An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With SoC, Versus SoC Alone, in Adult Male Patients With mHSPC

NCT ID: NCT04720157

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-09

Study Completion Date

2027-02-11

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with mHSPC. In this study, the SoC is defined as a combination of Androgen Receptor Directed Therapy + Androgen Deprivation Therapy. Approximately 1126 patients will be randomized in this study. As of 31-Jan-2024, 1144 participants have been enrolled in 20 countries.

Detailed Description

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In this international, open-label, prospective, phase III study, where approximately 1126 patients with treatment naïve or minimally treated PSMA-positive mHSPC will be randomized in a 1:1 ratio to receive Standard of Care (SoC) with or without the radioligand 177Lu-PSMA-617.

The primary objective of the study is to determine whether the combination of 177Lu-PSMA-617 + SoC improves rPFS over that obtained by administration of SoC alone in mHSPC patients.

The randomization will be stratified according to the following three factors: disease volume (high v low), age \>= 70 years (yes/no), and on Previous or planned treatment (prostatectomy or radiation) to primary (prostate) tumor (yes/no).

Study duration: approximately 50 months. screening period: after signing ICF, patients will be assessed for eligibility and will be scanned with 68Ga PSMA-11 to identify PSMA expression status. Following completion of all required screening procedures and verifying participant eligibility, the participant will be randomized via the interactive response technology (IRT) system.

Amended protocol v02 included an option for participants to be enrolled into a separate long-term safety follow-up study, and China extension cohort (40 to 60 participants). Amended protocol v03 excluded China extension cohort and added a second 68Ga-PSMA-11 PET/CT scan at rPD.

Prior treatment:

* Up to 45 days of LHRH agonist/antagonists is allowed prior to ICF signature. If patient did not start the ADT prior randomization, ADT should start as soon as possible and ideally no later than 2 weeks after randomization.
* Up to 45 days of ARDT is allowed prior ICF signature. If patient did not start the ARDT prior randomization, ARDT should start as soon as possible and ideally no later than 2 weeks after randomization. Patients will received ARDT as per label instructions.

Randomization period:

The participant will be randomized in a 1:1 ratio to receive Standard of Care (SoC) with or without the radioligand 177Lu-PSMA-617.

Treatment period:

Patients randomized to the investigational arm (i.e. SoC+177Lu-PSMA-617): Patients will receive SoC as per label instructions, after randomization, if not started earlier and in the time frame allowed by the protocol. Patients must begin 177Lu-PSMA-617 dosing within 14 days after randomization or as soon as possible after the product is received. 177Lu-PSMA-617 is administered at the dose of 7.4 GBq (+/- 10%), once every 6 weeks (+/- 1 week) for a planned 6 cycles.

Patients randomized to the control arm will begin receiving SoC as per label instructions after randomization, if not started earlier and in the time frame allowed by the protocol.

The primary endpoint of rPFS will be assessed by a centralized blinded image review committee (i.e., BIRC) using radiographic images provided by the treating physician.

Participants from both arms will also undergo PET/CT scan with 68GaPSMA-11 following Centrally confirmed rPD.

An end of treatment (EOT) visit will be performed when participants permanently discontinue study treatment.

Cross-over period:

After patients randomized to the SoC alone (i.e., control) arm experience radiographic progression (the rPFS event) as confirmed by BIRC, they will be allowed to cross-over to receive 177Lu-PSMA-617 +/- SoC per the discretion of the treating physician. If cross-over to 177Lu-PSMA-617 is selected, then 177Lu-PSMA-617 will be administered with the same dose/schedule as participants who were initially randomized to receive 177Lu-PSMA-617 as described above. Study cross-over participants for whom 177Lu-PSMA-617 is discontinued must have a second End of Treatment (EOT2) visit performed =\< 7 days and enter the Post-treatment Follow-up .

Post-Treatment Follow-Up (Safety, Efficacy):

After treatment discontinuation, all participants will be followed for safety with a 30-day safety follow-up visit (FUP) as well as longer term safety follow-up assessments for a period of approximately 12 months.

Participants who discontinue study treatment without having progressive disease confirmed by BIRC, will continue to be assessed for efficacy (efficacy follow-up) during the post-treatment follow-up period until the occurrence of their BIRC-confirmed radiographic disease progression (rPFS) event , or if the total number of protocol-defined rPFS events has occurred triggering the primary analysis, whichever occurs first.

Survival Follow-Up:

After study treatment discontinuation, or post-treatment follow-up period discontinuation, the participant's status will be collected every 90 days (via phone calls) as part of the survival follow-up. Every effort should be made to comply with the survival follow-up schedule and ensure collection of participant survival. The survival follow-up and the study will end when the number of OS events required for final OS analysis will be reached.

Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patient randomized to SOC arm have an option to crossover to 177Lu-PSMA-617 treatment after rPFS
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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177Lu-PSMA-617

Participant will receive 7.4 GBq (+/- 10%) 177Lu-PSMA-617, once every 6 weeks (+/- 1 week) for a planned 6 cycles, in addition to the Standard of Care (SOC); ARDT +ADT is considered as SOC and treatment will be administered per the physician's order

Group Type EXPERIMENTAL

177Lu-PSMA-617

Intervention Type DRUG

administered intravenously once every 6 weeks (1 cycle) for 6 cycles

68Ga-PSMA-11

Intervention Type DRUG

Intravenous dose of approx. 150 Megabecquerel (MBq) at screening and at time of centrally confirmed rPD

ARDT

Intervention Type DRUG

Administered orally on a continuous basis as per package insert and guideline

ADT

Intervention Type DRUG

ADT are administered as per physician order

Standard of Care

For participants randomized to Standard of Care arm, ARDT +ADT is considered as SOC and treatment will be administered per the physician's order

Group Type ACTIVE_COMPARATOR

68Ga-PSMA-11

Intervention Type DRUG

Intravenous dose of approx. 150 Megabecquerel (MBq) at screening and at time of centrally confirmed rPD

ARDT

Intervention Type DRUG

Administered orally on a continuous basis as per package insert and guideline

ADT

Intervention Type DRUG

ADT are administered as per physician order

Interventions

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177Lu-PSMA-617

administered intravenously once every 6 weeks (1 cycle) for 6 cycles

Intervention Type DRUG

68Ga-PSMA-11

Intravenous dose of approx. 150 Megabecquerel (MBq) at screening and at time of centrally confirmed rPD

Intervention Type DRUG

ARDT

Administered orally on a continuous basis as per package insert and guideline

Intervention Type DRUG

ADT

ADT are administered as per physician order

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Participants eligible for inclusion in this study must meet all of the following criteria:

1. Signed informed consent must be obtained prior to participation in the study
2. Patients must be adults ≥18 years of age
3. Patients must have an ECOG performance status of 0 to 2
4. Patients must have a life expectancy \>9 months as determined by the study investigator
5. Patients must have metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma (current or prior biopsy of the prostate and/or metastatic site)
6. Patients must have evidence of PSMA-positive disease as seen on a 68Ga-PSMA-11 PET/CT scan, and eligible as determined by the sponsor's central reader
7. Patients must have at least one documented metastatic bone and/or soft tissue/visceral lesion documented in the following manners within 28 days prior randomization:

1. Metastatic disease to the bone (in any distribution) visible on 99Tc-MDP bone scintigraphy on either pre-ADT scans or baseline scans AND/OR
2. Lymph node metastases of any size or distribution. If lymph nodes are the only site of metastasis, then at least one must be at least 1.5 cm in short axis AND outside of the pelvis AND/OR
3. Visceral metastases of any size or distribution. If a participant has a history of visceral metastases at any time prior to randomization, he should be coded as having visceral metastases at baseline (i.e., patients with visceral metastases prior to ADT that disappear at baseline will be counted as having visceral metastases and would therefore have high volume disease for stratification purposes).
8. Patients must have adequate organ function:

* Bone marrow reserve ANC ≥1.5 x 109/L Platelets ≥100 x 109/L Hemoglobin ≥9 g/dL
* Hepatic Total bilirubin ≤2 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤3 x ULN is permitted Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3.0 x ULN OR ≤5.0 x ULN for patients with liver metastases
* Renal eGFR ≥ 50 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) equation
9. Albumin ≥2.5 g/dL
10. Human immunodeficiency virus (HIV)-infected patients who are healthy and have a low risk of acquired immune deficiency syndrome (AIDS)-related outcomes can participate in this trial
11. Patients must be:

Treatment naïve OR minimally treated with:

* Up to 45 days of luteinizing hormone-releasing hormone (LHRH) agonist /antagonists or bilateral orchiectomy with or without first generation anti-androgen (e.g. bicalutamide, flutamide) for metastatic prostate cancer is allowed prior to ICF signature. If given, first generation anti-androgen must be discontinued prior to start of study therapy or after 45 days whatever happens first.
* If received, prior LHRH agonist/antagonist with or without first generation anti-androgen use in the adjuvant/neo-adjuvant setting must have been discontinued \> 12 months prior to ICF signature AND must not have exceeded 24 months of therapy AND must not have shown disease progression within 12 months of completing adjuvant/neo-adjuvant therapy.
* Up to 45 days of CYP17 inhibitor or ARDT exposure for metastatic prostate cancer is allowed prior to ICF signature. No CYP17 inhibitor or ARDT exposure for earlier stages of prostate cancer is allowed.

