Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC
Public ClinicalTrials.gov record NCT06855277. 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
A Phase III, Open-label, Multi-center, Randomized Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine whether \[225Ac\]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or \[177Lu\]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.
Study identification
- NCT ID
- NCT06855277
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 940 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 30, 2025
- Primary completion
- Sep 28, 2028
- Completion
- Nov 3, 2032
- Last update posted
- Aug 26, 2026
2025 – 2032
United States locations
- U.S. sites
- 37
- U.S. states
- 22
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Urology Centers Of Alabama Pc | Homewood | Alabama | 35209 | Recruiting |
| Stanford University Medical Center | Palo Alto | California | 94304 | Recruiting |
| Sansum Clinic | Santa Barbara | California | 93105 | Recruiting |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | Recruiting |
| Florida Cancer Specialists | Fort Myers | Florida | 33901 | Recruiting |
| Baptist Health South | Miami | Florida | 33173 | Recruiting |
| AdventHealth | Orlando | Florida | 32804 | Recruiting |
| University Cancer and Blood Center LLC | Athens | Georgia | 30607 | Recruiting |
| Northwestern University | Chicago | Illinois | 60611 | Recruiting |
| University of Illinois Cancer Center at Chicago | Chicago | Illinois | 60612 | Recruiting |
| Univ Of Iowa Hospitals And Clinics | Iowa City | Iowa | 52242 | Recruiting |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | Recruiting |
| East Jefferson Hospital | Metairie | Louisiana | 70006 | Recruiting |
| Beth Israel Deaconess Med Center | Boston | Massachusetts | 02215 | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | Recruiting |
| Wash U School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68154 | Recruiting |
| Astera Cancer Center | East Brunswick | New Jersey | 08816 | Recruiting |
| New Jersey Urology LLC | Voorhees Township | New Jersey | 08043 | Recruiting |
| New Mexico Oncology Hematology | Albuquerque | New Mexico | 87109 | Recruiting |
| Bassett Medical Center | Cooperstown | New York | 13326 | Recruiting |
| Weill Cornell Medicine NY-Presb | New York | New York | 10021 | Recruiting |
| University of Rochester Medical Ctr | Rochester | New York | 14642 | Recruiting |
| Associated Med Professionals of NY | Syracuse | New York | 13210 | Recruiting |
| Montefiore Medical Center | The Bronx | New York | 10461 | Recruiting |
| Urology Group - Solaris Network | Cincinnati | Ohio | 45212 | Recruiting |
| Central Ohio Urology Group | Gahanna | Ohio | 43230 | Recruiting |
| MUSC Hollings Cancer Center | Charleston | South Carolina | 29425 | Recruiting |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | Recruiting |
| Tennessee Oncology PLLC | Chattanooga | Tennessee | 37404 | Recruiting |
| Urology Austin | Lakeway | Texas | 78738 | Recruiting |
| Urology San Antonio | San Antonio | Texas | 78229 | Recruiting |
| Woodlands Cancer Institute American Oncology Partners | The Woodlands | Texas | 77384 | Recruiting |
| Swedish Medical Center | Seattle | Washington | 98122-4379 | Recruiting |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Recruiting |
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 58 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06855277, 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 Aug 26, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06855277 live on ClinicalTrials.gov.