NCT06329830

177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer

Safety and Anti-tumor Activity of Lutetium-177 (177Lu)-PSMA-617 Along With Niraparib and Abiraterone Acetate Plus Prednisone in Metastatic Castration Resistant Prostate Cancer - LUNAAR Study

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Baptist Health South Florida · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to test the safety and possible side effects of Lutetium-177 (177Lu)-Prostate-Specific Membrane Antigen (PSMA)-617 along with niraparib and abiraterone acetate plus prednisone when it is given to people diagnosed with metastatic castration-resistant prostate cancer (prostate cancer that has spread to other parts of the body and does not improve with hormonal therapies) at different dose levels. Once an optimal dose is selected, the researchers want to find out what how well these treatments work to improve survival and control the growth of the tumor.

Conditions

• Metastatic Prostate Cancer
• Castration-resistant Prostate Cancer
• Metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	177Lu-PSMA-617	7.4 GBq (200 mCi) via IV infusion once every 6 weeks for 6 cycles
DRUG	Niraparib abiraterone acetate	Dual action drug tablet that is taken orally by the participant once per day in one of the following dose combinations depending on the cohort assignment and number of dose-limiting toxicities: 200 mg/1000 mg, 150 mg/1000 mg, 100 mg/1000 mg, 50 mg/500 mg
DRUG	Prednisone	5 mg orally twice per day

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-10-01
• Completion: 2028-10-01
• First posted: 2024-03-26
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study