A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC

ClinicalTrials.gov ID: NCT05849298

Public ClinicalTrials.gov record NCT05849298. 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.

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ClinicalTrials.gov public records Last synced Sep 7, 2026, 1:46 AM EDT

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Official title

An International Prospective Open-label, Multi-center, Randomized, Non-comparative Phase II Study of Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) Alone and Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) in Combination With Androgen Receptor Pathway Inhibitors in Patients With PSMA PET Scan Positive Castration-Resistant Prostate Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the efficacy and safety of AAA617 alone (Lutetium \[177Lu\] vipivotide tetraxetan) and in combination with an Androgen Receptor Pathway Inhibitors (ARPI) in participants with PSMA-positive, castration-resistant prostate cancer and no evidence of metastasis in conventional imaging (CI) (i.e., CT/MRI and bone scans).

Study identification

NCT ID: NCT05849298
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Novartis Pharmaceuticals; Industry
Enrollment: 49 participants

Conditions and interventions

Conditions

Prostatic Neoplasm

Interventions

Drug · Other

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: Jan 2, 2024
Primary completion: Dec 22, 2026
Completion: Dec 22, 2026
Last update posted: Jul 16, 2026

2024 – 2026

United States locations

U.S. sites: 11
U.S. states: 9
U.S. cities: 11

Facility	City	State	ZIP	Site status
Rocky Mountain Cancer Centers	Denver	Colorado	80218	—
University Cancer and Blood Center LLC	Athens	Georgia	30607	—
Urology Of Indiana	Indianapolis	Indiana	46254	—
Unity Point Clinic	Des Moines	Iowa	50323	—
Urology Cancer Center PC	Omaha	Nebraska	68130	—
Associated Med Professionals of NY	Syracuse	New York	13210	—
Oregon Urology Institute	Springfield	Oregon	97477	—
Wellspan York Hospital	York	Pennsylvania	17403	—
Univ of Texas Southwest Med Center	Dallas	Texas	75390-9034	—
Rio Grande Urology	El Paso	Texas	79912	—
Houston Methodist Hospital	Houston	Texas	77030	—

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 21 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05849298, 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 Jul 16, 2026 · Synced Sep 7, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05849298 live on ClinicalTrials.gov.

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