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

PHASE2RecruitingINTERVENTIONAL
Enrollment

420

Participants

Timeline

Start Date

September 11, 2025

Primary Completion Date

April 9, 2029

Study Completion Date

April 9, 2029

Conditions
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Interventions
DRUG

AAA617

"Dose formulation: open-label vial~Dose level: 7.4 GBq (200 mCi) ± 10% Once, every 6 weeks for 6 cycles, intravenous administration"

DRUG

ARPI: Abiraterone

"Dose formulation: tablet/capsule~Dose level: 160 mg (four 40 mg or two 80 mg soft capsules) as a single daily dose, oral administration"

DRUG

ARPI: Enzalutamide

"Dose formulation: tablet~Dose level: 1000 mg daily (two 500 mg tablets or four 250 mg tablets as a single daily dose together with 5 mg oral prednisone 2 times a day, oral administration"

Trial Locations (5)

68130

RECRUITING

Urology Cancer Center PC, Omaha

72703

RECRUITING

Highlands Oncology Group, Fayetteville

78229

RECRUITING

Urology San Antonio, San Antonio

85122

RECRUITING

Cancer And Blood Spclsts of AZ, Casa Grande

92663

RECRUITING

Hoag Memorial Hospital Presbyterian, Newport Beach

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY