Testování přerušení hormonálních léků u pacientů, kteří výjimečně reagují na léčbu metastatického karcinomu prostaty (A-DREAM) (A-DREAM)
Studie fáze 2 přerušení ADT u pacientů výjimečně reagujících na inhibitor AR dráhy u metastatického hormonálně senzitivního karcinomu prostaty (MHSPC): A-DREAM
This phase II trial examines antiandrogen therapy interruptions in patients with hormone-sensitive prostate cancer that has spread to other places in the body (metastatic) responding exceptionally well to androgen receptor-pathway inhibitor therapy. The usual treatment for patients with metastatic prostate cancer is to receive hormonal medications including a medication to decrease testosterone levels in the body and a potent oral hormonal medication to block growth signals from male hormones (like testosterone) in the cancer cells. Patients whose cancer is responding exceptionally well to this therapy may take a break from these medications according to their doctor's guidance. This trial may help doctors determine if stopping treatment can allow for testosterone recovery.
Přehled studie
Postavení
Detailní popis
PRIMARY OBJECTIVE:
I. To determine the proportion of men who experience 18-month treatment-free interval from therapy with eugonadal testosterone (to >= 150 ng/ml) after treatment interruption.
SECONDARY OBJECTIVES:
I. To determine time to eugonadal testosterone (> 150 ng/dl). II. To determine duration off-treatment.
III. To assess changes in quality of life as follows:
- To assess changes in patient-reported quality of life as assessed by the Functional Assessment of Cancer Therapy- Prostate (FACT-P) total score from baseline to 24 months after treatment interruption.
- To assess changes in the FACT-P subscales (i.e., physical well-being, social and family well-being, emotional well-being, functional well-being, and prostate cancer subscale) from baseline to 24 months after treatment interruption.
- To assess changes in the FACT-P total score and subscales (i.e., physical well-being, social and family well-being, emotional well-being, functional well-being, and prostate cancer subscale) from baseline to the remaining post-baseline time points (i.e., 6, 12, and 18 months) after treatment interruption.
OUTLINE:
Patients stop both hormonal medications (medication to decrease testosterone levels in the body and potent oral hormonal medication to block growth signals from male hormones in the cancer cells). Patients are then followed every 12 months for symptoms. Patients with an increase in prostate specific antigen (PSA) level to greater than or equal to 5 ng/ml, changes on imaging studies suggesting that their cancer is growing back, or symptoms that the doctor thinks is related to their cancer growing back, resume both hormonal treatments.
After completion of study treatment, patients are followed up every 6 months for 10 years from registration or withdrawal from the study or death.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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Arizona
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Phoenix, Arizona, Spojené státy, 85004
- Cancer Center at Saint Joseph's
-
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Arkansas
-
Fort Smith, Arkansas, Spojené státy, 72903
- Mercy Hospital Fort Smith
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Little Rock, Arkansas, Spojené státy, 72205
- CARTI Cancer Center
-
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California
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Arroyo Grande, California, Spojené státy, 93420
- Mission Hope Medical Oncology - Arroyo Grande
-
Carmichael, California, Spojené státy, 95608
- Mercy San Juan Medical Center
-
Carmichael, California, Spojené státy, 95608
- Mercy Cancer Center �� Carmichael
-
Dublin, California, Spojené státy, 94568
- Epic Care-Dublin
-
Elk Grove, California, Spojené státy, 95758
- Mercy Cancer Center - Elk Grove
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Emeryville, California, Spojené státy, 94608
- Bay Area Breast Surgeons Inc
-
Emeryville, California, Spojené státy, 94608
- Epic Care Partners in Cancer Care
-
Martinez, California, Spojené státy, 94553-3156
- Contra Costa Regional Medical Center
-
Merced, California, Spojené státy, 95340
- Mercy UC Davis Cancer Center
-
Oakland, California, Spojené státy, 94609
- Bay Area Tumor Institute
-
Orange, California, Spojené státy, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
-
Rancho Mirage, California, Spojené státy, 92270
- Eisenhower Medical Center
-
Rocklin, California, Spojené státy, 95765
- Mercy Cancer Center - Rocklin
-
Sacramento, California, Spojené státy, 95816
- Mercy Cancer Center - Sacramento
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San Luis Obispo, California, Spojené státy, 93401
- Pacific Central Coast Health Center-San Luis Obispo
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Santa Maria, California, Spojené státy, 93444
- Mission Hope Medical Oncology - Santa Maria
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Walnut Creek, California, Spojené státy, 94597
- Epic Care Cyberknife Center
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Woodland, California, Spojené státy, 95695
- Woodland Memorial Hospital
-
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Colorado
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Aurora, Colorado, Spojené státy, 80045
- Rocky Mountain Regional VA Medical Center
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Colorado Springs, Colorado, Spojené státy, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Spojené státy, 80907
- Rocky Mountain Cancer Centers-Penrose
-
Colorado Springs, Colorado, Spojené státy, 80923
- Saint Francis Cancer Center
-
Denver, Colorado, Spojené státy, 80210
- Porter Adventist Hospital
-
Durango, Colorado, Spojené státy, 81301
- Mercy Medical Center
-
Durango, Colorado, Spojené státy, 81301
- Southwest Oncology PC
-
Lakewood, Colorado, Spojené státy, 80228
- Saint Anthony Hospital
-
Littleton, Colorado, Spojené státy, 80122
- Littleton Adventist Hospital
-
Longmont, Colorado, Spojené státy, 80501
- Longmont United Hospital
-
Parker, Colorado, Spojené státy, 80138
- Parker Adventist Hospital
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Pueblo, Colorado, Spojené státy, 81004
- Saint Mary Corwin Medical Center
-
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Florida
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Aventura, Florida, Spojené státy, 33180
- UM Sylvester Comprehensive Cancer Center at Aventura
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Coral Gables, Florida, Spojené státy, 33146
- UM Sylvester Comprehensive Cancer Center at Coral Gables
-
Deerfield Beach, Florida, Spojené státy, 33442
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Miami, Florida, Spojené státy, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
-
Miami, Florida, Spojené státy, 33176
- UM Sylvester Comprehensive Cancer Center at Kendall
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Plantation, Florida, Spojené státy, 33324
- UM Sylvester Comprehensive Cancer Center at Plantation
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Idaho
-
Boise, Idaho, Spojené státy, 83706
- Saint Alphonsus Cancer Care Center-Boise
-
Caldwell, Idaho, Spojené státy, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
-
Coeur d'Alene, Idaho, Spojené státy, 83814
- Kootenai Health - Coeur d'Alene
-
Emmett, Idaho, Spojené státy, 83617
- Walter Knox Memorial Hospital
-
Meridian, Idaho, Spojené státy, 83642
- Idaho Urologic Institute-Meridian
-
Nampa, Idaho, Spojené státy, 83687
- Saint Alphonsus Cancer Care Center-Nampa
-
Post Falls, Idaho, Spojené státy, 83854
- Kootenai Clinic Cancer Services - Post Falls
-
Sandpoint, Idaho, Spojené státy, 83864
- Kootenai Cancer Clinic
-
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Illinois
-
Alton, Illinois, Spojené státy, 62002
- Saint Anthony's Health
-
Bloomington, Illinois, Spojené státy, 61704
- Illinois CancerCare-Bloomington
-
Canton, Illinois, Spojené státy, 61520
- Illinois CancerCare-Canton
-
Carbondale, Illinois, Spojené státy, 62902
- Memorial Hospital of Carbondale
-
Carterville, Illinois, Spojené státy, 62918
- SIH Cancer Institute
-
Carthage, Illinois, Spojené státy, 62321
- Illinois CancerCare-Carthage
-
Centralia, Illinois, Spojené státy, 62801
- Centralia Oncology Clinic
-
Centralia, Illinois, Spojené státy, 62801
- Saint Mary's Hospital
-
Chicago, Illinois, Spojené státy, 60611
- Northwestern University
-
Chicago, Illinois, Spojené státy, 60637
- University of Chicago Comprehensive Cancer Center
-
DeKalb, Illinois, Spojené státy, 60115
- Northwestern Medicine Cancer Center Kishwaukee
-
Decatur, Illinois, Spojené státy, 62526
- Decatur Memorial Hospital
-
Decatur, Illinois, Spojené státy, 62526
- Cancer Care Specialists of Illinois - Decatur
-
Dixon, Illinois, Spojené státy, 61021
- Illinois CancerCare-Dixon
-
Effingham, Illinois, Spojené státy, 62401
- Crossroads Cancer Center
-
Eureka, Illinois, Spojené státy, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, Spojené státy, 61401
- Western Illinois Cancer Treatment Center
-
Galesburg, Illinois, Spojené státy, 61401
- Illinois CancerCare-Galesburg
-
Geneva, Illinois, Spojené státy, 60134
- Northwestern Medicine Cancer Center Delnor
-
Harvey, Illinois, Spojené státy, 60426
- Ingalls Memorial Hospital
-
Kewanee, Illinois, Spojené státy, 61443
- Illinois CancerCare-Kewanee Clinic
