Sponsor:
Alliance for Clinical Trials in Oncology
Code:
NCT07200830
Conditions
Metastatic Castration-Resistant Prostate Carcinoma
Metastatic Prostate Adenocarcinoma
Stage IVB Prostate Cancer AJCC v8
Eligibility Criteria
Sex: Male
Age: 18+
Healthy Volunteers: Not accepted
Interventions
Lutetium Lu 177 Vipivotide Tetraxetan
Biospecimen Collection
Patient Monitoring
Computed Tomography
Bone Scan
Brief summary:
Conditions
Metastatic Castration-Resistant Prostate Carcinoma
Metastatic Prostate Adenocarcinoma
Stage IVB Prostate Cancer AJCC v8
Study ID
NCT07200830
Start date
Mar 31, 2026
Status verified date
Sep, 2026
Completion date
Sep 9, 2034
Anticipated
Primary completion date
Sep 9, 2034
Anticipated
Eligibility Criteria
Sex: Male
Age: 18+
Healthy Volunteers: Not accepted
Enrollment
1524 participants
Anticipated
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary purpose
Treatment
Arms
active comparator: Pre-registration step 0 (177Lu PSMA RLT)
active comparator: Randomization step 1 arm 1 (standard dose 177Lu PSMA RLT)
experimental: Randomization step 1 arm 2 (adaptive dose 177Lu PSMA RLT )
Interventions
Lutetium Lu 177 Vipivotide Tetraxetan
Biospecimen Collection
Patient Monitoring
Computed Tomography
Bone Scan
PSMA PET Scan
MRI
Questionnaire Administration
Primary outcome measure
Central contacts
Locations
Providence Alaska Medical Center
Recruiting
Anchorage, Alaska, United States, 99508
Contacts
Principal Investigator:
Alison K. Conlin
AIS Cancer Center at San Joaquin Community Hospital
Recruiting
Bakersfield, California, United States, 93301
Contacts
Site Public Contact
661-323-4673Principal Investigator:
Luis Mariscal
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Recruiting
Irvine, California, United States, 92612
Contacts
Principal Investigator:
Omid Yazdanpanah
City of Hope at Irvine Lennar
Recruiting
Irvine, California, United States, 92618
Contacts
Site Public Contact
877-467-3411Principal Investigator:
Charles B. Nguyen
Cedars-Sinai Medical Center
Recruiting
Los Angeles, California, United States, 90048
Contacts
Principal Investigator:
Edwin M. Posadas
UC Irvine Health/Chao Family Comprehensive Cancer Center
Recruiting
Orange, California, United States, 92868
Contacts
Principal Investigator:
Omid Yazdanpanah
University of California Davis Comprehensive Cancer Center
Recruiting
Sacramento, California, United States, 95817
Contacts
Site Public Contact
916-734-3089Principal Investigator:
Mamta Parikh
UCHealth Memorial Hospital Central
Recruiting
Colorado Springs, Colorado, United States, 80909
Contacts
Site Public Contact
719-365-2406Principal Investigator:
Elizabeth R. Kessler
Memorial Hospital North
Recruiting
Colorado Springs, Colorado, United States, 80920
Contacts
Site Public Contact
719-364-6700Principal Investigator:
Elizabeth R. Kessler
CTCA at Southeastern Regional Medical Center
Recruiting
Newnan, Georgia, United States, 30265
Contacts
Site Public Contact
770-400-6629Principal Investigator:
Bamidele A. Adesunloye
Kootenai Health - Coeur d'Alene
Recruiting
Coeur d'Alene, Idaho, United States, 83814
Contacts
Principal Investigator:
John M. Schallenkamp
Kootenai Clinic Cancer Services - Post Falls
Recruiting
Post Falls, Idaho, United States, 83854
Contacts
Principal Investigator:
John M. Schallenkamp
Kootenai Clinic Cancer Services - Sandpoint
Recruiting
Sandpoint, Idaho, United States, 83864
Contacts
Principal Investigator:
John M. Schallenkamp
Northwestern University
Recruiting
Chicago, Illinois, United States, 60611
Contacts
Principal Investigator:
Michael Liu
Cancer Care Specialists of Illinois - Decatur
Recruiting
Decatur, Illinois, United States, 62526
Contacts
Principal Investigator:
Bryan A. Faller
Decatur Memorial Hospital
Recruiting
Decatur, Illinois, United States, 62526
Contacts
Principal Investigator:
Bryan A. Faller
Northwestern Medicine Cancer Center Kishwaukee
Recruiting
DeKalb, Illinois, United States, 60115
Contacts
Principal Investigator:
Michael Liu
Northwestern Medicine Cancer Center Delnor
Recruiting
Geneva, Illinois, United States, 60134
Contacts
Principal Investigator:
Michael Liu
SSM Health Good Samaritan
Recruiting
Mount Vernon, Illinois, United States, 62864
Contacts
Principal Investigator:
Jay W. Carlson
Cancer Care Center of O'Fallon
Recruiting
O'Fallon, Illinois, United States, 62269
Contacts
Principal Investigator:
Bryan A. Faller
HSHS Saint Elizabeth's Hospital
Recruiting
O'Fallon, Illinois, United States, 62269
Contacts
Principal Investigator:
Bryan A. Faller
Northwestern Medicine Oak Brook
Recruiting
Oak Brook, Illinois, United States, 60523
Contacts
Site Public Contact
nctnprogram_rhlccc@northwestern.eduPrincipal Investigator:
Michael Liu
Northwestern Medicine Cancer Center Warrenville
Recruiting
Warrenville, Illinois, United States, 60555
Contacts
Principal Investigator:
Michael Liu
Midwestern Regional Medical Center
Recruiting
Zion, Illinois, United States, 60099
Contacts
Site Public Contact
844-793-0745Principal Investigator:
Walter M. Stadler
Mary Greeley Medical Center
Recruiting
Ames, Iowa, United States, 50010
Contacts
Site Public Contact
515-956-4132Principal Investigator:
Joseph J. Merchant
McFarland Clinic - Ames
Recruiting
Ames, Iowa, United States, 50010
Contacts
Principal Investigator:
Joseph J. Merchant
Iowa Methodist Medical Center
Recruiting
Des Moines, Iowa, United States, 50309
Contacts
Site Public Contact
515-241-6727Principal Investigator:
Seema Harichand-Herdt
McFarland Clinic - Trinity Cancer Center
Recruiting
Fort Dodge, Iowa, United States, 50501
Contacts
Site Public Contact
515-956-4132Principal Investigator:
Joseph J. Merchant
McFarland Clinic - Marshalltown
Recruiting
Marshalltown, Iowa, United States, 50158
Contacts
Site Public Contact
515-956-4132Principal Investigator:
Joseph J. Merchant
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Recruiting
Ann Arbor, Michigan, United States, 48106
Contacts
Principal Investigator:
Samir Narayan
Bronson Battle Creek
Recruiting
Battle Creek, Michigan, United States, 49017
Contacts
Principal Investigator:
Kathleen Y. Butler
Henry Ford Cancer Institute-Downriver
Recruiting
Brownstown, Michigan, United States, 48183
Contacts
Principal Investigator:
Clara Hwang
Henry Ford Macomb Hospital-Clinton Township
Recruiting
Clinton Township, Michigan, United States, 48038
Contacts
Principal Investigator:
Clara Hwang
Henry Ford Medical Center-Fairlane
Recruiting
Dearborn, Michigan, United States, 48126
Contacts
Principal Investigator:
Clara Hwang
Henry Ford Hospital
Recruiting
Detroit, Michigan, United States, 48202
Contacts
Principal Investigator:
Clara Hwang
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Recruiting
Grand Rapids, Michigan, United States, 49503
Contacts
Principal Investigator:
Kathleen Y. Butler
Allegiance Health
Recruiting
Jackson, Michigan, United States, 49201
Contacts
Principal Investigator:
Clara Hwang
Bronson Methodist Hospital
Recruiting
Kalamazoo, Michigan, United States, 49007
Contacts
Principal Investigator:
Kathleen Y. Butler
West Michigan Cancer Center
Recruiting
Kalamazoo, Michigan, United States, 49007
Contacts
Principal Investigator:
Kathleen Y. Butler
Corewell Health Lakeland Hospitals - Niles Hospital
Recruiting
Niles, Michigan, United States, 49120
Contacts
Site Public Contact
616-391-1230Principal Investigator:
Kathleen Y. Butler
Henry Ford Medical Center-Columbus
Recruiting
Novi, Michigan, United States, 48377
Contacts
Principal Investigator:
Clara Hwang
Corewell Health Reed City Hospital
Recruiting
Reed City, Michigan, United States, 49677
Contacts
Principal Investigator:
Kathleen Y. Butler
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Recruiting
Saint Joseph, Michigan, United States, 49085
Contacts
Principal Investigator:
Kathleen Y. Butler
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Recruiting
Saint Joseph, Michigan, United States, 49085
Contacts
Principal Investigator:
Kathleen Y. Butler
Munson Medical Center
Recruiting
Traverse City, Michigan, United States, 49684
Contacts
Principal Investigator:
Kathleen Y. Butler
Henry Ford West Bloomfield Hospital
Recruiting
West Bloomfield, Michigan, United States, 48322
Contacts
Principal Investigator:
Clara Hwang
Henry Ford Wyandotte Hospital
Recruiting
Wyandotte, Michigan, United States, 48192
Contacts
Site Public Contact
nhay@hfhs.orgPrincipal Investigator:
Clara Hwang
University of Michigan Health - West
Recruiting
Wyoming, Michigan, United States, 49519
Contacts
Principal Investigator:
Kathleen Y. Butler
Coborn Cancer Center at Saint Cloud Hospital
Recruiting
Saint Cloud, Minnesota, United States, 56303
Contacts
Principal Investigator:
Donald J. Jurgens
Heartland Regional Medical Center
Recruiting
Saint Joseph, Missouri, United States, 64506
Contacts
Principal Investigator:
Jay W. Carlson
Missouri Baptist Medical Center
Recruiting
St Louis, Missouri, United States, 63131
Contacts
Site Public Contact
314-996-5569Principal Investigator:
Bryan A. Faller
Billings Clinic Cancer Center
Recruiting
Billings, Montana, United States, 59101
Contacts
Principal Investigator:
John M. Schallenkamp
Bozeman Health Deaconess Hospital
Recruiting
Bozeman, Montana, United States, 59715
Contacts
Principal Investigator:
John M. Schallenkamp
Benefis Sletten Cancer Institute
Recruiting
Great Falls, Montana, United States, 59405
Contacts
Principal Investigator:
John M. Schallenkamp
Community Medical Center
Recruiting
Missoula, Montana, United States, 59804
Contacts
Principal Investigator:
John M. Schallenkamp
Memorial Sloan Kettering Basking Ridge
Recruiting
Basking Ridge, New Jersey, United States, 07920
Contacts
Site Public Contact
212-639-7592Principal Investigator:
Deaglan McHugh
AtlantiCare Health Park-Cape May Court House
Recruiting
Cape May Court House, New Jersey, United States, 08210
Contacts
Site Public Contact
609-677-7735Principal Investigator:
James C. Wurzer
AtlantiCare Surgery Center
Recruiting
Egg Harbor, New Jersey, United States, 08234
Contacts
Site Public Contact
609-748-7200Principal Investigator:
James C. Wurzer
Memorial Sloan Kettering Monmouth
Recruiting
Middletown, New Jersey, United States, 07748
Contacts
Site Public Contact
212-639-7592Principal Investigator:
Deaglan McHugh
Memorial Sloan Kettering Bergen
Recruiting
Montvale, New Jersey, United States, 07645
Contacts
Site Public Contact
212-639-7592Principal Investigator:
Deaglan McHugh
Capital Health Medical Center-Hopewell
Recruiting
Pennington, New Jersey, United States, 08534
Contacts
Principal Investigator:
Nikhil Thaker
Roswell Park Cancer Institute
Recruiting
Buffalo, New York, United States, 14263
Contacts
Principal Investigator:
Ellis G. Levine
Memorial Sloan Kettering Commack
Recruiting
Commack, New York, United States, 11725
Contacts
Site Public Contact
212-639-7592Principal Investigator:
Deaglan McHugh
Memorial Sloan Kettering Westchester
Recruiting
Harrison, New York, United States, 10604
Contacts
Site Public Contact
212-639-7592Principal Investigator:
Deaglan McHugh
Memorial Sloan Kettering Cancer Center
Recruiting
New York, New York, United States, 10065
Contacts
Site Public Contact
212-639-7592Principal Investigator:
Deaglan McHugh
Montefiore Medical Center-Einstein Campus
Recruiting
The Bronx, New York, United States, 10461
Contacts
Principal Investigator:
Benjamin A. Gartrell
Montefiore Medical Center - Moses Campus
Recruiting
The Bronx, New York, United States, 10467
Contacts
Principal Investigator:
Benjamin A. Gartrell
Memorial Sloan Kettering Nassau
Recruiting
Uniondale, New York, United States, 11553
Contacts
Site Public Contact
212-639-7592Principal Investigator:
Deaglan McHugh
Sanford Bismarck Medical Center
Recruiting
Bismarck, North Dakota, United States, 58501
Contacts
Principal Investigator:
Daniel Almquist
Sanford Broadway Medical Center
Recruiting
Fargo, North Dakota, United States, 58122
Contacts
Principal Investigator:
Daniel Almquist
Sanford Roger Maris Cancer Center
Recruiting
Fargo, North Dakota, United States, 58122
Contacts
Principal Investigator:
Daniel Almquist
MetroHealth Medical Center
Recruiting
Cleveland, Ohio, United States, 44109
Contacts
Principal Investigator:
Joseph Attallah
Providence Portland Medical Center
Recruiting
Portland, Oregon, United States, 97213
Contacts
Principal Investigator:
Alison K. Conlin
Providence Saint Vincent Medical Center
Recruiting
Portland, Oregon, United States, 97225
Contacts
Principal Investigator:
Alison K. Conlin
Sanford Cancer Center Oncology Clinic
Recruiting
Sioux Falls, South Dakota, United States, 57104
Contacts
Principal Investigator:
Daniel Almquist
Sanford USD Medical Center - Sioux Falls
Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contacts
Principal Investigator:
Daniel Almquist
Covenant Medical Center-Lakeside
Recruiting
Lubbock, Texas, United States, 79410
Contacts
Principal Investigator:
Gabriel Axelrud
Swedish Cancer Institute-Edmonds
Recruiting
Edmonds, Washington, United States, 98026
Contacts
Principal Investigator:
Alison K. Conlin
Swedish Medical Center-First Hill
Recruiting
Seattle, Washington, United States, 98122
Contacts
Principal Investigator:
Alison K. Conlin
Froedtert Menomonee Falls Hospital
Recruiting
Menomonee Falls, Wisconsin, United States, 53051
Contacts
Site Public Contact
262-257-5100Principal Investigator:
Kathryn A. Bylow
Medical College of Wisconsin
Recruiting
Milwaukee, Wisconsin, United States, 53226
Contacts
Site Public Contact
414-805-3666Principal Investigator:
Kathryn A. Bylow
Froedtert and MCW Moorland Reserve Health Center
Recruiting
New Berlin, Wisconsin, United States, 53151
Contacts
Site Public Contact
414-805-0505Principal Investigator:
Kathryn A. Bylow
Drexel Town Square Health Center
Recruiting
Oak Creek, Wisconsin, United States, 53154
Contacts
Site Public Contact
414-805-0505Principal Investigator:
Kathryn A. Bylow
Froedtert West Bend Hospital/Kraemer Cancer Center
Recruiting
West Bend, Wisconsin, United States, 53095
Contacts
Site Public Contact
414-805-0505Principal Investigator:
Kathryn A. Bylow
Sponsor
Alliance for Clinical Trials in Oncology
Last update posted
Sep 2, 2026
Last verified
Sep, 2026
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology on 2026-09-02.