, 미국, 59804
- 모병
- Community Medical Center
-
수석 연구원:
- John M. Schallenkamp
-
연락하다:
- Site Public Contact
- 전화번호: 406-969-6060
- 이메일: mccinfo@mtcancer.org
-
-
New Jersey
-
Basking Ridge, New Jersey, 미국, 07920
- 모병
- Memorial Sloan Kettering Basking Ridge
-
연락하다:
- Site Public Contact
- 전화번호: 212-639-7592
-
수석 연구원:
- Kristine P. Lacuna
-
Cherry Hill, New Jersey, 미국, 08002
- 모병
- Jefferson Cherry Hill Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 215-600-9151
- 이메일: ONCTrialNow@jefferson.edu
-
수석 연구원:
- Kevin K. Zarrabi
-
Middletown, New Jersey, 미국, 07748
- 모병
- Memorial Sloan Kettering Monmouth
-
연락하다:
- Site Public Contact
- 전화번호: 212-639-7592
-
수석 연구원:
- Kristine P. Lacuna
-
Montvale, New Jersey, 미국, 07645
- 모병
- Memorial Sloan Kettering Bergen
-
연락하다:
- Site Public Contact
- 전화번호: 212-639-7592
-
수석 연구원:
- Kristine P. Lacuna
-
Sewell, New Jersey, 미국, 08080
- 모병
- Sidney Kimmel Cancer Center Washington Township
-
연락하다:
- Site Public Contact
- 전화번호: 215-600-9151
- 이메일: ONCTrialNow@jefferson.edu
-
수석 연구원:
- Kevin K. Zarrabi
-
-
New York
-
Buffalo, New York, 미국, 14263
- 모병
- Roswell Park Cancer Institute
-
연락하다:
- Site Public Contact
- 전화번호: 800-767-9355
- 이메일: askroswell@roswellpark.org
-
수석 연구원:
- Ellis G. Levine
-
Commack, New York, 미국, 11725
- 모병
- Memorial Sloan Kettering Commack
-
연락하다:
- Site Public Contact
- 전화번호: 212-639-7592
-
수석 연구원:
- Kristine P. Lacuna
-
Cortland, New York, 미국, 13045
- 모병
- Guthrie Cortland Memorial Hospital
-
수석 연구원:
- Alina Basnet
-
연락하다:
- Site Public Contact
- 전화번호: 607-756-3130
-
Harrison, New York, 미국, 10604
- 모병
- Memorial Sloan Kettering Westchester
-
연락하다:
- Site Public Contact
- 전화번호: 212-639-7592
-
수석 연구원:
- Kristine P. Lacuna
-
New York, New York, 미국, 10065
- 모병
- Memorial Sloan Kettering Cancer Center
-
연락하다:
- Site Public Contact
- 전화번호: 212-639-7592
-
수석 연구원:
- Kristine P. Lacuna
-
New York, New York, 미국, 10029
- 모병
- Mount Sinai Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 212-824-7309
- 이메일: CCTO@mssm.edu
-
수석 연구원:
- Eric J. Miller
-
Stony Brook, New York, 미국, 11794
- 모병
- Stony Brook University Medical Center
-
연락하다:
- Site Public Contact
- 전화번호: 800-862-2215
-
수석 연구원:
- Judy Huang
-
Uniondale, New York, 미국, 11553
- 모병
- Memorial Sloan Kettering Nassau
-
연락하다:
- Site Public Contact
- 전화번호: 212-639-7592
-
수석 연구원:
- Kristine P. Lacuna
-
-
North Carolina
-
Durham, North Carolina, 미국, 27710
- 모병
- Duke University Medical Center
-
연락하다:
- Site Public Contact
- 전화번호: 888-275-3853
-
수석 연구원:
- Hannah D. McManus
-
Durham, North Carolina, 미국, 27705
- 모병
- Durham VA Medical Center
-
연락하다:
- Site Public Contact
- 전화번호: 919-286-0411
- 이메일: VHADURcancertrials@va.gov
-
수석 연구원:
- Rhonda L. Bitting
-
Pinehurst, North Carolina, 미국, 28374
- 모병
- FirstHealth of the Carolinas-Moore Regional Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 910-715-3500