-
Lake Forest, Illinois, Spojené státy, 60045
- Northwestern Medicine Lake Forest Hospital
-
Macomb, Illinois, Spojené státy, 61455
- Illinois CancerCare-Macomb
-
Mount Vernon, Illinois, Spojené státy, 62864
- Good Samaritan Regional Health Center
-
New Lenox, Illinois, Spojené státy, 60451
- UC Comprehensive Cancer Center at Silver Cross
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O'Fallon, Illinois, Spojené státy, 62269
- Cancer Care Center of O'Fallon
-
O'Fallon, Illinois, Spojené státy, 62269
- HSHS Saint Elizabeth's Hospital
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Orland Park, Illinois, Spojené státy, 60462
- University of Chicago Medicine-Orland Park
-
Orland Park, Illinois, Spojené státy, 60462
- Northwestern Medicine Orland Park
-
Ottawa, Illinois, Spojené státy, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Spojené státy, 61554
- Illinois CancerCare-Pekin
-
Pekin, Illinois, Spojené státy, 61554
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
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Peoria, Illinois, Spojené státy, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Spojené státy, 61637
- OSF Saint Francis Medical Center
-
Peoria, Illinois, Spojené státy, 61615
- Illinois CancerCare-Peoria
-
Peoria, Illinois, Spojené státy, 61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
-
Peru, Illinois, Spojené státy, 61354
- Illinois CancerCare-Peru
-
Peru, Illinois, Spojené státy, 61354
- Valley Radiation Oncology
-
Princeton, Illinois, Spojené státy, 61356
- Illinois CancerCare-Princeton
-
Shiloh, Illinois, Spojené státy, 62269
- Memorial Hospital East
-
Springfield, Illinois, Spojené státy, 62781
- Memorial Medical Center
-
Springfield, Illinois, Spojené státy, 62702
- Southern Illinois University School of Medicine
-
Springfield, Illinois, Spojené státy, 62702
- Springfield Clinic
-
Warrenville, Illinois, Spojené státy, 60555
- Northwestern Medicine Cancer Center Warrenville
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Washington, Illinois, Spojené státy, 61571
- Illinois CancerCare - Washington
-
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Indiana
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Richmond, Indiana, Spojené státy, 47374
- Reid Health
-
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Iowa
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Ames, Iowa, Spojené státy, 50010
- Mary Greeley Medical Center
-
Ames, Iowa, Spojené státy, 50010
- McFarland Clinic - Ames
-
Boone, Iowa, Spojené státy, 50036
- McFarland Clinic - Boone
-
Clive, Iowa, Spojené státy, 50325
- Mercy Cancer Center-West Lakes
-
Clive, Iowa, Spojené státy, 50325
- Medical Oncology and Hematology Associates-West Des Moines
-
Council Bluffs, Iowa, Spojené státy, 51503
- Alegent Health Mercy Hospital
-
Creston, Iowa, Spojené státy, 50801
- Greater Regional Medical Center
-
Des Moines, Iowa, Spojené státy, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Spojené státy, 50314
- Mission Cancer and Blood - Laurel
-
Fort Dodge, Iowa, Spojené státy, 50501
- McFarland Clinic - Trinity Cancer Center
-
Jefferson, Iowa, Spojené státy, 50129
- McFarland Clinic - Jefferson
-
Marshalltown, Iowa, Spojené státy, 50158
- McFarland Clinic - Marshalltown
-
West Des Moines, Iowa, Spojené státy, 50266
- Mercy Medical Center-West Lakes
-
-
Kansas
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Garden City, Kansas, Spojené státy, 67846
- Central Care Cancer Center - Garden City
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Great Bend, Kansas, Spojené státy, 67530
- Central Care Cancer Center - Great Bend
-
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Kentucky
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Bardstown, Kentucky, Spojené státy, 40004
- Flaget Memorial Hospital
-
Corbin, Kentucky, Spojené státy, 40701
- Commonwealth Cancer Center-Corbin
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Lexington, Kentucky, Spojené státy, 40504
- Saint Joseph Radiation Oncology Resource Center
-
Lexington, Kentucky, Spojené státy, 40509
- Saint Joseph Hospital East
-
Lexington, Kentucky, Spojené státy, 40504
- Saint Joseph Hospital
-
London, Kentucky, Spojené státy, 40741
- Saint Joseph London
-
Mount Sterling, Kentucky, Spojené státy, 40353
- Saint Joseph Mount Sterling
-
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02215
- Dana-Farber Cancer Institute
-
Foxborough, Massachusetts, Spojené státy, 02035
- Dana-Farber Cancer Institute at Foxborough
-
Milford, Massachusetts, Spojené státy, 01757
- Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
-
South Weymouth, Massachusetts, Spojené státy, 02190
- Dana-Farber/Brigham and Women's Cancer Center at South Shore
-
Worcester, Massachusetts, Spojené státy, 01655
- UMass Memorial Medical Center - University Campus
-
-
Michigan
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Adrian, Michigan, Spojené státy, 49221
- Hickman Cancer Center
-
Ann Arbor, Michigan, Spojené státy, 48106
- Saint Joseph Mercy Hospital
-
Ann Arbor, Michigan, Spojené státy, 48109
- University of Michigan Comprehensive Cancer Center
-
Brighton, Michigan, Spojené státy, 48114
- Saint Joseph Mercy Brighton
-
Brighton, Michigan, Spojené státy, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
-
Brighton, Michigan, Spojené státy, 48116
- University of Michigan - Brighton Center for Specialty Care
-
Canton, Michigan, Spojené státy, 48188
- Saint Joseph Mercy Canton
-
Canton, Michigan, Spojené státy, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
-
Caro, Michigan, Spojené státy, 48723
- Caro Cancer Center
-
Chelsea, Michigan, Spojené státy, 48118
- Saint Joseph Mercy Chelsea
-
Chelsea, Michigan, Spojené státy, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Clarkston, Michigan, Spojené státy, 48346
- Hematology Oncology Consultants-Clarkston
-
Clarkston, Michigan, Spojené státy, 48346
- Newland Medical Associates-Clarkston
-
Detroit, Michigan, Spojené státy, 48236
- Ascension Saint John Hospital
-
East China, Michigan, Spojené státy, 48054
- Great Lakes Cancer Management Specialists-Doctors Park
-
Flint, Michigan, Spojené státy, 48503
- Hurley Medical Center
-
Flint, Michigan, Spojené státy, 48503
- Genesee Cancer and Blood Disease Treatment Center
-
Flint, Michigan, Spojené státy, 48503
- Genesee Hematology Oncology PC
-
Flint, Michigan, Spojené státy, 48503
- Genesys Hurley Cancer Institute
-
Grosse Pointe Woods, Michigan, Spojené státy, 48236
- Academic Hematology Oncology Specialists
-
Grosse Pointe Woods, Michigan, Spojené státy, 48236
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
-
Grosse Pointe Woods, Michigan, Spojené státy, 48236
- Michigan Breast Specialists-Grosse Pointe Woods
-
Lansing, Michigan, Spojené státy, 48912
- University of Michigan Health - Sparrow Lansing
-
Livonia, Michigan, Spojené státy, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Macomb, Michigan, Spojené státy, 48044
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
-
Macomb, Michigan, Spojené státy, 48044
- Michigan Breast Specialists-Macomb Township
-
Marlette, Michigan, Spojené státy, 48453
- Saint Mary's Oncology/Hematology Associates of Marlette
-
Monroe, Michigan, Spojené státy, 48162
- Toledo Clinic Cancer Centers-Monroe
-
Pontiac, Michigan, Spojené státy, 48341
- Saint Joseph Mercy Oakland
-
Pontiac, Michigan, Spojené státy, 48341
- 21st Century Oncology-Pontiac
-
Pontiac, Michigan, Spojené státy, 48341
- Hope Cancer Center
-
Pontiac, Michigan, Spojené státy, 48341
- Newland Medical Associates-Pontiac
-
Saginaw, Michigan, Spojené státy, 48601
- Ascension Saint Mary's Hospital
-
Saginaw, Michigan, Spojené státy, 48604
- Oncology Hematology Associates of Saginaw Valley PC
-
Sterling Heights, Michigan, Spojené státy, 48312
- Bhadresh Nayak MD PC-Sterling Heights
-
Tawas City, Michigan, Spojené státy, 48764
- Ascension Saint Joseph Hospital
-
Warren, Michigan, Spojené státy, 48093
- Saint John Macomb-Oakland Hospital
-
Warren, Michigan, Spojené státy, 48088
- Advanced Breast Care Center PLLC
-
Warren, Michigan, Spojené státy, 48093
- Great Lakes Cancer Management Specialists-Macomb Professional Building
-
Warren, Michigan, Spojené státy, 48093
- Macomb Hematology Oncology PC
-
Warren, Michigan, Spojené státy, 48093
- Michigan Breast Specialists-Warren
-
West Branch, Michigan, Spojené státy, 48661
- Saint Mary's Oncology/Hematology Associates of West Branch
-
Ypsilanti, Michigan, Spojené státy, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
-
Ypsilanti, Michigan, Spojené státy, 48106
- Huron Gastroenterology PC
-
-
Minnesota
-
Bemidji, Minnesota, Spojené státy, 56601
- Sanford Joe Lueken Cancer Center
-
Burnsville, Minnesota, Spojené státy, 55337
- Fairview Ridges Hospital
-
Burnsville, Minnesota, Spojené státy, 55337
- Minnesota Oncology - Burnsville
-
Cambridge, Minnesota, Spojené státy, 55008
- Cambridge Medical Center
-
Coon Rapids, Minnesota, Spojené státy, 55433
- Mercy Hospital
-
Edina, Minnesota, Spojené státy, 55435
- Fairview Southdale Hospital
-
Fridley, Minnesota, Spojené státy, 55432
- Unity Hospital
-
Maple Grove, Minnesota, Spojené státy, 55369
- Fairview Clinics and Surgery Center Maple Grove
-
Maplewood, Minnesota, Spojené státy, 55109
- Saint John's Hospital - Healtheast
-
Maplewood, Minnesota, Spojené státy, 55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis, Minnesota, Spojené státy, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, Spojené státy, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, Spojené státy, 55454
- Health Partners Inc
-
Monticello, Minnesota, Spojené státy, 55362
- Monticello Cancer Center
-
New Ulm, Minnesota, Spojené státy, 56073
- New Ulm Medical Center
-
Princeton, Minnesota, Spojené státy, 55371
- Fairview Northland Medical Center
-
Robbinsdale, Minnesota, Spojené státy, 55422
- North Memorial Medical Health Center
-
Saint Louis Park, Minnesota, Spojené státy, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Paul, Minnesota, Spojené státy, 55101
- Regions Hospital
-
Saint Paul, Minnesota, Spojené státy, 55102
- United Hospital
-
Shakopee, Minnesota, Spojené státy, 55379
- Saint Francis Regional Medical Center
-
Stillwater, Minnesota, Spojené státy, 55082
- Lakeview Hospital
-
Thief River Falls, Minnesota, Spojené státy, 56701
- Sanford Thief River Falls Medical Center
-
Waconia, Minnesota, Spojené státy, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, Spojené státy, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, Spojené státy, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
Worthington, Minnesota, Spojené státy, 56187
- Sanford Cancer Center Worthington
-
Wyoming, Minnesota, Spojené státy, 55092
- Fairview Lakes Medical Center
-
-
Missouri
-
Ballwin, Missouri, Spojené státy, 63011
- Saint Louis Cancer and Breast Institute-Ballwin
-
Bolivar, Missouri, Spojené státy, 65613
- Central Care Cancer Center - Bolivar
-
Branson, Missouri, Spojené státy, 65616
- Cox Cancer Center Branson
-
Cape Girardeau, Missouri, Spojené státy, 63703
- Saint Francis Medical Center
-
Cape Girardeau, Missouri, Spojené státy, 63703
- Southeast Cancer Center
-
City of Saint Peters, Missouri, Spojené státy, 63376
- Siteman Cancer Center at Saint Peters Hospital
-
Creve Coeur, Missouri, Spojené státy, 63141
- Siteman Cancer Center at West County Hospital
-
Farmington, Missouri, Spojené státy, 63640
- Parkland Health Center - Farmington
-
Jefferson City, Missouri, Spojené státy, 65109
- Capital Region Southwest Campus
-
Joplin, Missouri, Spojené státy, 64804
- Freeman Health System
-
Joplin, Missouri, Spojené státy, 64804
- Mercy Hospital Joplin
-
Osage Beach, Missouri, Spojené státy, 65065
- Lake Regional Hospital
-
Rolla, Missouri, Spojené státy, 65401
- Delbert Day Cancer Institute at PCRMC
-
Rolla, Missouri, Spojené státy, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
-
Saint Joseph, Missouri, Spojené státy, 64506
- Heartland Regional Medical Center
-
Sainte Genevieve, Missouri, Spojené státy, 63670
- Sainte Genevieve County Memorial Hospital
-
Springfield, Missouri, Spojené státy, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, Spojené státy, 65804
- Mercy Hospital Springfield
-
St Louis, Missouri, Spojené státy, 63110
- Washington University School of Medicine
-
St Louis, Missouri, Spojené státy, 63129
- Siteman Cancer Center-South County
-
St Louis, Missouri, Spojené státy, 63136
- Siteman Cancer Center at Christian Hospital
-
St Louis, Missouri, Spojené státy, 63131
- Missouri Baptist Medical Center
-
St Louis, Missouri, Spojené státy, 63141
- Mercy Hospital Saint Louis
-
St Louis, Missouri, Spojené státy, 63128
- Mercy Hospital South
-
St Louis, Missouri, Spojené státy, 63109
- Saint Louis Cancer and Breast Institute-South City
-
Sullivan, Missouri, Spojené státy, 63080
- Missouri Baptist Sullivan Hospital
-
Sunset Hills, Missouri, Spojené státy, 63127
- BJC Outpatient Center at Sunset Hills
-
Washington, Missouri, Spojené státy, 63090
- Mercy Hospital Washington
-
-
Montana
-
Anaconda, Montana, Spojené státy, 59711
- Community Hospital of Anaconda
-
Billings, Montana, Spojené státy, 59101
- Billings Clinic Cancer Center
-
Bozeman, Montana, Spojené státy, 59715
- Bozeman Deaconess Hospital
-
Great Falls, Montana, Spojené státy, 59405
- Great Falls Clinic
-
Great Falls, Montana, Spojené státy, 59405
- Benefis Healthcare- Sletten Cancer Institute
-
Kalispell, Montana, Spojené státy, 59901
- Kalispell Regional Medical Center
-
Missoula, Montana, Spojené státy, 59804
- Community Medical Hospital
-
-
Nebraska
-
Grand Island, Nebraska, Spojené státy, 68803
- CHI Health Saint Francis
-
Kearney, Nebraska, Spojené státy, 68847
- CHI Health Good Samaritan
-
Lincoln, Nebraska, Spojené státy, 68510
- Saint Elizabeth Regional Medical Center
-
Omaha, Nebraska, Spojené státy, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, Spojené státy, 68122
- Alegent Health Immanuel Medical Center
-
Omaha, Nebraska, Spojené státy, 68130
- Alegent Health Lakeside Hospital
-
Omaha, Nebraska, Spojené státy, 68131
- Creighton University Medical Center
-
Papillion, Nebraska, Spojené státy, 68046
- Midlands Community Hospital
-
-
New Jersey
-
Basking Ridge, New Jersey, Spojené státy, 07920
- Memorial Sloan Kettering Basking Ridge
-
