ClinicalTrials.gov record
Active, not recruiting Phase 2 Interventional

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.

ClinicalTrials.gov public records Last synced May 7, 2026, 9:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

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

Interventions

  • AAA517 Drug
  • AAA617 Drug
  • ADT Drug
  • ARPI Drug
  • Best supportive care Other
  • Piflufolastat F 18 Drug

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
Apr 12, 2026

2024 – 2026

United States locations

U.S. sites
18
U.S. states
12
U.S. cities
16
Facility City State ZIP Site status
Urology Associates of Mobile Mobile Alabama 36608
Rocky Mountain Cancer Centers Denver Colorado 80218
University Of Florida Jacksonville Florida 32218
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
Coastal Cancer Center Conway South Carolina 29526
Carolina Urologic Research Center Myrtle Beach South Carolina 29572
Carolina Regional Cancer Center Myrtle Beach South Carolina 29577
Urology Clinic of North Texas Dallas Texas 75231
Univ of Texas Southwest Med Center Dallas Texas 75390-9034
Rio Grande Urology El Paso Texas 79912
Houston Methodist Hospital Houston Texas 77030
UT Health San Antonio Mays Cancer Center San Antonio Texas 78229

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 23 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 Apr 12, 2026 · Synced May 7, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

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

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