- 이메일: jcwilliams@firsthealth.org
-
수석 연구원:
- Charles S. Kuzma
-
-
North Dakota
-
Bismarck, North Dakota, 미국, 58501
- 모병
- Sanford Bismarck Medical Center
-
수석 연구원:
- Daniel Almquist
-
연락하다:
- Site Public Contact
- 전화번호: 701-323-5760
- 이메일: OncologyClinicalTrialsFargo@sanfordhealth.org
-
Fargo, North Dakota, 미국, 58122
- 모병
- Sanford Broadway Medical Center
-
수석 연구원:
- Daniel Almquist
-
연락하다:
- Site Public Contact
- 전화번호: 701-323-5760
- 이메일: OncologyClinicalTrialsFargo@sanfordhealth.org
-
Fargo, North Dakota, 미국, 58122
- 모병
- Sanford Roger Maris Cancer Center
-
수석 연구원:
- Daniel Almquist
-
연락하다:
- Site Public Contact
- 전화번호: 701-234-6161
- 이메일: OncologyClinicalTrialsFargo@sanfordhealth.org
-
-
Ohio
-
Canton, Ohio, 미국, 44710
- 모병
- Aultman Health Foundation
-
연락하다:
- Site Public Contact
- 전화번호: 330-363-7274
- 이메일: ClinicalReserachDept@aultman.com
-
수석 연구원:
- Mehool A. Patel
-
Columbus, Ohio, 미국, 43210
- 모병
- Ohio State University Comprehensive Cancer Center
-
연락하다:
- Site Public Contact
- 전화번호: 800-293-5066
- 이메일: Jamesline@osumc.edu
-
수석 연구원:
- Lingbin Meng
-
Sylvania, Ohio, 미국, 43560
- 모병
- ProMedica Flower Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 419-824-1842
- 이메일: PCIOncResearch@promedica.org
-
수석 연구원:
- Jeffrey H. Muler
-
-
Oklahoma
-
Oklahoma City, Oklahoma, 미국, 73104
- 모병
- University of Oklahoma Health Sciences Center
-
연락하다:
- Site Public Contact
- 전화번호: 405-271-8777
- 이메일: ou-clinical-trials@ouhsc.edu
-
수석 연구원:
- Adanma Anji Ayanambakkam Attanathi
-
-
Pennsylvania
-
Erie, Pennsylvania, 미국, 16544
- 모병
- Saint Vincent Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 814-452-5000
-
수석 연구원:
- Shifeng S. Mao
-
Jefferson Hills, Pennsylvania, 미국, 15025
- 모병
- Jefferson Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 412-359-3043
- 이메일: ddefazio@wpahs.org
-
수석 연구원:
- Shifeng S. Mao
-
Monroeville, Pennsylvania, 미국, 15146
- 모병
- Forbes Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 412-858-7746
-
수석 연구원:
- Shifeng S. Mao
-
Natrona Heights, Pennsylvania, 미국, 15065
- 모병
- Allegheny Valley Hospital
-
연락하다:
- Site Public Contact
- 이메일: Dawnmarie.DeFazio@ahn.org
-
수석 연구원:
- Shifeng S. Mao
-
Philadelphia, Pennsylvania, 미국, 19107
- 모병
- Thomas Jefferson University Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 215-600-9151
- 이메일: ONCTrialNow@jefferson.edu
-
수석 연구원:
- Kevin K. Zarrabi
-
Philadelphia, Pennsylvania, 미국, 19148
- 정지된
- Jefferson Methodist Hospital
-
Philadelphia, Pennsylvania, 미국, 19114
- 모병
- Jefferson Torresdale Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 215-600-9151
- 이메일: ONCTrialNow@jefferson.edu
-
수석 연구원:
- Kevin K. Zarrabi
-
Pittsburgh, Pennsylvania, 미국, 15224
- 모병
- West Penn Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 412-578-5000
-
수석 연구원:
- Shifeng S. Mao
-
Pittsburgh, Pennsylvania, 미국, 15212
- 모병
- Allegheny General Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 877-284-2000
