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Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC
NCT06855277 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06855277
The ClinicalTrials.gov registry entry for NCT06855277 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 940 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06855277 reports 20 study locations spanning 15 distinct geographic areas — top geographies include New York, Florida, São Paulo. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06855277?
The interventions under investigation include: Standard of Care (DRUG), AAA817 (DRUG), ARPI (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06855277?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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