3. Concurrent cytotoxicity chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy or investigational therapy
4. Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed
5. Ongoing participation in any other clinical trial
6. Use of other investigational drugs within 30 days prior to day of randomization
7. Known hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes
8. Transfusion for the sole purpose of making a participant eligible for study inclusion
9. Participants with CNS metastases that are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity. Participants with epidural disease, canal disease and prior cord involvement are allowed if those areas have been treated, are stable, and not neurologically impaired. Participants with parenchymal CNS metastasis (or a history of CNS metastasis), that have received prior therapy and are neurologically stable, asymptomatic and not receiving steroids for CNS metastases, are allowed, baseline and subsequent radiological imaging must include evaluation of the brain (magnetic resonance imaging (MRI) preferred or CT with contrast).
10. Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free, treatment free for more than 3 years prior to randomization, or participants with adequately treated non-melanoma skin cancer, superficial bladder cancer are eligible.
11. Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation. Participants with an active documented COVID-19 infection (any grade of disease severity) at time of informed consent may be included only when completely recovered (in accordance with local guidance).
12. Active clinically significant cardiac disease defined as any of the following:

* NYHA class 3/4 congestive heart failure within 6 months prior to ICF signature unless treated with improvement and echocardiogram or MUGA demonstrates EF \> 45% with improvement in symptoms to class \< 3.
* History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants in the study such as: Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third degree AV block)
* History of familial long QT syndrome or known family history of Torsades de Pointes
* Cardiac or cardiac repolarization abnormality, including any of the following: History of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature
13. History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
14. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression
15. Any condition that precludes raised arms position
16. Unmanageable concurrent bladder outflow obstruction or urinary incontinence. Note: participants with bladder outflow obstruction or urinary incontinence, which is manageable and controlled with best available standard of care (incl. pads, drainage) are allowed.
17. Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 14 weeks after stopping study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF

Exclusion Criteria

Participants meeting any of the following criteria are not eligible for inclusion in this study.

1. Participants with rapidly progressing tumor that requires urgent exposure to taxane-based chemotherapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Alliance Foundation Trials, LLC.

OTHER

Sponsor Role collaborator

RTOG Foundation, Inc.

OTHER

Sponsor Role collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Mayo Clinic - Arizona Mayo Clinic Hospital

Scottsdale, Arizona, United States

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Mayo Clinic Arizona

Scottsdale, Arizona, United States

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University of California San Diego - Moores Cancer Center

La Jolla, California, United States

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VA Greater LA Healthcare System

Los Angeles, California, United States

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University of California LA

Los Angeles, California, United States

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St. Joseph Hospital

Orange, California, United States

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Univ Cali Irvine ALS Neuromuscular

Orange, California, United States

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VA Palo Alto Health Care System

Palo Alto, California, United States

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Stanford University Medical Center

Palo Alto, California, United States

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Sansum Clinic

Santa Barbara, California, United States

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Providence Saint Johns Health Ctr

Santa Monica, California, United States

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Univ Of Color Anschutz Med Center

Aurora, Colorado, United States

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Rocky Mountain Cancer Centers

Denver, Colorado, United States

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Hartford Hospital

Hartford, Connecticut, United States

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Georgetown University-Lombardi Cancer Center

Washington D.C., District of Columbia, United States

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VA Medical Center

Washington D.C., District of Columbia, United States

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Mayo Clinic Jacksonville

Jacksonville, Florida, United States

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Cancer Specialists of North Florida

Jacksonville, Florida, United States

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University Of Miami

Miami, Florida, United States

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Miami Cancer Institute at Bapt

Miami, Florida, United States

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Florida Cancer Affiliates

Panama City, Florida, United States

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University Cancer and Blood Center LLC

Athens, Georgia, United States

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The Queens Medical Centre

Honolulu, Hawaii, United States

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Northwestern University

Chicago, Illinois, United States

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Rush University Medical Center

Chicago, Illinois, United States

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University of Chicago

Chicago, Illinois, United States

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Hines VA Hospital

Hines, Illinois, United States

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Parkview Research Center

Fort Wayne, Indiana, United States

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Indiana University

Indianapolis, Indiana, United States

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Tulane Cancer Center

New Orleans, Louisiana, United States

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Ochsner Clinic Foundation

New Orleans, Louisiana, United States

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Sidney Kimmel CCC At JH

Baltimore, Maryland, United States

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

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Uni Of Michigan Health System

Ann Arbor, Michigan, United States

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Corewell Health William Beaum Hosp

Royal Oak, Michigan, United States

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University of Minnesota

Minneapolis, Minnesota, United States

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Mayo Clinic Rochester

Rochester, Minnesota, United States

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Mayo Clinic

Rochester, Minnesota, United States

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University of Mississippi Med Ctr

Jackson, Mississippi, United States

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St. Louis University

St Louis, Missouri, United States

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VA St Louis Health Care System

St Louis, Missouri, United States

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Wash U School of Medicine

St Louis, Missouri, United States

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Nebraska Cancer Specialists

Omaha, Nebraska, United States

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Urology Cancer Center PC

Omaha, Nebraska, United States

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University of New Mexico

Albuquerque, New Mexico, United States

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Weill Cornell Medical College

New York, New York, United States

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Memorial Sloan Kettering Cancer Ctr

New York, New York, United States

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Univ Of Rochester Cancer Ctr

Rochester, New York, United States

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Montefiore Medical Center

The Bronx, New York, United States

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Levine Cancer Institute

Charlotte, North Carolina, United States

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Duke Univ Medical Center

Durham, North Carolina, United States

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

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The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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Oregon Health Sciences University

Portland, Oregon, United States

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Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

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Thomas Jefferson Univ Hosp

Philadelphia, Pennsylvania, United States

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Univ of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

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Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

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Dallas VA Medical Center

Dallas, Texas, United States

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Texas Oncology

Dallas, Texas, United States

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Univ of Texas Southwest Med Center

Dallas, Texas, United States

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MD Anderson

Houston, Texas, United States

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UT Health Science Center

Houston, Texas, United States

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UT Health San Antonio Mays Cancer Center

San Antonio, Texas, United States

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University of Virginia Medical Center

Charlottesville, Virginia, United States

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Virginia Oncology Associates

Norfolk, Virginia, United States

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Onco Hemato Asso of SW Virginia

Roanoke, Virginia, United States

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Swedish Medical Center

Seattle, Washington, United States

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Medical College Of Wisconsin

Milwaukee, Wisconsin, United States

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Novartis Investigative Site

Innsbruck, Tyrol, Austria

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Linz, , Austria

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Vienna, , Austria

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Brussels, , Belgium

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Ghent, , Belgium

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Vancouver, British Columbia, Canada

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Hamilton, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Nanjing, Jiangsu, China

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Nanjing, Jiangsu, China

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Xian, Shanxi, China

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Chengdu, Sichuan, China

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Beijing, , China

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Guangzhou, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Tianjin, , China

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Olomouc, , Czechia

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Prague, , Czechia

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Copenhagen, , Denmark

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Bordeaux, , France

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Clermont-Ferrand, , France

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Lyon, , France

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Montpellier, , France

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Nantes, , France

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Paris, , France

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Paris, , France

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Strasbourg, , France

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Vandœuvre-lès-Nancy, , France

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Villejuif, , France

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Würzburg, Bavaria, Germany

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Cologne, North Rhine-Westphalia, Germany

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Essen, , Germany

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München, , Germany

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Münster, , Germany

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Rostock, , Germany

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Nagoya, Aichi-ken, Japan

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Sapporo, Hokkaido, Japan

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Kobe, Hyōgo, Japan

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Yokohama, Kanagawa-ku, Japan

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Suita, Osaka, Japan

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Kitaadachi-gun, Saitama, Japan

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Bunkyo Ku, Tokyo, Japan

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Chuo Ku, Tokyo, Japan

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Chiba, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukushima, , Japan

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Kumamoto, , Japan

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Kyoto, , Japan

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Okayama, , Japan

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Yamagata, , Japan

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Nijmegen, Gelderland, Netherlands

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Maastricht, Limburg, Netherlands

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Delft, South Holland, Netherlands

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Utrecht, , Netherlands

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Gliwice, Silesian Voivodeship, Poland

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Krakow, , Poland

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Warsaw, , Poland

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Singapore, , Singapore

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Singapore, , Singapore

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Seoul, Korea, South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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L'Hospitalet de Llobregat, Barcelona, Spain

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Sabadell, Barcelona, Spain

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Majadahonda, Madrid, Spain

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El Palmar, Murcia, Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Valencia, , Spain

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Gothenburg, , Sweden

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Lund, , Sweden

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Stockholm, , Sweden

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Bern, , Switzerland

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Lausanne, , Switzerland

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Sutton, Surrey, United Kingdom

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Belfast, , United Kingdom

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Cambridge, , United Kingdom

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Glasgow, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Novartis Investigative Site

Middlesbrough, , United Kingdom

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Countries

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United States Austria Belgium Canada China Czechia Denmark France Germany Japan Netherlands Poland Singapore South Korea Spain Sweden Switzerland Taiwan United Kingdom

Other Identifiers

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2020-003968-56

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-507970-42-00

Identifier Type: OTHER

Identifier Source: secondary_id

CAAA617C12301

Identifier Type: -

Identifier Source: org_study_id

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