-
수석 연구원:
- Shifeng S. Mao
-
Sayre, Pennsylvania, 미국, 18840
- 모병
- Guthrie Medical Group PC-Robert Packer Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 800-836-0388
-
수석 연구원:
- Joyson Poulose
-
Wexford, Pennsylvania, 미국, 15090
- 모병
- Wexford Health and Wellness Pavilion
-
연락하다:
- Site Public Contact
- 이메일: Dawnmarie.DeFazio@ahn.org
-
수석 연구원:
- Shifeng S. Mao
-
Willow Grove, Pennsylvania, 미국, 19090
- 모병
- Asplundh Cancer Pavilion
-
연락하다:
- Site Public Contact
- 전화번호: 215-600-9151
- 이메일: ONCTrialNow@jefferson.edu
-
수석 연구원:
- Kevin K. Zarrabi
-
-
South Carolina
-
Greenville, South Carolina, 미국, 29601
- 모병
- Saint Francis Hospital
-
수석 연구원:
- Stephen H. Dyar
-
연락하다:
- Site Public Contact
- 전화번호: 864-603-6234
- 이메일: Heather_Rich@bshsi.org
-
Greenville, South Carolina, 미국, 29607
- 모병
- Saint Francis Cancer Center
-
수석 연구원:
- Stephen H. Dyar
-
연락하다:
- Site Public Contact
- 전화번호: 864-603-6234
- 이메일: Heather_Rich@bshsi.org
-
Greenwood, South Carolina, 미국, 29646
- 모병
- Self Regional Healthcare
-
연락하다:
- Site Public Contact
- 전화번호: 864-725-4771
- 이메일: nmcgaha@selfregional.org
-
수석 연구원:
- Albert C. Lockhart
-
-
South Dakota
-
Rapid City, South Dakota, 미국, 57701
- 모집하지 않고 적극적으로
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, 미국, 57104
- 모병
- Sanford Cancer Center Oncology Clinic
-
수석 연구원:
- Daniel Almquist
-
연락하다:
- Site Public Contact
- 전화번호: 605-312-3320
- 이메일: OncologyClinicTrialsSF@sanfordhealth.org
-
Sioux Falls, South Dakota, 미국, 57117-5134
- 모병
- Sanford USD Medical Center - Sioux Falls
-
수석 연구원:
- Daniel Almquist
-
연락하다:
- Site Public Contact
- 전화번호: 605-312-3320
- 이메일: OncologyClinicalTrialsSF@SanfordHealth.org
-
-
Texas
-
Dallas, Texas, 미국, 75390
- 모병
- UT Southwestern/Simmons Cancer Center-Dallas
-
연락하다:
- Site Public Contact
- 전화번호: 214-648-7097
- 이메일: canceranswerline@UTSouthwestern.edu
-
수석 연구원:
- Qian Qin
-
Dallas, Texas, 미국, 75237
- 모병
- UT Southwestern Simmons Cancer Center - RedBird
-
수석 연구원:
- Qian Qin
-
연락하다:
- Site Public Contact
- 전화번호: 214-648-7097
- 이메일: canceranswerline@utsouthwestern.edu
-
Fort Worth, Texas, 미국, 76104
- 모병
- UT Southwestern/Simmons Cancer Center-Fort Worth
-
연락하다:
- Site Public Contact
- 전화번호: 214-648-7097
- 이메일: canceranswerline@UTSouthwestern.edu
-
수석 연구원:
- Qian Qin
-
Richardson, Texas, 미국, 75080
- 모병
- UT Southwestern Clinical Center at Richardson/Plano
-
연락하다:
- Site Public Contact
- 전화번호: 972-669-7044
- 이메일: Suzanne.cole@utsouthwestern.edu
-
수석 연구원:
- Qian Qin
-
-
Utah
-
Murray, Utah, 미국, 84107
- 모병
- Intermountain Medical Center
-
연락하다:
- Site Public Contact
- 전화번호: 801-507-3950
- 이메일: officeofresearch@imail.org
-
수석 연구원:
- Wallace Jones
-
Ogden, Utah, 미국, 84403
- 모병
- McKay-Dee Hospital Center
-
연락하다:
- Site Public Contact
- 전화번호: 801-387-7426
- 이메일: officeofresearch@imail.org
-
수석 연구원:
- Wallace Jones
-
Salt Lake City, Utah, 미국, 84143