Lakewood, New Jersey, Spojené státy, 08701
- Monmouth Medical Center Southern Campus
-
Livingston, New Jersey, Spojené státy, 07039
- Saint Barnabas Medical Center
-
Long Branch, New Jersey, Spojené státy, 07740
- Monmouth Medical Center
-
Middletown, New Jersey, Spojené státy, 07748
- Memorial Sloan Kettering Monmouth
-
Montvale, New Jersey, Spojené státy, 07645
- Memorial Sloan Kettering Bergen
-
New Brunswick, New Jersey, Spojené státy, 08903
- Rutgers Cancer Institute of New Jersey
-
Toms River, New Jersey, Spojené státy, 08755
- Community Medical Center
-
-
New York
-
Commack, New York, Spojené státy, 11725
- Memorial Sloan Kettering Commack
-
East White Plains, New York, Spojené státy, 10604
- Memorial Sloan Kettering Westchester
-
Middletown, New York, Spojené státy, 10940
- Garnet Health Medical Center
-
New York, New York, Spojené státy, 10065
- Memorial Sloan Kettering Cancer Center
-
Oswego, New York, Spojené státy, 13126
- Upstate Cancer Center at Oswego
-
Syracuse, New York, Spojené státy, 13210
- State University of New York Upstate Medical University
-
Syracuse, New York, Spojené státy, 13215
- SUNY Upstate Medical Center-Community Campus
-
The Bronx, New York, Spojené státy, 10461
- Montefiore Medical Center-Einstein Campus
-
The Bronx, New York, Spojené státy, 10467
- Montefiore Medical Center - Moses Campus
-
The Bronx, New York, Spojené státy, 10461
- Montefiore Medical Center-Weiler Hospital
-
Uniondale, New York, Spojené státy, 11553
- Memorial Sloan Kettering Nassau
-
Verona, New York, Spojené státy, 13478
- Upstate Cancer Center at Verona
-
-
North Carolina
-
Hendersonville, North Carolina, Spojené státy, 28791
- Margaret R Pardee Memorial Hospital
-
-
North Dakota
-
Bismarck, North Dakota, Spojené státy, 58501
- Sanford Bismarck Medical Center
-
Fargo, North Dakota, Spojené státy, 58122
- Sanford Roger Maris Cancer Center
-
Fargo, North Dakota, Spojené státy, 58122
- Sanford Broadway Medical Center
-
Fargo, North Dakota, Spojené státy, 58103
- Sanford South University Medical Center
-
Fargo, North Dakota, Spojené státy, 58103
- Southpointe-Sanford Medical Center Fargo
-
Fargo, North Dakota, Spojené státy, 58104
- Sanford Medical Center Fargo
-
-
Ohio
-
Beavercreek, Ohio, Spojené státy, 45431
- Indu and Raj Soin Medical Center
-
Boardman, Ohio, Spojené státy, 44512
- Saint Elizabeth Boardman Hospital
-
Centerville, Ohio, Spojené státy, 45459
- Miami Valley Hospital South
-
Centerville, Ohio, Spojené státy, 45459
- Dayton Physicians LLC-Miami Valley South
-
Cincinnati, Ohio, Spojené státy, 45220
- Good Samaritan Hospital - Cincinnati
-
Cincinnati, Ohio, Spojené státy, 45242
- Bethesda North Hospital
-
Cincinnati, Ohio, Spojené státy, 45236
- Oncology Hematology Care Inc-Kenwood
-
Cincinnati, Ohio, Spojené státy, 45247
- TriHealth Cancer Institute-Westside
-
Cincinnati, Ohio, Spojené státy, 45255
- TriHealth Cancer Institute-Anderson
-
Columbus, Ohio, Spojené státy, 43210
- Ohio State University Comprehensive Cancer Center
-
Dayton, Ohio, Spojené státy, 45409
- Miami Valley Hospital
-
Dayton, Ohio, Spojené státy, 45415
- Dayton Physician LLC-Miami Valley Hospital North
-
Dayton, Ohio, Spojené státy, 45415
- Miami Valley Hospital North
-
Dayton, Ohio, Spojené státy, 45409
- Dayton Blood and Cancer Center
-
Findlay, Ohio, Spojené státy, 45840
- Blanchard Valley Hospital
-
Findlay, Ohio, Spojené státy, 45840
- Armes Family Cancer Center
-
Findlay, Ohio, Spojené státy, 45840
- Orion Cancer Care
-
Franklin, Ohio, Spojené státy, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Franklin, Ohio, Spojené státy, 45005
- Dayton Physicians LLC-Atrium
-
Greenville, Ohio, Spojené státy, 45331
- Wayne Hospital
-
Greenville, Ohio, Spojené státy, 45331
- Dayton Physicians LLC-Wayne
-
Greenville, Ohio, Spojené státy, 45331
- Miami Valley Cancer Care and Infusion
-
Kettering, Ohio, Spojené státy, 45429
- Kettering Medical Center
-
Kettering, Ohio, Spojené státy, 45409
- Greater Dayton Cancer Center
-
Maumee, Ohio, Spojené státy, 43537
- Toledo Clinic Cancer Centers-Maumee
-
Toledo, Ohio, Spojené státy, 43623
- Toledo Clinic Cancer Centers-Toledo
-
Troy, Ohio, Spojené státy, 45373
- Upper Valley Medical Center
-
Troy, Ohio, Spojené státy, 45373
- Dayton Physicians LLC - Troy
-
Warren, Ohio, Spojené státy, 44484
- Saint Joseph Warren Hospital
-
Youngstown, Ohio, Spojené státy, 44501
- Saint Elizabeth Youngstown Hospital
-
-
Oklahoma
-
Lawton, Oklahoma, Spojené státy, 73505
- Cancer Centers of Southwest Oklahoma Research
-
Oklahoma City, Oklahoma, Spojené státy, 73104
- University of Oklahoma Health Sciences Center
-
Oklahoma City, Oklahoma, Spojené státy, 73120
- Mercy Hospital Oklahoma City
-
-
Oregon
-
Baker City, Oregon, Spojené státy, 97814
- Saint Alphonsus Medical Center-Baker City
-
Ontario, Oregon, Spojené státy, 97914
- Saint Alphonsus Medical Center-Ontario
-
-
Pennsylvania
-
Allentown, Pennsylvania, Spojené státy, 18103
- Lehigh Valley Hospital-Cedar Crest
-
Bethlehem, Pennsylvania, Spojené státy, 18017
- Lehigh Valley Hospital - Muhlenberg
-
East Stroudsburg, Pennsylvania, Spojené státy, 18301
- Pocono Medical Center
-
Hazleton, Pennsylvania, Spojené státy, 18201
- Lehigh Valley Hospital-Hazleton
-
Philadelphia, Pennsylvania, Spojené státy, 19107
- Thomas Jefferson University Hospital
-
Philadelphia, Pennsylvania, Spojené státy, 19148
- Jefferson Methodist Hospital
-
-
South Dakota
-
Sioux Falls, South Dakota, Spojené státy, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
Sioux Falls, South Dakota, Spojené státy, 57104
- Sanford Cancer Center Oncology Clinic
-
-
Texas
-
Bryan, Texas, Spojené státy, 77802
- Saint Joseph Regional Cancer Center
-
-
Virginia
-
Martinsville, Virginia, Spojené státy, 24115
- Sovah Health Martinsville
-
-
Washington
-
Bremerton, Washington, Spojené státy, 98310
- Harrison Medical Center
-
Burien, Washington, Spojené státy, 98166
- Highline Medical Center-Main Campus
-
Enumclaw, Washington, Spojené státy, 98022
- Saint Elizabeth Hospital
-
Federal Way, Washington, Spojené státy, 98003
- Saint Francis Hospital
-
Lakewood, Washington, Spojené státy, 98499
- Saint Clare Hospital
-
Tacoma, Washington, Spojené státy, 98405
- Franciscan Research Center-Northwest Medical Plaza
-
-
Wisconsin
-
Eau Claire, Wisconsin, Spojené státy, 54701
- Marshfield Medical Center-EC Cancer Center
-
Marshfield, Wisconsin, Spojené státy, 54449
- Marshfield Medical Center-Marshfield
-
Menomonee Falls, Wisconsin, Spojené státy, 53051
- Froedtert Menomonee Falls Hospital
-
Milwaukee, Wisconsin, Spojené státy, 53226
- Medical College of Wisconsin
-
Minocqua, Wisconsin, Spojené státy, 54548
- Marshfield Clinic-Minocqua Center
-
New Richmond, Wisconsin, Spojené státy, 54017
- Cancer Center of Western Wisconsin
-
Oak Creek, Wisconsin, Spojené státy, 53154
- Drexel Town Square Health Center
-
Rice Lake, Wisconsin, Spojené státy, 54868
- Marshfield Medical Center-Rice Lake
-
Stevens Point, Wisconsin, Spojené státy, 54482
- Marshfield Medical Center-River Region at Stevens Point
-
West Bend, Wisconsin, Spojené státy, 53095
- Froedtert West Bend Hospital/Kraemer Cancer Center
-
Weston, Wisconsin, Spojené státy, 54476
- Marshfield Medical Center - Weston
-
-
Wyoming
-
Cody, Wyoming, Spojené státy, 82414
- Billings Clinic-Cody
-
Sheridan, Wyoming, Spojené státy, 82801
- Welch Cancer Center
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
-
Histologic or clinical diagnosis of metastatic prostate cancer
-
Must have had evidence of metastatic disease by bone scan; or bone, nodal or visceral lesions on CT or MRI prior to starting on intense antiandrogen therapy (ADT)
- If only positron emission tomography (PET) imaging was performed prior to starting on intense ADT, then there must have been evidence of metastatic disease on the CT/MRI component (i.e. sclerotic bone lesion, non-regional lymph node >= 15 mm, and/or soft tissue lesion >= 10 mm).
- Radiographic evidence of disease is not required at the time of enrollment
- No metastases to liver or to brain, as these represent aggressive variant disease biology for which intermittent treatment may not be favored
-
Must currently be receiving intense ADT for metastatic hormone sensitive prostate cancer (mHSPC)
- Testosterone suppression (TS) with luteinizing hormone releasing hormone (LHRH)-agonist or LHRH-antagonist AND
- An approved secondary androgen receptor pathway inhibitor (ARPI) abiraterone, enzalutamide, apalutamide or darolutamide)
-
Must have remained on testosterone suppression for metastatic disease continuously (without treatment breaks) for 540-750 days (approximately 18 to 24 months) from time of first dose of LHRH agonist or antagonist by time of registration. A period of anti-androgen treatment prior to LHRH agonist or antagonist initiation is not included in the 540 - 750 days (approximately 18 to 24 months)
-
Must have received treatment with ARPI for at least 360 days in total by time of A032101 registration. Treatment breaks from the ARPI of up to 60 days are permitted (for example peri-procedural or for management of a temporary adverse event or lapse in financial coverage) as long as PSA did not rise while holding therapy and the patient has resumed for at least 30 days (without a dose hold > 72 hours within those 30 days) by time of registration. A break from ARPI longer than 60 days is permitted if a patient needed to discontinue a different ARPI for toxicity, as long as PSA did not rise while holding therapy and the patient has received at least 360 days of ARPI in total.
