Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

Phase 3

Recruiting

• Conditions: Prostate Cancer Metastatic
• Interventions: Drug: Opevesostat; Drug: Abiraterone acetate; Drug: Hydrocortisone; Drug: Enzalutamide; Drug: Fludrocortisone acetate; Drug: Prednisone; Drug: Dexamethasone

• Registration Number: NCT06136624
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) and to radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria In Solid Tumors (RECIST 1.1) as assessed by blinded independent central review (BICR) in participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy. It is hypothesized that opevesostat is superior with respect to OS and rPFS per PCWG Modified RECIST 1.1 as assessed by BICR in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-13
• Study First Posted: 2023-11-18
• Study Start: 2023-12-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16
• Primary Completion: 2028-08-02
• Study Completion: 2028-08-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology.
• Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening
• Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI).
• Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA)
• Has received 1 but no more than 2 taxane-based chemotherapy regimens for metastatic castration-resistant prostate cancer (mCRPC) and has had progressive disease (PD) during or after treatment
• Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nM)
• Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
• Has had prior treatment with PARPi or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
• Has received prior 177Lu-PSMA-617 or were deemed ineligible to receive 177Lu-PSMA-617 treatment by the investigator or refused 177Lu-PSMA-617 treatment
• Participants who have not received cabazitaxel can be enrolled if they are ineligible for cabazitaxel treatment as determined by the investigator or have refused treatment
• If participant received first generation anti-androgen therapy before screening, the participant has evidence of disease progression >4 weeks since the last flutamide treatment and >6 weeks since the last bicalutamide or nilutamide treatment
• Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for ≥ 4 weeks before the date of randomization
• Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on antiretroviral therapy (ART)
• Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening.
• Participants who can produce sperm must agree to the following during the study treatment period and for at least 7 days after the last dose of opevesostat, for at least 30 days after the last dose of abiraterone acetate, and for at least 3 months after the last dose of enzalutamide: EITHER be abstinent OR must agree to use male condom

Exclusion Criteria

• Has a gastrointestinal disorder that might affect absorption
• Has a history of pituitary dysfunction
• Has poorly controlled diabetes mellitus
• Has clinically significant abnormal serum potassium or sodium level
• Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events
• Has a history of seizure within 6 months of providing documented informed consent or any condition that may predispose to seizures within 12 months before the date of randomization
• Has a history of clinically significant ventricular arrhythmias
• Has received an anticancer monoclonal antibody (mAb) within 4 weeks before the date of randomization, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of randomization
• Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization, and has not recovered from the toxicities and/or complications
• Participants who have not adequately recovered from major surgery or have ongoing surgical complications
• Has used herbal or medicinal products that may have hormonal anti-prostate cancer activity and/or are known to decrease prostate-specific Antigen (PSA) (eg, saw palmetto, megesterol acetate) within 4 weeks before the date of randomization
• Has received radium-223 or lutetium-177 within 4 weeks before the date of randomization, or has not recovered to Grade ≤1 or baseline from AEs due to radium-223 or lutetium-177 administered more than 4 weeks before the date of randomization
• Has received treatment with 5-αreductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization
• Has received colony-stimulating factors within 28 days before the date of randomization
• Has received a whole blood transfusion in the last 120 days before the date of randomization. Packed red blood cells and platelet transfusions are acceptable if not given within 28 days of the date of randomization
• Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate + prednisone or darolutamide within 2 weeks
• Has a "superscan" bone scan
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has an active autoimmune disease that has required systemic treatment in past 2 years
• Has an active infection requiring systemic therapy
• Has concurrent active HBV or known active HCV infection
• Has a history of long QTc syndrome
• Has any of the following at Screening Visit: hypotension (systolic BP <110 mm Hg) or uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg, in 2 out of 3 recordings with optimized antihypertensive therapy)
• Is unable to swallow capsules/tablets
• Is currently being treated with cytochrome 450-inducing antiepileptic drugs for seizures
• Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention
• Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
• Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
• Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
• Systemic use of the following medications within 2 weeks before the first dose of study intervention: strong CYP3A4 inducers (eg, avasimibe, carbamazepine, lumacaftor, phenobarbital, rifampicin, rifapentine, or St John's Wort); P-gp inhibitors (eg, erythromycin, clarithromycin, rifampicin, ketoconazole, itraconazole, posaconazole, artesunate-pyronaridine, ritonavir, indinavir, nelfinavir, atazanavir, glecaprevir-pibrentasvir, simeprevir, ledipasvir-sofosbuvir, verapamil, diltiazem, dronedarone, propafenone, quinidine, cyclosporine, valspodar, or milk thistle [Silybum marianum])
• Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opevesostat	Hydrocortisone	Participants receive opevesostat 5 mg by oral tablets twice daily (bid) plus dexamethasone 1.5 mg by oral tablets once daily (qd) and 0.1 mg fludrocortisone acetate by oral tablet qd until progression. Hydrocortisone 100 mg (oral or intramuscular \[IM\]) dose will also be provided to participants for use as rescue medication.
Opevesostat	Fludrocortisone acetate	Participants receive opevesostat 5 mg by oral tablets twice daily (bid) plus dexamethasone 1.5 mg by oral tablets once daily (qd) and 0.1 mg fludrocortisone acetate by oral tablet qd until progression. Hydrocortisone 100 mg (oral or intramuscular \[IM\]) dose will also be provided to participants for use as rescue medication.
Opevesostat	Dexamethasone	Participants receive opevesostat 5 mg by oral tablets twice daily (bid) plus dexamethasone 1.5 mg by oral tablets once daily (qd) and 0.1 mg fludrocortisone acetate by oral tablet qd until progression. Hydrocortisone 100 mg (oral or intramuscular \[IM\]) dose will also be provided to participants for use as rescue medication.
Abiraterone Acetate or Enzalutamide	Enzalutamide	Participants receive abiraterone 1000 mg qd by oral tablets plus prednisone 5 mg bid by oral tablets or enzalutamide 160 mg qd by oral tablets.
Opevesostat	Opevesostat	Participants receive opevesostat 5 mg by oral tablets twice daily (bid) plus dexamethasone 1.5 mg by oral tablets once daily (qd) and 0.1 mg fludrocortisone acetate by oral tablet qd until progression. Hydrocortisone 100 mg (oral or intramuscular \[IM\]) dose will also be provided to participants for use as rescue medication.
Abiraterone Acetate or Enzalutamide	Prednisone	Participants receive abiraterone 1000 mg qd by oral tablets plus prednisone 5 mg bid by oral tablets or enzalutamide 160 mg qd by oral tablets.
Abiraterone Acetate or Enzalutamide	Abiraterone acetate	Participants receive abiraterone 1000 mg qd by oral tablets plus prednisone 5 mg bid by oral tablets or enzalutamide 160 mg qd by oral tablets.

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS) in Androgen Receptor Ligand Binding Domain (AR LBD) Mutation-Positive Participants	Up to ~54 months	OS is defined as time from randomization to death due to any cause. OS in AR LBD mutation-positive participants will be reported for each study arm.
OS in AR LBD Mutation-Negative Participants	Up to ~54 months	OS is defined as time from randomization to death due to any cause. OS in AR LBD mutation-negative participants will be reported for each study arm.
Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review in AR LBD Mutation-Positive Participant	Up to ~36 months	rPFS is defined as the time from randomization to the first documented disease progression per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first. rPFS in AR LBD mutation-positive participants will be reported for each study arm.
rPFS Per Prostate Cancer Working Group-modified RECIST 1.1 as Assessed by Blinded Independent Central Review in AR LBD Mutation-Negative Participants	Up to ~36 months	rPFS is defined as the time from randomization to the first documented disease progression per PCWG-modified RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first. rPFS in AR LBD mutation-negative participants will be reported for each study arm.

Secondary Outcome Measures

Name	Time	Method
Time to Initiation of the First Subsequent Anti-Cancer Therapy or Death (TFST)	Up to ~54 months	TFST is defined as the time from randomization to initiation of the first subsequent anticancer therapy or death, whichever occurs first.
Objective Response (OR)	Up to ~54 months	OR is determined by PCWG-modified RECIST 1.1 as assessed by BICR.
Duration of Response (DOR)	Up to ~54 months	DOR is determined by PCWG-modified RECIST 1.1 as assessed by BICR.
Time to Pain Progression (TTPP)	Up to ~54 months	TTPP is assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and opiate analgesic use (Analgesic Quantification Algorithm \[AQA\] Score).
Time to Prostate-specific Antigen (PSA) Progression	Up to ~54 months	The time from randomization to PSA progression. The PSA progression date is defined as the date of either: 1) ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there is PSA decline from baseline 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline.
Time to First Symptomatic Skeletal-related Event (SSRE)	Up to ~54 months	The time from randomization to the first occurrence of any of the following symptomatic skeletal-related events: 1) Use of EBRT to prevent or relieve skeletal symptoms; 2) new symptomatic pathologic bone fracture (vertebral or nonvertebral); 3) spinal cord compression; or 4) tumor-related orthopedic surgical intervention.
Number of Participants Who Experience an Adverse Event	Up to ~54 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event	Up to ~54 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Trial Locations

Locations (279)

Aliada-Oncologìa ( Site 1257); 🇵🇪 Lima, Peru

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040); 🇺🇸 Orange, California, United States

Stanford Cancer Center ( Site 0036); 🇺🇸 Palo Alto, California, United States

Kaiser Permanente Riverside Medical Center ( Site 0099); 🇺🇸 Riverside, California, United States

Anschutz Cancer Pavilion ( Site 0046); 🇺🇸 Aurora, Colorado, United States

University of Colorado Health - Highlands Ranch Hospital ( Site 0111); 🇺🇸 Highlands Ranch, Colorado, United States

Colorado Clinical Research ( Site 0067); 🇺🇸 Lakewood, Colorado, United States

University of Colorado Health - Lone Tree Medical Center ( Site 0112); 🇺🇸 Lone Tree, Colorado, United States

Yale-New Haven Hospital-Yale Cancer Center ( Site 0064); 🇺🇸 New Haven, Connecticut, United States

Florida Cancer Specialists - South ( Site 7003); 🇺🇸 Fort Myers, Florida, United States

Bruce W. Carter Veterans Affairs Medical Center ( Site 0082); 🇺🇸 Miami, Florida, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0051); 🇺🇸 Miami, Florida, United States

University of Illinois at Chicago ( Site 0105); 🇺🇸 Chicago, Illinois, United States

University of Chicago Medical Center ( Site 0045); 🇺🇸 Chicago, Illinois, United States

University of Iowa ( Site 0047); 🇺🇸 Iowa City, Iowa, United States

University of Kentucky Chandler Medical Center ( Site 0048); 🇺🇸 Lexington, Kentucky, United States

Ochsner Clinic Foundation ( Site 0108); 🇺🇸 New Orleans, Louisiana, United States

Baltimore Veterans Affairs Medical Center ( Site 0069); 🇺🇸 Baltimore, Maryland, United States

Greenebaum Comprehensive Cancer Center ( Site 0049); 🇺🇸 Baltimore, Maryland, United States

Henry Ford Hospital ( Site 0015); 🇺🇸 Detroit, Michigan, United States

M Health Fairview Clinics and Surgery Center ( Site 0019); 🇺🇸 Minneapolis, Minnesota, United States

Metro-Minnesota Community Clinical Oncology ( Site 0014); 🇺🇸 Saint Louis Park, Minnesota, United States

Washington University School of Medicine-Internal Medicine/Oncology ( Site 0062); 🇺🇸 Saint Louis, Missouri, United States

University Of Nebraska Medical Center-Oncology/Hematology ( Site 0095); 🇺🇸 Omaha, Nebraska, United States

Comprehensive Cancer Centers of Nevada ( Site 0010); 🇺🇸 Las Vegas, Nevada, United States

Atlantic Health System Morristown Medical Center ( Site 0115); 🇺🇸 Morristown, New Jersey, United States

Rutgers Cancer Institute of New Jersey ( Site 0033); 🇺🇸 New Brunswick, New Jersey, United States

James J. Peters VA Medical Center ( Site 0088); 🇺🇸 Bronx, New York, United States

University Hospitals Cleveland Medical Center ( Site 0043); 🇺🇸 Cleveland, Ohio, United States

Oregon Health and Science University ( Site 0028); 🇺🇸 Portland, Oregon, United States

VA Portland Health Care System ( Site 0058); 🇺🇸 Portland, Oregon, United States

AHN Allegheny General Hospital ( Site 0001); 🇺🇸 Pittsburgh, Pennsylvania, United States

Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083); 🇺🇸 Charleston, South Carolina, United States

Avera Cancer Institute - Pierre ( Site 0118); 🇺🇸 Pierre, South Dakota, United States

Avera Cancer Institute- Research ( Site 0094); 🇺🇸 Sioux Falls, South Dakota, United States

Avera Cancer Institute - Yankton ( Site 0117); 🇺🇸 Yankton, South Dakota, United States

SCRI Oncology Partners ( Site 7000); 🇺🇸 Nashville, Tennessee, United States

Texas Oncology - Central/South Texas ( Site 8003); 🇺🇸 Austin, Texas, United States

University of Virginia Health System ( Site 0054); 🇺🇸 Charlottesville, Virginia, United States

VCU Health Adult Outpatient Pavillion ( Site 0061); 🇺🇸 Richmond, Virginia, United States

Blue Ridge Cancer Care ( Site 0004); 🇺🇸 Roanoke, Virginia, United States

Fred Hutchinson Cancer Center ( Site 0013); 🇺🇸 Seattle, Washington, United States

MEDICAL COLLEGE OF WISCONSIN ( Site 0020); 🇺🇸 Milwaukee, Wisconsin, United States

Hospital Británico de Buenos Aires-Oncology ( Site 0202); 🇦🇷 Ciudad autónoma de Buenos Aires, Buenos Aires, Argentina

Texas Oncology - DFW ( Site 8001); 🇺🇸 Dallas, Texas, United States

Texas Oncology - Gulf Coast ( Site 8002); 🇺🇸 Houston, Texas, United States

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201); 🇦🇷 Mar del Plata, Buenos Aires, Argentina

Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205); 🇦🇷 Buenos Aires, Caba, Argentina

Instituto Alexander Fleming-Alexander Fleming ( Site 0206); 🇦🇷 Ciudad Autónoma de Buenos Aires, Caba, Argentina

Sanatorio Parque ( Site 0208); 🇦🇷 Rosario, Santa Fe, Argentina

Hospital Aleman-Oncology ( Site 0207); 🇦🇷 Buenos Aires, Argentina

Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0204); 🇦🇷 Mendoza, Argentina

Dubbo Hospital ( Site 0235); 🇦🇺 Dubbo, New South Wales, Australia

Macquarie University-MQ Health Clinical Trials Unit ( Site 0234); 🇦🇺 Macquarie University, New South Wales, Australia

Westmead Hospital ( Site 0232); 🇦🇺 Westmead, New South Wales, Australia

Princess Alexandra Hospital-Cancer Care Serices ( Site 0237); 🇦🇺 Brisbane, Queensland, Australia

Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0230); 🇦🇺 Melbourne, Victoria, Australia

Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0276); 🇦🇹 Linz, Oberosterreich, Austria

Klinikum Wels-Grieskirchen GmbH ( Site 0279); 🇦🇹 Wels, Oberosterreich, Austria

Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0280); 🇦🇹 Graz, Steiermark, Austria

Obras Sociais Irma Dulce ( Site 0302); 🇧🇷 Salvador, Bahia, Brazil

Hospital Santa Rita de Cassia-Centro de Pesquisa Clínica ( Site 0320); 🇧🇷 Vitoria, Espirito Santo, Brazil

Hospital Felicio Rocho ( Site 0317); 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Hospital Mario Penna ( Site 0309); 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Hospital Universitário Evangélico Mackenzie-Centro de Oncologia Mackenzie ( Site 0314); 🇧🇷 Curitiba, Parana, Brazil

Clínica de Neoplasias Litoral ( Site 0305); 🇧🇷 Itajai, Santa Catarina, Brazil

Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0308); 🇧🇷 Bragança Paulista, Sao Paulo, Brazil

A. C. Camargo Cancer Center ( Site 0310); 🇧🇷 São Paulo, Sao Paulo, Brazil

Cross Cancer Institute ( Site 0332); 🇨🇦 Edmonton, Alberta, Canada

The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0336); 🇨🇦 Ottawa, Ontario, Canada

Sunnybrook Research Institute ( Site 0331); 🇨🇦 Toronto, Ontario, Canada

Princess Margaret Cancer Centre ( Site 0330); 🇨🇦 Toronto, Ontario, Canada

Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0328); 🇨🇦 Greenfield Park, Quebec, Canada

Centre Hospitalier de l'Université de Montréal ( Site 0326); 🇨🇦 Montréal, Quebec, Canada

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0327); 🇨🇦 Quebec City, Quebec, Canada

Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0329); 🇨🇦 Sherbrooke, Quebec, Canada

IC La Serena Research ( Site 0356); 🇨🇱 La Serena., Coquimbo, Chile

Clinical Research Chile SpA ( Site 0358); 🇨🇱 Valdivia, Los Rios, Chile

Clinica Universidad Catolica del Maule-Oncology ( Site 0355); 🇨🇱 Talca, Maule, Chile

FALP ( Site 0353); 🇨🇱 Santiago, Region M. De Santiago, Chile

Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0354); 🇨🇱 Santiago, Region M. De Santiago, Chile

Bradfordhill-Clinical Area ( Site 0351); 🇨🇱 Santiago, Region M. De Santiago, Chile

Bradford Hill Norte ( Site 0357); 🇨🇱 Antofagasta, Chile

Second Affiliated hospital of Anhui Medical University-Urology ( Site 0408); 🇨🇳 Hefei, Anhui, China

Peking University First Hospital-Urology ( Site 0390); 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hospital Affiliate of Capital University ( Site 0396); 🇨🇳 Beijing, Beijing, China

Beijing Cancer hospital-Urinary Surgery ( Site 0395); 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Chongqing Medical University ( Site 0427); 🇨🇳 Chongqing, Chongqing, China

Chongqing University Cancer Hospital ( Site 0416); 🇨🇳 Chongqing, Chongqing, China

Southwest Hospital of Third Military Medical University ( Site 0420); 🇨🇳 Chongqing, Chongqing, China

Chongqing Three Gorges Central Hospital's ( Site 0426); 🇨🇳 Chongqing, Chongqing, China

The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 0414); 🇨🇳 Fuzhou, Fujian, China

The First Affiliated hospital of Xiamen University-Urology ( Site 0415); 🇨🇳 Xiamen, Fujian, China

The First Affiliated Hospital of Guangzhou Medical University ( Site 0412); 🇨🇳 Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center-Internal medicine ( Site 0413); 🇨🇳 Guangzhou, Guangdong, China

Tongji Hospital Tongji Medical,Science & Technology ( Site 0407); 🇨🇳 Wuhan, Hubei, China

Hubei Cancer Hospital-Urinary surgery ( Site 0406); 🇨🇳 Wuhan, Hubei, China

Hunan Cancer Hospital ( Site 0405); 🇨🇳 Changsha, Hunan, China

First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0436); 🇨🇳 Huaian, Jiangsu, China

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 0377); 🇨🇳 NanJing, Jiangsu, China

Affiliated hospital of Jiangnan university ( Site 0434); 🇨🇳 Wuxi, Jiangsu, China

Jiangxi Cancer Hospital ( Site 0386); 🇨🇳 Nanchang, Jiangxi, China

The Second Affiliated Hospital of Xi'an Jiaotong University ( Site 0394); 🇨🇳 XI An, Shaanxi, China

The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 0393); 🇨🇳 Xi'an, Shaanxi, China

Yantai Yuhuangding Hospital ( Site 0397); 🇨🇳 Yantai, Shandong, China

Fudan University Shanghai Cancer Center-Urology department ( Site 0376); 🇨🇳 Shanghai, Shanghai, China

Huadong Hospital Affiliated to Fudan University-Urology ( Site 0388); 🇨🇳 Shanghai, Shanghai, China

West China Hospital, Sichuan University-Urology Surgery ( Site 0417); 🇨🇳 Cheng Du, Sichuan, China

The Third People's Hospital of Chengdu (CDTPH) ( Site 0428); 🇨🇳 Chengdu, Sichuan, China

Nanchong Central Hospital-urology ( Site 0422); 🇨🇳 Nanchong, Sichuan, China

Suining Central Hospital ( Site 0437); 🇨🇳 Suining, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital ( Site 0392); 🇨🇳 Tianjin, Tianjin, China

The Second Hospital of Tianjin Medical University ( Site 0391); 🇨🇳 Tianjin, Tianjin, China

Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 0419); 🇨🇳 Urumqi, Xinjiang, China

The Second Affiliated Hospital Of Kunming Medical University ( Site 0429); 🇨🇳 Kunming, Yunnan, China

Yunnan Province Cancer Hospital ( Site 0418); 🇨🇳 Kunming, Yunnan, China

Zhejiang Provincial People's Hospital-Urology ( Site 0378); 🇨🇳 Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital ( Site 0435); 🇨🇳 Hangzhou, Zhejiang, China

The First Hospital of Jiaxing-urology ( Site 0380); 🇨🇳 Jiaxing, Zhejiang, China

The First Affiliated Hospital of Ningbo University ( Site 0383); 🇨🇳 Ningbo, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 0379); 🇨🇳 Wenzhou, Zhejiang, China

Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0502); 🇨🇴 Valledupar, Cesar, Colombia

IMAT S.A.S ( Site 0504); 🇨🇴 Monteria, Cordoba, Colombia

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0501); 🇨🇴 Bogota, Distrito Capital De Bogota, Colombia

Fundación Cardiovascular de Colombia ( Site 0503); 🇨🇴 Piedecuesta, Santander, Colombia

Fundación Valle del Lili ( Site 0505); 🇨🇴 Cali, Valle Del Cauca, Colombia

Clínica Imbanaco S.A.S ( Site 0509); 🇨🇴 Cali, Valle Del Cauca, Colombia

Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0553); 🇨🇿 Brno, Brno-mesto, Czechia

Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0554); 🇨🇿 Ostrava, Moravskoslezsky Kraj, Czechia

Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0555); 🇨🇿 Olomouc, Olomoucky Kraj, Czechia

Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0551); 🇨🇿 Praha, Praha 5, Czechia

Rigshospitalet ( Site 0576); 🇩🇰 Copenhagen, Hovedstaden, Denmark

Odense Universitetshospital-Department of oncology ( Site 0579); 🇩🇰 Odense, Syddanmark, Denmark

Vejle Sygehus ( Site 0578); 🇩🇰 Vejle, Syddanmark, Denmark

Tampereen yliopistollinen sairaala ( Site 0604); 🇫🇮 Tampere, Pirkanmaa, Finland

Kuopion Yliopistollinen Sairaala ( Site 0603); 🇫🇮 Kuopio, Pohjois-Savo, Finland

Turku University Hospital-Department of Oncology ( Site 0601); 🇫🇮 Turku, Varsinais-Suomi, Finland

Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0627); 🇫🇷 Strasbourg, Alsace, France

Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire ( Site 0630); 🇫🇷 Nîmes, Gard, France

Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0632); 🇫🇷 Rennes, Ille-et-Vilaine, France

Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0629); 🇫🇷 Clermont-Ferrand, Puy-de-Dome, France

Centre Hospitalier de la Côte Basque ( Site 0633); 🇫🇷 Bayonne, Pyrenees-Atlantiques, France

Gustave Roussy ( Site 0626); 🇫🇷 Villejuif, Val-de-Marne, France

Hôpital Européen Georges Pompidou ( Site 0628); 🇫🇷 Paris, France

klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0696); 🇩🇪 Munich, Bayern, Germany

HELIOS Kliniken Schwerin ( Site 0694); 🇩🇪 Schwerin, Mecklenburg-Vorpommern, Germany

Universitätsklinikum Bonn-Klinik und Poliklinik für Urologie und Kinderurologie ( Site 0680); 🇩🇪 Bonn, Nordrhein-Westfalen, Germany

Universitätsklinikum Münster - Albert Schweitzer Campus-Klinik für Urologie ( Site 0678); 🇩🇪 Münster, Nordrhein-Westfalen, Germany

Ospedale San Raffaele-Oncologia Medica ( Site 0876); 🇮🇹 Milano, Italy

Universitätsklinikum Schleswig-Holstein-Klinik für Urologie ( Site 0691); 🇩🇪 Lubeck, Schleswig-Holstein, Germany

Universitätsklinikum Jena-Klinik und Poliklinik für Urologie ( Site 0682); 🇩🇪 Jena, Thuringen, Germany

Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0679); 🇩🇪 Berlin, Germany

Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0705); 🇩🇪 Hamburg, Germany

Queen Mary Hospital ( Site 0727); 🇭🇰 Hksar, Hong Kong

Prince of Wales Hospital ( Site 0730); 🇭🇰 Shatin, Hong Kong

Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 0752); 🇭🇺 Kecskemét, Bacs-Kiskun, Hungary

Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0761); 🇭🇺 Salgótarján, Nograd, Hungary

Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0756); 🇭🇺 Budapest, Pest, Hungary

Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0758); 🇭🇺 Debrecen, Hungary

St. Vincent's University Hospital ( Site 0802); 🇮🇪 Dublin, Ireland

Tallaght University Hospital ( Site 0801); 🇮🇪 Dublin, Ireland

Emek Medical Center ( Site 0830); 🇮🇱 Afula, Israel

Rambam Health Care Campus-Oncology Division ( Site 0826); 🇮🇱 Haifa, Israel

Hadassah Medical Center ( Site 0833); 🇮🇱 Jerusalem, Israel

Meir Medical Center. ( Site 0832); 🇮🇱 Kfar Saba, Israel

Rabin Medical Center ( Site 0828); 🇮🇱 Petah Tikva, Israel

Sheba Medical Center ( Site 0827); 🇮🇱 Ramat Gan, Israel

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 0879); 🇮🇹 Meldola, Emilia-Romagna, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0877); 🇮🇹 Milan, Lombardia, Italy

Toho University Sakura Medical Center ( Site 0906); 🇯🇵 Sakura, Chiba, Japan

Ehime University Hospital ( Site 0918); 🇯🇵 Toon, Ehime, Japan

Hospital of the University of Occupational and Environmental Health, Japan ( Site 0921); 🇯🇵 Kitakyushu, Fukuoka, Japan

Kurume University Hospital ( Site 0920); 🇯🇵 Kurume, Fukuoka, Japan

Asahikawa Medical University Hospital ( Site 0901); 🇯🇵 Asahikawa, Hokkaido, Japan

Sapporo Medical University Hospital ( Site 0902); 🇯🇵 Sapporo, Hokkaido, Japan

Hokkaido University Hospital ( Site 0931); 🇯🇵 Sapporo, Hokkaido, Japan

Kobe University Hospital ( Site 0914); 🇯🇵 Kobe, Hyogo, Japan

Kanazawa Medical University Hospital ( Site 0909); 🇯🇵 Uchinada, Ishikawa, Japan

Kagawa University Hospital ( Site 0917); 🇯🇵 Kita, Kagawa, Japan

Yokohama City University Medical Center ( Site 0908); 🇯🇵 Yokohama, Kanagawa, Japan

National Hospital Organization Nagasaki Medical Center ( Site 0923); 🇯🇵 Ōmura, Nagasaki, Japan

Nara Medical University Hospital ( Site 0915); 🇯🇵 Kashihara, Nara, Japan

Nanbu Tokushukai Hospital ( Site 0930); 🇯🇵 Shimajiri, Okinawa, Japan

Kansai Medical University Hospital ( Site 0912); 🇯🇵 Hirakata, Osaka, Japan

Bell Land General Hospital ( Site 0913); 🇯🇵 Sakai, Osaka, Japan

The University of Osaka Hospital ( Site 0911); 🇯🇵 Suita, Osaka, Japan

Saga-Ken Medical Centre Koseikan ( Site 0922); 🇯🇵 Saga-shi, Saga, Japan

The Jikei University Hospital ( Site 0907); 🇯🇵 Minato, Tokyo, Japan

Akita University Hospital ( Site 0904); 🇯🇵 Akita, Japan

Kyushu University Hospital ( Site 0919); 🇯🇵 Fukuoka, Japan

Fukushima Medical University Hospital ( Site 0933); 🇯🇵 Fukushima, Japan

Gifu University Hospital ( Site 0910); 🇯🇵 Gifu, Japan

Hiroshima University Hospital ( Site 0916); 🇯🇵 Hiroshima, Japan

Kagoshima University Hospital ( Site 0929); 🇯🇵 Kagoshima, Japan

National Hospital Organization Kumamoto Medical Center ( Site 0924); 🇯🇵 Kumamoto, Japan

Miyazaki Prefectural Miyazaki Hospital ( Site 0927); 🇯🇵 Miyazaki, Japan

University of Miyazaki Hospital ( Site 0926); 🇯🇵 Miyazaki, Japan

Nagano Municipal Hospital ( Site 0932); 🇯🇵 Nagano, Japan

National Hospital Organization Oita Medical Center ( Site 0925); 🇯🇵 Oita, Japan

Asan Medical Center-Oncology ( Site 1402); 🇰🇷 Songpagu, Seoul, Korea, Republic of

Seoul National University Hospital-Oncology ( Site 1401); 🇰🇷 Seoul, Korea, Republic of

Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1404); 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center ( Site 1405); 🇰🇷 Seoul, Korea, Republic of

Hospital Sultan Ismail ( Site 1081); 🇲🇾 Johor Bahru, Johor, Malaysia

University Malaya Medical Centre ( Site 1077); 🇲🇾 Lembah Pantai, Kuala Lumpur, Malaysia

Sarawak General Hospital-Radiotherapy Unit ( Site 1076); 🇲🇾 Kuching, Sarawak, Malaysia

National Cancer Institute ( Site 1079); 🇲🇾 Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia

Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1078); 🇲🇾 Kuala Lumpur, Malaysia

Quemex Medical and Research ( Site 1112); 🇲🇽 Mexico City, Distrito Federal, Mexico

Clínica Sánchez Ferrer ( Site 1261); 🇵🇪 Trujillo, La Libertad, Peru

CIO - Centro de Inmuno-Oncología de Occidente ( Site 1103); 🇲🇽 Guadalajara, Jalisco, Mexico

Filios Alta Medicina ( Site 1106); 🇲🇽 Monterrey, Nuevo Leon, Mexico

Medical Care and Research SA de CV ( Site 1108); 🇲🇽 Merida, Yucatan, Mexico

Centro de Investigacion Clinica de Oaxaca ( Site 1109); 🇲🇽 Oaxaca, Mexico

Medische Centrum Leeuwarden ( Site 1172); 🇳🇱 Leeuwarden, Fryslan, Netherlands

Radboudumc-Medical Oncology ( Site 1152); 🇳🇱 Nijmegen, Gelderland, Netherlands

Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1163); 🇳🇱 Sittard-Geleen, Limburg, Netherlands

VieCuri Medisch Centrum ( Site 1173); 🇳🇱 Venlo, Limburg, Netherlands

ETZ Elisabeth-Internal Medicine ( Site 1160); 🇳🇱 Tilburg, Noord-Brabant, Netherlands

Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1153); 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Amsterdam UMC, locatie VUmc ( Site 1156); 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Spaarne Gasthuis - Hoofddorp-Oncology ( Site 1170); 🇳🇱 Hoofddorp, Noord-Holland, Netherlands

Meander Medisch Centrum ( Site 1157); 🇳🇱 Amersfoort, Utrecht, Netherlands

Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1164); 🇳🇱 Den Haag, Zuid-Holland, Netherlands

Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1151); 🇳🇱 Schiedam, Zuid-Holland, Netherlands

Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1201); 🇳🇿 Tauranga, Bay Of Plenty, New Zealand

Dunedin Hospital-Southern Blood and Cancers Service ( Site 1203); 🇳🇿 Dunedin, Otago, New Zealand

Akershus Universitetssykehus-Onkologisk avdeling ( Site 1227); 🇳🇴 Lørenskog, Akershus, Norway

Sykehuset Østfold Kalnes ( Site 1228); 🇳🇴 Sarpsborg, Ostfold, Norway

St. Olavs Hospital-Kreftklinikken ( Site 1231); 🇳🇴 Trondheim, Sor-Trondelag, Norway

Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 1258); 🇵🇪 Concepcion, Junin, Peru

IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1254); 🇵🇪 Lima, Peru

Oncosalud-Clinical Research ( Site 1260); 🇵🇪 Lima, Peru

INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1256); 🇵🇪 Lima, Peru

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1302); 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland

Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 1316); 🇵🇱 Grudziadz, Kujawsko-pomorskie, Poland

Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 1304); 🇵🇱 Torun, Kujawsko-pomorskie, Poland

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1310); 🇵🇱 Siedlce, Mazowieckie, Poland

Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 1318); 🇵🇱 Kielce, Swietokrzyskie, Poland

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1303); 🇵🇱 Koszalin, Zachodniopomorskie, Poland

Zachodniopomorskie Centrum Onkologii ( Site 1311); 🇵🇱 Szczecin, Zachodniopomorskie, Poland

Puerto Rico Medical Research Center LLC ( Site 1354); 🇵🇷 Hato Rey, Puerto Rico

Ad-Vance Medical Research-Research ( Site 1353); 🇵🇷 Ponce, Puerto Rico

Pan American Center for Oncology Trials - Ciudadela ( Site 1351); 🇵🇷 San Juan, Puerto Rico

National University Hospital ( Site 1376); 🇸🇬 Singapore, Central Singapore, Singapore

National Cancer Centre Singapore ( Site 1377); 🇸🇬 Singapore, Central Singapore, Singapore

Tan Tock Seng Hospital-Medical Oncology ( Site 1378); 🇸🇬 Singapore, Central Singapore, Singapore

Hospital Jerez de la Frontera ( Site 1427); 🇪🇸 Jerez de la Frontera, Cadiz, Spain

Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1431); 🇪🇸 Madrid, Madrid, Comunidad De, Spain

Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1433); 🇪🇸 Madrid, Madrid, Comunidad De, Spain

Complexo Hospitalario Universitario de Ourense ( Site 1426); 🇪🇸 Ourense, Orense, Spain

Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1430); 🇪🇸 Valencia, Valenciana, Comunitat, Spain

Hospital Lucus Augusti-Oncology ( Site 1432); 🇪🇸 Lugo, Spain

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1428); 🇪🇸 Sevilla, Spain

Karolinska Universitetssjukhuset Solna ( Site 1478); 🇸🇪 Stockholm, Stockholms Lan, Sweden

Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1477); 🇸🇪 Uppsala, Uppsala Lan, Sweden

Sahlgrenska Universitetssjukhuset ( Site 1479); 🇸🇪 Gothenburg, Vastra Gotalands Lan, Sweden

China Medical University Hospital-Department of Urology ( Site 1503); 🇨🇳 Taichung, Taiwan

National Cheng Kung University Hospital-Urology ( Site 1502); 🇨🇳 Tainan, Taiwan

National Taiwan University Hospital-Urology ( Site 1506); 🇨🇳 Taipei, Taiwan

Taipei Veterans General Hospital ( Site 1505); 🇨🇳 Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1504); 🇨🇳 Taoyuan, Taiwan

Faculty of Medicine - Khon Kaen University ( Site 1526); 🇹🇭 Muang, Khon Kaen, Thailand

Chulalongkorn University ( Site 1530); 🇹🇭 Bangkok, Krung Thep Maha Nakhon, Thailand

Faculty of Medicine Siriraj Hospital ( Site 1531); 🇹🇭 Bangkok, Krung Thep Maha Nakhon, Thailand

Songklanagarind hospital ( Site 1527); 🇹🇭 Hatyai, Songkhla, Thailand

Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1554); 🇹🇷 Adana, Turkey

Gulhane Egitim Arastirma Hastanesi ( Site 1558); 🇹🇷 Ankara, Turkey

Hacettepe Universite Hastaneleri-oncology hospital ( Site 1551); 🇹🇷 Ankara, Turkey

Memorial Ankara Hastanesi-Medical Oncology ( Site 1557); 🇹🇷 Ankara, Turkey

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1552); 🇹🇷 Ankara, Turkey

Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1555); 🇹🇷 Istanbul, Turkey

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1553); 🇹🇷 Istanbul, Turkey

Addenbrooke's Hospital ( Site 1605); 🇬🇧 Cambridge, Cambridgeshire, United Kingdom

The Royal Cornwall Hospital ( Site 1610); 🇬🇧 Truro, England, United Kingdom

The Beatson West of Scotland Cancer Centre ( Site 1603); 🇬🇧 Glasgow, Glasgow City, United Kingdom

Charing Cross Hospital-Oncology Research ( Site 1606); 🇬🇧 London, Hammersmith And Fulham, United Kingdom

University College London Hospital ( Site 1612); 🇬🇧 London, London, City Of, United Kingdom

The Christie NHS Foundation Trust ( Site 1608); 🇬🇧 Manchester, United Kingdom