- 모병
- LDS Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 801-408-1347
- 이메일: officeofresearch@imail.org
-
수석 연구원:
- Wallace Jones
-
Sandy City, Utah, 미국, 84094
- 모병
- Intermountain Health Alta View Hospital
-
수석 연구원:
- Wallace Jones
-
연락하다:
- Site Public Contact
- 이메일: IntermountainResearch@imail.org
-
St. George, Utah, 미국, 84770
- 모병
- Saint George Regional Medical Center
-
연락하다:
- Site Public Contact
- 전화번호: 833-321-3332
- 이메일: officeofresearch@imail.org
-
수석 연구원:
- Wallace Jones
-
-
Vermont
-
Berlin Corners, Vermont, 미국, 05602
- 모병
- Central Vermont Medical Center/National Life Cancer Treatment
-
연락하다:
- Site Public Contact
- 전화번호: 802-225-5400
-
수석 연구원:
- Rahul Anil
-
Burlington, Vermont, 미국, 05401
- 모병
- University of Vermont Medical Center
-
연락하다:
- Site Public Contact
- 전화번호: 802-656-4101
- 이메일: rpo@uvm.edu
-
수석 연구원:
- Rahul Anil
-
Burlington, Vermont, 미국, 05405
- 모병
- University of Vermont and State Agricultural College
-
연락하다:
- Site Public Contact
- 전화번호: 802-656-8990
- 이메일: rpo@uvm.edu
-
수석 연구원:
- Rahul Anil
-
-
Virginia
-
Fredericksburg, Virginia, 미국, 22408
- 모병
- Hematology Oncology Associates of Fredericksburg Inc
-
연락하다:
- Site Public Contact
- 전화번호: 540-371-0079
- 이메일: cvaughn@hoafredericksburg.com
-
수석 연구원:
- Asit K. Paul
-
Richmond, Virginia, 미국, 23235
- 모병
- VCU Massey Cancer Center at Stony Point
-
연락하다:
- Site Public Contact
- 이메일: ctoclinops@vcu.edu
-
수석 연구원:
- Asit K. Paul
-
Richmond, Virginia, 미국, 23298
- 모병
- VCU Massey Comprehensive Cancer Center
-
수석 연구원:
- Asit K. Paul
-
연락하다:
- Site Public Contact
- 전화번호: 804-628-6430
- 이메일: CTOclinops@vcu.edu
-
Tappahannock, Virginia, 미국, 22560
- 모병
- VCU Health Tappahannock Hospital
-
수석 연구원:
- Asit K. Paul
-
연락하다:
- Site Public Contact
- 이메일: klcampbell@vcu.edu
-
-
West Virginia
-
Charleston, West Virginia, 미국, 25304
- 모병
- Vandalia Health/CAMC Institute for Academic Medicine
-
수석 연구원:
- Kok Hoe Chan
-
연락하다:
- Site Public Contact
- 전화번호: 304-388-9944
- 이메일: CAMCClinicalTrials@vandaliahealth.org
-
-
Wisconsin
-
Antigo, Wisconsin, 미국, 54409
- 모병
- Aspirus Cancer Care-Antigo-Volm Cancer Center
-
연락하다:
- Site Public Contact
- 전화번호: 715-623-9869
- 이메일: Juli.Alford@aspirus.org
-
수석 연구원:
- Andrew J. Huang
-
Appleton, Wisconsin, 미국, 54911
- 모병
- ThedaCare Regional Cancer Center
-
연락하다:
- Site Public Contact
- 전화번호: 920-364-3604
- 이메일: ResearchDept@thedacare.org
-
수석 연구원:
- Joyce Philip
-
Appleton, Wisconsin, 미국, 54915
- 모병
- Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
-
수석 연구원:
- Kamal Kant Singh Abbi
-
연락하다:
- Site Public Contact
- 이메일: AWRI.inquiry@ascension.org
-
Brookfield, Wisconsin, 미국, 53045
- 모병
- Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield
-
수석 연구원:
- Kamal Kant Singh Abbi
-
연락하다:
- Site Public Contact
- 이메일: AWRI.Inquiry@Ascension.org
-
Chilton, Wisconsin, 미국, 53014
- 모병
- Ascension Calumet Hospital-Chilton
-
수석 연구원:
