An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
Public ClinicalTrials.gov record NCT04720157. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care, Versus Standard of Care Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care (SOC), versus Standard of Care alone, in adult male patients with Metastatic hormone sensitive prostate cancer (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 were enrolled in 20 countries.
Study identification
- NCT ID
- NCT04720157
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,140 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 9, 2021 (Actual)
- Primary completion
- Jan 13, 2025 (Actual)
- Completion
- Feb 11, 2027 (Estimated)
- Last update posted
- Jun 8, 2026
2021 – 2027
United States locations
- U.S. sites
- 70
- U.S. states
- 29
- U.S. cities
- 53
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic - Arizona Mayo Clinic Hospital | Scottsdale | Arizona | 85259 | — |
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | — |
| University of California San Diego - Moores Cancer Center | La Jolla | California | 92093-0658 | — |
| VA Greater LA Healthcare System | Los Angeles | California | 90073 | — |
| University of California LA | Los Angeles | California | 90095 | — |
| St. Joseph Hospital | Orange | California | 92686 | — |
| Univ Cali Irvine ALS Neuromuscular | Orange | California | 92868 | — |
| VA Palo Alto Health Care System | Palo Alto | California | 94304-1207 | — |
| Stanford University Medical Center | Palo Alto | California | 94304 | — |
| Sansum Clinic | Santa Barbara | California | 93105 | — |
| Providence Saint Johns Health Ctr | Santa Monica | California | 90404 | — |
| Univ Of Color Anschutz Med Center | Aurora | Colorado | 80045 | — |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| Georgetown University-Lombardi Cancer Center | Washington D.C. | District of Columbia | 20007 | — |
| VA Medical Center | Washington D.C. | District of Columbia | 20422 | — |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | — |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32256 | — |
| University Of Miami | Miami | Florida | 33136 | — |
| Baptist Health South | Miami | Florida | 33173 | — |
| Florida Cancer Affiliates | Panama City | Florida | 32405 | — |
| University Cancer and Blood Center LLC | Athens | Georgia | 30607 | — |
| The Queens Medical Centre | Honolulu | Hawaii | 96813 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Hines VA Hospital | Hines | Illinois | 60141 | — |
| Parkview Research Center | Fort Wayne | Indiana | 46845 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Tulane Cancer Center | New Orleans | Louisiana | 70112 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Sidney Kimmel CCC At JH | Baltimore | Maryland | 21231 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Uni Of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Corewell Health William Beaum Hosp | Royal Oak | Michigan | 48073-6769 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| University of Mississippi Med Ctr | Jackson | Mississippi | 39216 | — |
| St Louis University | St Louis | Missouri | 63104 | — |
| VA St Louis Health Care System | St Louis | Missouri | 63106 | — |
| Wash U School of Medicine | St Louis | Missouri | 63110 | — |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | — |
| Urology Cancer Center PC | Omaha | Nebraska | 68130 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 0001 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Memorial Sloan Kettering Cancer Ctr | New York | New York | 10065 | — |
| Univ Of Rochester Cancer Ctr | Rochester | New York | 14642 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Levine Cancer Institute | Charlotte | North Carolina | 28203 | — |
| Duke Univ Medical Center | Durham | North Carolina | 27710 | — |
| Duke Raleigh Hospital | Raleigh | North Carolina | 27609 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43221 | — |
| Oregon Health Sciences University | Portland | Oregon | 97239 | — |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Thomas Jefferson Univ Hosp | Philadelphia | Pennsylvania | 19107 | — |
| Univ of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15232 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| Texas Oncology | Amarillo | Texas | 79124 | — |
| Dallas VA Medical Center | Dallas | Texas | 75216 | — |
| Univ of Texas Southwest Med Center | Dallas | Texas | 75390-9034 | — |
| MD Anderson | Houston | Texas | 77030 | — |
| UT Health Science Center | Houston | Texas | 77030 | — |
| UT Health San Antonio Mays Cancer Center | San Antonio | Texas | 78229 | — |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | — |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | — |
| Onco Hemato Asso of SW Virginia | Roanoke | Virginia | 24014 | — |
| Swedish Medical Center | Seattle | Washington | 98122-4379 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 97 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04720157, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 8, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04720157 live on ClinicalTrials.gov.