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NCT06855277 · ClinicalTrials.gov registry record · Phase 3
Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC
A Phase 3 study of Prostate Cancer, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 940
- Enrollment target
- 20
- Study locations
NCT06855277: Recruiting Phase 3 study of Prostate Cancer, sponsored by Novartis Pharmaceuticals.
NCT06855277 is a Phase 3 study of Prostate Cancer that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 940 participants, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06855277, a Phase 3 study of Prostate Cancer, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 940 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Time to radiographic disease progression or death due to any cause.
Conditions Studied
Interventions
- DRUG Standard of Care
- DRUG AAA817
- DRUG ARPI
Study Locations (20)
New York
- Bassett Medical Center - Cooperstown
- Weill Cornell Medicine NY-Presb - New York
- University of Rochester Medical Ctr - Rochester
- Associated Med Professionals of NY - Syracuse
Florida
- Miami Cancer Institute at Bapt - Miami
- AdventHealth - Orlando
São Paulo
- Novartis Investigative Site - São Paulo
- Novartis Investigative Site - São Paulo
California
- Sansum Clinic - Santa Barbara
Colorado
- Rocky Mountain Cancer Centers - Denver
Iowa
- Univ Of Iowa Hospitals And Clinics - Iowa City
Kansas
- University of Kansas Hospital - Kansas City
Missouri
- Wash U School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 940 participants |
| Start Date | 2025-07-01 |
| Est. Completion | 2032-11-04 |
| Phase | Phase 3 |
What NCT06855277 shows while recruiting
NCT06855277 is an interventional study that assigns participants to a tested intervention. The registered 940 participants enrollment target is mid-sized for trials with a published cap, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (55% higher).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Standard of Care is the first listed.
NCT06855277 names 20 study sites across 15 states, led by New York, Florida, São Paulo.
Frequently Asked Questions
What is clinical trial NCT06855277 about?
NCT06855277 is a clinical study titled "Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC". 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 stan...
What is the current status of trial NCT06855277?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 940 participants. The study started on 2025-07-01. Estimated completion is 2032-11-04.
What conditions does trial NCT06855277 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT06855277?
The interventions under investigation include: Standard of Care (DRUG), AAA817 (DRUG), ARPI (DRUG).
Who is sponsoring clinical trial NCT06855277?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06855277 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Iowa, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06855277's enrollment target sits among peer trials
940 71st of 735 higher than 665 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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