- Kamal Kant Singh Abbi
-
연락하다:
- Site Public Contact
- 이메일: AWRI.inquiry@ascension.org
-
Franklin, Wisconsin, 미국, 53132
- 모병
- Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson
-
수석 연구원:
- Kamal Kant Singh Abbi
-
연락하다:
- Site Public Contact
- 이메일: AWRI.Inquiry@Ascension.org
-
Green Bay, Wisconsin, 미국, 54301
- 모병
- Saint Vincent Hospital Cancer Center Green Bay
-
수석 연구원:
- Anthony J. Jaslowski
-
연락하다:
- Site Public Contact
- 전화번호: 920-433-8889
- 이메일: WI_research_admin@hshs.org
-
Green Bay, Wisconsin, 미국, 54303
- 모병
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
수석 연구원:
- Anthony J. Jaslowski
-
연락하다:
- Site Public Contact
- 전화번호: 920-433-8889
- 이메일: wi_research_admin@hshs.org
-
Madison, Wisconsin, 미국, 53705
- 모병
- William S Middleton VA Medical Center
-
수석 연구원:
- David Kosoff
-
연락하다:
- Site Public Contact
- 전화번호: 17007 608-256-1901
-
Medford, Wisconsin, 미국, 54451
- 모병
- Aspirus Medford Hospital
-
수석 연구원:
- Andrew J. Huang
-
연락하다:
- Site Public Contact
- 전화번호: 715-847-2353
- 이메일: Beth.Knetter@aspirus.org
-
Menomonee Falls, Wisconsin, 미국, 53051
- 모병
- Froedtert Menomonee Falls Hospital
-
연락하다:
- Site Public Contact
- 전화번호: 262-257-5100
-
수석 연구원:
- Deepak Kilari
-
Mequon, Wisconsin, 미국, 53097
- 모병
- Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon
-
수석 연구원:
- Kamal Kant Singh Abbi
-
연락하다:
- Site Public Contact
- 이메일: AWRI.Inquiry@Ascension.org
-
Milwaukee, Wisconsin, 미국, 53226
- 모병
- Medical College of Wisconsin
-
연락하다:
- Site Public Contact
- 전화번호: 414-805-3666
-
수석 연구원:
- Deepak Kilari
-
Milwaukee, Wisconsin, 미국, 53295
- 모병
- Zablocki Veterans Administration Medical Center
-
연락하다:
- Site Public Contact
- 전화번호: 888-469-6614
-
수석 연구원:
- Sumana Devata
-
Milwaukee, Wisconsin, 미국, 53211
- 모병
- Ascension Columbia Saint Mary's Hospital-Milwaukee Campus
-
수석 연구원:
- Kamal Kant Singh Abbi
-
연락하다:
- Site Public Contact
- 이메일: AWRI.Inquiry@Ascension.org
-
New Berlin, Wisconsin, 미국, 53151
- 모병
- Froedtert and MCW Moorland Reserve Health Center
-
수석 연구원:
- Deepak Kilari
-
연락하다:
- Site Public Contact
- 전화번호: 414-805-0505
-
Oak Creek, Wisconsin, 미국, 53154
- 모병
- Drexel Town Square Health Center
-
수석 연구원:
- Deepak Kilari
-
연락하다:
- Site Public Contact
- 전화번호: 414-805-0505
-
Oconto Falls, Wisconsin, 미국, 54154
- 모병
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
수석 연구원:
- Anthony J. Jaslowski
-
연락하다:
- Site Public Contact
- 전화번호: 920-433-8889
- 이메일: WI_research_admin@hshs.org
-
Oshkosh, Wisconsin, 미국, 54904
- 모병
- Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh
-
수석 연구원:
- Kamal Kant Singh Abbi
-
연락하다:
- Site Public Contact
- 이메일: AWRI.inquiry@ascension.org
-
Racine, Wisconsin, 미국, 53405
- 모병
- Ascension All Saints Hospital-Spring Street-Racine
-
수석 연구원:
- Kamal Kant Singh Abbi
-
연락하다:
- Site Public Contact
- 이메일: AWRI.Inquiry@Ascension.org
-
Rhinelander, Wisconsin, 미국, 54501
- 모병
- Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
-
수석 연구원:
- Andrew J. Huang
-
연락하다:
- Site Public Contact
- 전화번호: 715-847-2353
- 이메일: Beth.Knetter@aspirus.org
-
Sheboygan, Wisconsin, 미국, 53081
- 모병
- Saint Vincent Hospital Cancer Center at Sheboygan
-
수석 연구원:
- Anthony J. Jaslowski
-
연락하다:
- Site Public Contact
- 전화번호: 920-433-8889
- 이메일: wi_research_admin@hshs.org
-
Sheboygan, Wisconsin, 미국, 53081
- 모병
- Sheboygan Physicians Group
-
수석 연구원:
- Anthony J. Jaslowski
-
연락하다:
- Site Public Contact
- 전화번호: 920-433-8889
- 이메일: wi_research_admin@hshs.org
-
Stevens Point, Wisconsin, 미국, 54481
- 모병
- Aspirus Cancer Care - Stevens Point
-
수석 연구원:
- Andrew J. Huang
-
연락하다:
- Site Public Contact
- 전화번호: 715-847-2353
- 이메일: Beth.Knetter@aspirus.org
-
Sturgeon Bay, Wisconsin, 미국, 54235-1495
- 모병
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
-
수석 연구원:
- Anthony J. Jaslowski
-
연락하다:
- Site Public Contact
- 전화번호: 920-433-8889
- 이메일: wi_research_admin@hshs.org
-
Wausau, Wisconsin, 미국, 54401
- 모병
- Aspirus Cancer Care-Wausau
-
수석 연구원:
- Andrew J. Huang
-
연락하다:
- Site Public Contact
- 전화번호: 877-405-6866
-
Wauwatosa, Wisconsin, 미국, 53226
- 모병
- Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa
-
수석 연구원:
- Kamal Kant Singh Abbi
-
연락하다:
- Site Public Contact
- 이메일: AWRI.Inquiry@Ascension.org
-
West Bend, Wisconsin, 미국, 53095
- 모병
- Froedtert West Bend Hospital/Kraemer Cancer Center
-
수석 연구원:
- Deepak Kilari
-
연락하다:
- Site Public Contact
- 전화번호: 414-805-0505
-
Wisconsin Rapids, Wisconsin, 미국, 54494
- 모병
- Aspirus Cancer Care - Wisconsin Rapids
-
수석 연구원:
- Andrew J. Huang
-
연락하다:
- Site Public Contact
- 전화번호: 715-422-7718
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: 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
다른 이름들:
Undergo MRI
다른 이름들:
Given PO Undergo Bone Scan Undergo PSMA PET Scan Given ADT undergo Questionnaire Administration |
|
실험적: 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
다른 이름들:
Undergo blood sample collection Undergo CT
다른 이름들:
Undergo MRI
다른 이름들:
Given PO Undergo Bone Scan Undergo PSMA PET Scan Given ADT undergo Questionnaire Administration |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall survival (OS)
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival (OS)
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: At 6 weeks and 6 months
|
Will determine PSA 90 response rate. |
At 6 weeks and 6 months
|
|
Time to PSA progression
기간: 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)
기간: 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
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Estimates of treatment effect
기간: 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.
|
공동 작업자 및 조사자
협력자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- A032302
- NCI-2025-00838 (기타 식별자: NCI Clinical Trial Reporting Program)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .