MedTrace Logo

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

NCT06329830 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • Baptist Health South Florida

    lead OTHER

Principal Investigators

  • Rohan Garje, M.D. · Miami Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2026-10-31
Completion
2028-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06329830 on ClinicalTrials.gov