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ACTIVE NOT RECRUITING Phase 2

An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC

NCT06894511 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 7 participants
Start Date 2025-09-11
Est. Completion 2029-04-09
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06894511

The ClinicalTrials.gov registry entry for NCT06894511 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 7 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 Metastatic Castration Resistant Prostate Cancer (mCRPC) appearing as the primary indexed condition, and to 3 interventions — of which AAA617 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: NCT06894511 reports 13 study locations spanning 10 distinct geographic areas — top geographies include Texas, Arizona, Arkansas. 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 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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06894511?

The interventions under investigation include: AAA617 (DRUG), ARPI: Abiraterone (DRUG), ARPI: Enzalutamide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06894511?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial