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NCT06894511 · ClinicalTrials.gov registry record · Phase 2
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC
A Phase 2 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC), sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
- 13
- Study locations
NCT06894511: Active Phase 2 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC), sponsored by Novartis Pharmaceuticals.
NCT06894511 is a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC) that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 7 participants, below the 413-participant average among 15 other Metastatic Castration-Resistant Prostate Cancer (mCRPC) trials with a reported enrollment target (98% lower). The trial reports 13 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06894511, a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC), is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
- 13
- Study locations
Study Summary
The purpose of this study is to assess whether the combination of AAA617 (administered for 6 cycles at a dose of 7.4 GBq (200 mCi) +/- 10%) and ARPI improves radiographic progression-free survival (rPFS) or time to death compared to AAA617 alone in PSMA-positive mCRPC patients who were previously treated and progressed on ARPI in the biochemical recurrence (BCR)-non metastatic hormone sensitive prostate cancer (mHSPC), mHSPC, or non-metastatic Castration Resistant Prostate Cancer (nmCRPC) setting and have not previously received a taxane-containing regimen in the castrate resistant prostate cancer (CRPC) setting.
Primary Outcome
Number of participants with adverse events (AEs) and serious adverse events (SAEs).
Conditions Studied
Interventions
- DRUG AAA617
- DRUG ARPI: Abiraterone
- DRUG ARPI: Enzalutamide
Study Locations (13)
Texas
- Texas Oncology P A - Bedford
- Urology Austin - Lakeway
- Urology San Antonio - San Antonio
Arizona
- Cancer And Blood Spclsts of AZ - Casa Grande
- Arizona Center for Cancer Care - Gilbert
Arkansas
- Highlands Oncology Group - Fayetteville
California
- Hoag Memorial Hospital Presbyterian - Newport Beach
Colorado
- Univ Of Color Anschutz Med Center - Aurora
Florida
- Cancer Specialists of North Florida - Jacksonville
Louisiana
- East Jefferson Hospital - Metairie
Nebraska
- Urology Cancer Center PC - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2025-09-11 |
| Est. Completion | 2029-04-09 |
| Phase | Phase 2 |
What the registry record for NCT06894511 still lists
NCT06894511 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 413-participant average among 15 other Metastatic Castration-Resistant Prostate Cancer (mCRPC) trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer (mCRPC) appearing as the primary indexed condition, and to 3 interventions - of which AAA617 is the first listed.
NCT06894511 lists 13 locations in 10 states (Texas, Arizona, Arkansas).
Frequently Asked Questions
What is clinical trial NCT06894511 about?
NCT06894511 is a clinical study titled "An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC". The purpose of this study is to assess whether the combination of AAA617 (administered for 6 cycles at a dose of 7.4 GBq (200 mCi) +/- 10%) and ARPI improves radiographic progression-free survival (rPFS) or time to death compared to AAA617 alone in PSMA-positive mCRPC patients who were previously tr...
What is the current status of trial NCT06894511?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2025-09-11. Estimated completion is 2029-04-09.
What conditions does trial NCT06894511 study?
This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC).
What interventions are being tested in trial NCT06894511?
The interventions under investigation include: AAA617 (DRUG), ARPI: Abiraterone (DRUG), ARPI: Enzalutamide (DRUG).
Who is sponsoring clinical trial NCT06894511?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06894511 being conducted?
This trial has 13 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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