-
Prior TS in the context of neoadjuvant/concurrent/adjuvant treatment with local therapy is permitted. Prior course(s) of intermittent TS for biochemical-only recurrence is permitted. However, if the patient previously received TS, metastatic progression for which intense ADT was initiated must have occurred during an off-treatment interval and with testosterone >= 150 ng/dL
-
Prior local therapy for prostate cancer (either before or after diagnosis of metastatic disease) is permitted. Prior treatment with docetaxel chemotherapy for up to 6 cycles is permitted. Prior radiation therapy to metastatic sites (either for symptom palliation or for ablation of oligometastatic disease) is permitted
Exclusion Criteria:
-
No history of surgical castration
-
No history of ARPI use prior to diagnosis of mHSPC for which the patient is currently receiving intense ADT (such as in the neoadjuvant setting with prior local therapy)
-
No current or prior treatment with experimental agents for metastatic hormone-sensitive prostate cancer
-
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
-
Prior to initiating intense ADT
- PSA >= 5 ng/ml (does not need to be the most recent value prior to enrollment)
- Testosterone >= 150 ng/dl. Patients are permitted to enroll if testosterone was not measured prior to initiating intense ADT for mHSPC if they did not previously receive TS and were not known or suspected to be hypogonadal at the time
-
At time of enrollment to A032101
-
PSA < 0.2 ng/ml
** PSA values (measured in the same laboratory) must be stable or falling for 3 consecutive measurements - i.e. any PSA rise must be followed by a decrease in PSA that is further decreased or stable on a 3rd measurement. Any patient with 2 consecutive rises in PSA values since achieving castrate level of testosterone is not eligible
-
Testosterone < 50 ng/dl
-
-
No current participation in a clinical study that does not allow for TS or ARPI interruption
-
No patients with a "currently active" second malignancy * Patients with non-melanomatous skin cancer, superficial bladder cancer, cancer not needing active therapy for at least 2 years, cancer for which the treating investigator deems the subject
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Treatment (discontinue hormonal medication, follow up)
Patients stop both hormonal medications (medication to decrease testosterone levels in the body and potent oral hormonal medication to block growth signals from male hormones in the cancer cells). Patients are then followed every 12 months for symptoms. Patients with an increase in PSA level to greater than or equal to 5 ng/ml, changes on imaging studies suggesting that their cancer is growing back, or symptoms that the doctor thinks is related to their cancer growing back, resume both hormonal treatments. Patients undergo CT scans, MRI scans and bone scans prior to registration and throughout study. Patients may optionally undergo biopsies and additional collection of blood on study. |
Ancillary studies Ancillary studies Stop hormonal medications (Abiraterone, Enzalutamide, Apalutamide, Leuprolide, Goserelin, Degarelix, Relugolix)
Ostatní jména:
Undergo follow-up |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Treatment-free With Eugonadal Testosterone (>= 150 ng/dl)
Časové okno: At 18 months
|
The proportion of men who experience 18-month treatment-free interval from therapy with eugonadal testosterone (to >= 150 ng/ml) after treatment interruption will be calculated for the study cohort. |
At 18 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to Eugonadal Testosterone
Časové okno: Up to 10 years
|
The median time to eugonadal testosterone (> 150 ng/dl) will be computed by the cumulative incidence function. |
Up to 10 years
|
|
Duration Off-treatment
Časové okno: Up to 10 years
|
The median time off-treatment. |
Up to 10 years
|
|
Radiographic Progression-free Survival
Časové okno: Up to 10 years
|
The median time to radiographic progression or death (whichever occurs first) will be computed by the Kaplan-Meier estimator. |
Up to 10 years
|
|
Time to Next Treatment
Časové okno: Up to 24 months
|
The median time to the first subsequent treatment will be computed by the cumulative incidence function. |
Up to 24 months
|
|
Overall Survival
Časové okno: Assessed up to 10 years
|
The median survival time will be computed by the Kaplan-Meier estimator. Survival time defined as from treatment interruption per protocol to death due to any cause or censored at date last known alive. |
Assessed up to 10 years
|
|
Cancer-specific Survival
Časové okno: Assessed up to 10 years
|
The median survival time will be computed by the cumulative incidence function. Cancer-specific survival as defined as from treatment interruption per protocol to death attributable to cancer or its treatment in the opinion of the treating investigator or censored at date last known alive. |
Assessed up to 10 years
|
|
Non-cancer Specific Survival
Časové okno: Up to 10 years
|
The median survival time will be computed by the cumulative incidence function. Non-cancer-specific survival as defined as from treatment interruption per protocol to death not attributable to cancer or its treatment in the opinion of the treating investigator or censored at date last known alive. |
Up to 10 years
|
|
Prostate Specific Antigen (PSA) Progression-free Survival
Časové okno: Assessed up to 10 years
|
The median PSA progression free survival time will be computed by the Kaplan-Meier estimator. PSA progression free survival as defined as from treatment interruption per protocol to the first PSA failure (two consecutive increases in PSA of 25% and >= 2 ng/mL above nadir) or death. |
Assessed up to 10 years
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Atish D. Choudhury, MD, PhD, Dana-Farber Cancer Institute
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- A032101
- U10CA180821 (Grant/smlouva NIH USA)
- NCI-2021-13974 (Identifikátor registru: NCI Clinical Trial Reporting Program)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .