Could a longer break between prostate cancer treatments boost quality of life?
NCT ID NCT07200830
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 5 times
Summary
This phase 3 trial for men with advanced, hormone-resistant prostate cancer tests whether giving the drug lutetium-177 PSMA less often (only when the disease shows signs of activity) can improve quality of life without shortening survival. About 1,500 participants will be randomly assigned to either the standard fixed schedule or the adaptive schedule. The goal is to see if a more personalized approach can reduce treatment burden while keeping the cancer under control.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,524 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Sep 2034
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * PRE-REGISTRATION (STEP 0): Patients must have histological, pathological, and/or cytological confirmation of prostate adenocarcinoma * PRE-REGISTRATION (STEP 0): Patients must have a positive PSMA PET/CT scan (either gallium Ga 68 gozetotide \[68Ga-PSMA-11\], fluorine F 18 piflufolastat \[18F- DCFPyl\], or fluorine F 18 flotufolastat gallium \[18F-rhPSMA-7.3\]), as defined as uptake greater than liver with no PSMA negative measurable soft tissue disease * PRE-REGISTRATION (STEP 0): PSA greater than 2.0 ng/mL * PRE-REGISTRATION (STEP 0): Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria: * Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL * Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions * Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 Prostate Cancer Clinical Trials Working Group 3 \[PCWG3\] criteria, Scher et al 2016) * PRE-REGISTRATION (STEP 0): Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L) * PRE-REGISTRATION (STEP 0): Patients must have received at least one androgen receptor pathway inhibitor (ARPI) (to include either apalutamide, darolutamide, enzalutamide, or abiraterone) \* ARPI must be stopped at least 4 weeks prior to pre-registration * PRE-REGISTRATION (STEP 0): Patients must not have previously received a taxane based chemotherapy regimen for mCRPC. Prior docetaxel for metastatic hormone-sensitive prostate carcinoma (mHSPC) or in the neoadjuvant or adjuvant setting is permitted if completed at least 12 months prior to pre-registration * PRE-REGISTRATION (STEP 0): Patients must have recovered to ≤ grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.) * PRE-REGISTRATION (STEP 0): Patients on a stable bisphosphonate or denosumab regimen for ≥ 30 days prior to pre-registration are eligible * PRE-REGISTRATION (STEP 0): Previous treatment with strontium Sr-89 (strontium-89), samarium Sm-153 (samarium-153), rhenium Re 186 (rhenium-186), rhenium Re 188 (rhenium-188), radium Ra 223 (radium-223) or hemi-body irradiation within 6 months prior to pre-registration is not allowed. Previous PSMA-targeted radioligand therapy is not allowed * PRE-REGISTRATION (STEP 0): Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \[including monoclonal antibodies\]) within 28 days prior to pre-registration is not allowed * PRE-REGISTRATION (STEP 0): Age ≥ 18 years * PRE-REGISTRATION (STEP 0): Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 * PRE-REGISTRATION (STEP 0): Absolute neutrophil count (ANC) ≥ 1,500/mm\^3 * PRE-REGISTRATION (STEP 0): Platelet count ≥ 100,000/mm\^3 * PRE-REGISTRATION (STEP 0): Total bilirubin \< 1.5 x upper limit of normal (ULN) or \< 3 x ULN in patients with Gilbert's syndrome * PRE-REGISTRATION (STEP 0): Creatinine clearance estimated glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73m\^2 using the Modification of Diet in Renal Disease (MDRD) equation * PRE-REGISTRATION (STEP 0): No acute biliary or urinary obstruction * PRE-REGISTRATION (STEP 0): Patients with treated/stable brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression \* Patients with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast) * PRE-REGISTRATION (STEP 0): 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 * PRE-REGISTRATION (STEP 0): For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * PRE-REGISTRATION (STEP 0): 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 * PRE-REGISTRATION (STEP 0): 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 * PRE-REGISTRATION (STEP 0): No investigational agents within 28 days prior to pre-registration * PRE-REGISTRATION (STEP 0): No other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy * PRE-REGISTRATION (STEP 0): No known hypersensitivity to the components of the study therapy or its analogs * PRE-REGISTRATION (STEP 0): No transfusion within 30 days of pre-registration * PRE-REGISTRATION (STEP 0): No symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression * PRE-REGISTRATION (STEP 0): Ability to read and comprehend English or Spanish * REGISTRATION (STEP 1): Completion of 2 doses of 177Lu PSMA RLT * REGISTRATION (STEP 1): PSA decline ≥ 50% between C1 D1 (screening) and C2 D22 +/-3 days * REGISTRATION (STEP 1): ECOG Performance Status ≤ 2 * REGISTRATION (STEP 1): Absolute neutrophil count (ANC) ≥ 1,500/mm\^3 * REGISTRATION (STEP 1): Platelet count ≥ 100,000/mm\^3 * REGISTRATION (STEP 1): Creatinine clearance eGFR ≥ 40 mL/min/1.73m\^2 using the Modification of Diet in Renal Disease (MDRD) equation
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metastatic castration-resistant prostate carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
129 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
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AIS Cancer Center at San Joaquin Community Hospital
RECRUITINGBakersfield, California, 93301, United States
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Abbott-Northwestern Hospital
SUSPENDEDMinneapolis, Minnesota, 55407, United States
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Allegiance Health
RECRUITINGJackson, Michigan, 49201, United States
Contact Email: •••••@•••••
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AtlantiCare Health Park-Cape May Court House
RECRUITINGCape May Court House, New Jersey, 08210, United States
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AtlantiCare Surgery Center
RECRUITINGEgg Harbor, New Jersey, 08234, United States
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Benefis Helena Specialty Center
SUSPENDEDHelena, Montana, 59601, United States
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Benefis Sletten Cancer Institute
RECRUITINGGreat Falls, Montana, 59405, United States
Contact Email: •••••@•••••
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Billings Clinic Cancer Center
RECRUITINGBillings, Montana, 59101, United States
Contact Email: •••••@•••••
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Billings Clinic-Cody
SUSPENDEDCody, Wyoming, 82414, United States
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Bozeman Health Deaconess Hospital
RECRUITINGBozeman, Montana, 59715, United States
Contact Email: •••••@•••••
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Broadlawns Medical Center
SUSPENDEDDes Moines, Iowa, 50314, United States
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Bronson Battle Creek
RECRUITINGBattle Creek, Michigan, 49017, United States
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Bronson Methodist Hospital
RECRUITINGKalamazoo, Michigan, 49007, United States
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CTCA at Southeastern Regional Medical Center
RECRUITINGNewnan, Georgia, 30265, United States
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Cambridge Medical Center
SUSPENDEDCambridge, Minnesota, 55008, United States
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Cancer Care Center of O'Fallon
RECRUITINGO'Fallon, Illinois, 62269, United States
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Cancer Care Specialists of Illinois - Decatur
RECRUITINGDecatur, Illinois, 62526, United States
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Cancer Center of Western Wisconsin
SUSPENDEDNew Richmond, Wisconsin, 54017, United States
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Capital Health Medical Center-Hopewell
RECRUITINGPennington, New Jersey, 08534, United States
Contact Email: •••••@•••••
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Cedars-Sinai Medical Center
RECRUITINGLos Angeles, California, 90048, United States
Contact Email: •••••@•••••
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City of Hope at Irvine Lennar
RECRUITINGIrvine, California, 92618, United States
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Coborn Cancer Center at Saint Cloud Hospital
RECRUITINGSaint Cloud, Minnesota, 56303, United States
Contact Email: •••••@•••••
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Community Hospital of Anaconda
SUSPENDEDAnaconda, Montana, 59711, United States
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Community Medical Center
RECRUITINGMissoula, Montana, 59804, United States
Contact Email: •••••@•••••
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Corewell Health Grand Rapids Hospitals - Butterworth Hospital
RECRUITINGGrand Rapids, Michigan, 49503, United States
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Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
RECRUITINGSaint Joseph, Michigan, 49085, United States
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Corewell Health Lakeland Hospitals - Niles Hospital
RECRUITINGNiles, Michigan, 49120, United States
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Corewell Health Lakeland Hospitals - Saint Joseph Hospital
RECRUITINGSaint Joseph, Michigan, 49085, United States
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Corewell Health Reed City Hospital
RECRUITINGReed City, Michigan, 49677, United States
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Covenant Medical Center-Lakeside
RECRUITINGLubbock, Texas, 79410, United States
Contact Email: •••••@•••••
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Decatur Memorial Hospital
RECRUITINGDecatur, Illinois, 62526, United States
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Drexel Town Square Health Center
RECRUITINGOak Creek, Wisconsin, 53154, United States
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Fairview Clinics and Surgery Center Maple Grove
SUSPENDEDMaple Grove, Minnesota, 55369, United States
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Fairview Lakes Medical Center
SUSPENDEDWyoming, Minnesota, 55092, United States
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Fairview Northland Medical Center
SUSPENDEDPrinceton, Minnesota, 55371, United States
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Fairview Southdale Hospital
SUSPENDEDEdina, Minnesota, 55435, United States
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Froedtert Menomonee Falls Hospital
RECRUITINGMenomonee Falls, Wisconsin, 53051, United States
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Froedtert West Bend Hospital/Kraemer Cancer Center
RECRUITINGWest Bend, Wisconsin, 53095, United States
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Froedtert and MCW Moorland Reserve Health Center
RECRUITINGNew Berlin, Wisconsin, 53151, United States
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Great Falls Clinic
SUSPENDEDGreat Falls, Montana, 59405, United States
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HSHS Saint Elizabeth's Hospital
RECRUITINGO'Fallon, Illinois, 62269, United States
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Heartland Regional Medical Center
RECRUITINGSaint Joseph, Missouri, 64506, United States
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Helen F Graham Cancer Center
SUSPENDEDNewark, Delaware, 19713, United States
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Hennepin County Medical Center
SUSPENDEDMinneapolis, Minnesota, 55415, United States
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Henry Ford Cancer Institute-Downriver
RECRUITINGBrownstown, Michigan, 48183, United States
Contact Email: •••••@•••••
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Henry Ford Hospital
RECRUITINGDetroit, Michigan, 48202, United States
Contact Email: •••••@•••••
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Henry Ford Macomb Hospital-Clinton Township
RECRUITINGClinton Township, Michigan, 48038, United States
Contact Email: •••••@•••••
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Henry Ford Medical Center-Columbus
RECRUITINGNovi, Michigan, 48377, United States
Contact Email: •••••@•••••
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Henry Ford Medical Center-Fairlane
RECRUITINGDearborn, Michigan, 48126, United States
Contact Email: •••••@•••••
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Henry Ford West Bloomfield Hospital
RECRUITINGWest Bloomfield, Michigan, 48322, United States
Contact Email: •••••@•••••
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Henry Ford Wyandotte Hospital
RECRUITINGWyandotte, Michigan, 48192, United States
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Hi-Line Sletten Cancer Center
SUSPENDEDHavre, Montana, 59501, United States
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Iowa Methodist Medical Center
RECRUITINGDes Moines, Iowa, 50309, United States
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Kootenai Clinic Cancer Services - Post Falls
RECRUITINGPost Falls, Idaho, 83854, United States
Contact Email: •••••@•••••
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Kootenai Clinic Cancer Services - Sandpoint
RECRUITINGSandpoint, Idaho, 83864, United States
Contact Email: •••••@•••••
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Kootenai Health - Coeur d'Alene
RECRUITINGCoeur d'Alene, Idaho, 83814, United States
Contact Email: •••••@•••••
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Lakeview Hospital
SUSPENDEDStillwater, Minnesota, 55082, United States
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Logan Health Medical Center
SUSPENDEDKalispell, Montana, 59901, United States
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Mary Greeley Medical Center
RECRUITINGAmes, Iowa, 50010, United States
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McFarland Clinic - Ames
RECRUITINGAmes, Iowa, 50010, United States
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McFarland Clinic - Boone
SUSPENDEDBoone, Iowa, 50036, United States
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McFarland Clinic - Jefferson
SUSPENDEDJefferson, Iowa, 50129, United States
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McFarland Clinic - Marshalltown
RECRUITINGMarshalltown, Iowa, 50158, United States
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McFarland Clinic - Trinity Cancer Center
RECRUITINGFort Dodge, Iowa, 50501, United States
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Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Medical Oncology Hematology Consultants PA
SUSPENDEDNewark, Delaware, 19713, United States
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Memorial Hospital North
RECRUITINGColorado Springs, Colorado, 80920, United States
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Memorial Hospital of Laramie County
SUSPENDEDCheyenne, Wyoming, 82001, United States
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Memorial Sloan Kettering Basking Ridge
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Commack
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
RECRUITINGHarrison, New York, 10604, United States
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Mercy Hospital
SUSPENDEDCoon Rapids, Minnesota, 55433, United States
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MetroHealth Medical Center
RECRUITINGCleveland, Ohio, 44109, United States
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Midwestern Regional Medical Center
RECRUITINGZion, Illinois, 60099, United States
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Minnesota Oncology - Burnsville
SUSPENDEDBurnsville, Minnesota, 55337, United States
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Minnesota Oncology Hematology PA-Maplewood
SUSPENDEDMaplewood, Minnesota, 55109, United States
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Minnesota Oncology Hematology PA-Woodbury
SUSPENDEDWoodbury, Minnesota, 55125, United States
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Missouri Baptist Medical Center
RECRUITINGSt Louis, Missouri, 63131, United States
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Montefiore Medical Center - Moses Campus
RECRUITINGThe Bronx, New York, 10467, United States
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Montefiore Medical Center-Einstein Campus
RECRUITINGThe Bronx, New York, 10461, United States
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Munson Medical Center
RECRUITINGTraverse City, Michigan, 49684, United States
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New Ulm Medical Center
SUSPENDEDNew Ulm, Minnesota, 56073, United States
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North Memorial Medical Health Center
SUSPENDEDRobbinsdale, Minnesota, 55422, United States
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Northwestern Medicine Cancer Center Delnor
RECRUITINGGeneva, Illinois, 60134, United States
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Northwestern Medicine Cancer Center Kishwaukee
RECRUITINGDeKalb, Illinois, 60115, United States
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Northwestern Medicine Cancer Center Warrenville
RECRUITINGWarrenville, Illinois, 60555, United States
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Northwestern Medicine Oak Brook
RECRUITINGOak Brook, Illinois, 60523, United States
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Northwestern University
RECRUITINGChicago, Illinois, 60611, United States
Contact Email: •••••@•••••
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Park Nicollet Clinic - Saint Louis Park
SUSPENDEDSaint Louis Park, Minnesota, 55416, United States
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Providence Alaska Medical Center
RECRUITINGAnchorage, Alaska, 99508, United States
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Providence Portland Medical Center
RECRUITINGPortland, Oregon, 97213, United States
Contact Email: •••••@•••••
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Providence Saint Vincent Medical Center
RECRUITINGPortland, Oregon, 97225, United States
Contact Email: •••••@•••••
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Regions Hospital
SUSPENDEDSaint Paul, Minnesota, 55101, United States
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Rice Memorial Hospital
SUSPENDEDWillmar, Minnesota, 56201, United States
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Ridgeview Medical Center
SUSPENDEDWaconia, Minnesota, 55387, United States
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Roswell Park Cancer Institute
RECRUITINGBuffalo, New York, 14263, United States
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SSM Health Good Samaritan
RECRUITINGMount Vernon, Illinois, 62864, United States
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Saint Anthony Regional Hospital
SUSPENDEDCarroll, Iowa, 51401, United States
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Saint Francis Regional Medical Center
SUSPENDEDShakopee, Minnesota, 55379, United States
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Saint John's Hospital - Healtheast
SUSPENDEDMaplewood, Minnesota, 55109, United States
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Sanford Bismarck Medical Center
RECRUITINGBismarck, North Dakota, 58501, United States
Contact Email: •••••@•••••
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Sanford Broadway Medical Center
RECRUITINGFargo, North Dakota, 58122, United States
Contact Email: •••••@•••••
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Sanford Cancer Center Oncology Clinic
RECRUITINGSioux Falls, South Dakota, 57104, United States
Contact Email: •••••@•••••
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Sanford Roger Maris Cancer Center
RECRUITINGFargo, North Dakota, 58122, United States
Contact Email: •••••@•••••
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Sanford USD Medical Center - Sioux Falls
RECRUITINGSioux Falls, South Dakota, 57117-5134, United States
Contact Email: •••••@•••••
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Swedish Cancer Institute-Edmonds
RECRUITINGEdmonds, Washington, 98026, United States
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Swedish Medical Center-First Hill
RECRUITINGSeattle, Washington, 98122, United States
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The Iowa Clinic PC
SUSPENDEDWest Des Moines, Iowa, 50266, United States
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Trinity Health Saint Joseph Mercy Hospital Ann Arbor
RECRUITINGAnn Arbor, Michigan, 48106, United States
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Trinity Health Saint Joseph Mercy Oakland Hospital
SUSPENDEDPontiac, Michigan, 48341, United States
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UC Irvine Health/Chao Family Comprehensive Cancer Center
RECRUITINGOrange, California, 92868, United States
Contact Email: •••••@•••••
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UCHealth Memorial Hospital Central
RECRUITINGColorado Springs, Colorado, 80909, United States
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UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
RECRUITINGIrvine, California, 92612, United States
Contact Email: •••••@•••••
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UI Health Care Mission Cancer and Blood - Ankeny Clinic
SUSPENDEDAnkeny, Iowa, 50023, United States
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UI Health Care Mission Cancer and Blood - Des Moines Clinic
SUSPENDEDDes Moines, Iowa, 50309, United States
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UI Health Care Mission Cancer and Blood - Laurel Clinic
SUSPENDEDDes Moines, Iowa, 50314, United States
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UI Health Care Mission Cancer and Blood - Waukee Clinic
SUSPENDEDWaukee, Iowa, 50263, United States
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UI Health Care Mission Cancer and Blood - West Des Moines Clinic
SUSPENDEDClive, Iowa, 50325, United States
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UI Healthcare Mission Cancer and Blood - Fort Dodge
SUSPENDEDFort Dodge, Iowa, 50501, United States
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UI Healthcare Mission Cancer and Blood - Pella
SUSPENDEDPella, Iowa, 50219, United States
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United Hospital
SUSPENDEDSaint Paul, Minnesota, 55102, United States
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University of California Davis Comprehensive Cancer Center
RECRUITINGSacramento, California, 95817, United States
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University of Michigan Health - West
RECRUITINGWyoming, Michigan, 49519, United States
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University of Oklahoma Health Sciences Center
SUSPENDEDOklahoma City, Oklahoma, 73104, United States
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West Michigan Cancer Center
RECRUITINGKalamazoo, Michigan, 49007, United States
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