Niraparib + Abiraterone Acetate + Prednisone for Metastatic Prostate Cancer

(MAGNITUDE Trial)

Recruiting at409 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for men with metastatic prostate cancer who have specific genetic changes (HRR gene alteration), haven't had certain cancers or treatments like PARP inhibitors, and are on hormone therapy to keep testosterone low. They should not have symptomatic brain tumors or blood disorders like MDS/AML.

Inclusion Criteria

My prostate cancer has spread, and my testosterone is very low due to treatment or surgery.

I can continue hormone therapy during the study if I haven't had surgery to remove my testicles.

My cancer has a positive HRR gene alteration.

Exclusion Criteria

I have had specific prostate cancer treatments before joining this study.

I have or had myelodysplastic syndrome or acute myeloid leukemia.

I have brain metastases that are causing symptoms.

Treatment Details

Interventions

• Abiraterone Acetate (Androgen Biosynthesis Inhibitor)
• Niraparib (PARP Inhibitor)
• Placebo (Chemotherapy)
• Prednisone (Corticosteroid)

Trial Overview The study tests the effectiveness of Niraparib combined with Abiraterone Acetate and Prednisone against just Abiraterone Acetate and Prednisone in treating metastatic prostate cancer. Participants will be randomly assigned to either receive the combination treatment or the standard treatment plus a placebo.

Participant Groups

Group I: Cohort 3 (Open-label): Participants with mCRPC Experimental Treatment 2 Interventions

Participants with mCRPC will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets plus prednisone 10 mg.

Group II: Cohort 2: Participants with mCRPC and No HRR Gene Alteration Experimental Treatment 4 Interventions

Participants with L1 mCRPC and no HRR Gene alteration will receive combination of niraparib 200 mg or matching placebo and AA 1000 mg plus prednisone 10 mg. In the OLE phase participants earlier receiving the combination of niraparib and AAP may continue to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg and those receiving placebo and AAP may cross over depending on the outcome of study to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg.

Group III: Cohort 1: Participants with mCRPC and HRR Gene Alteration Experimental Treatment 4 Interventions

Participants with L1 metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alteration will receive combination of niraparib 200 milligrams (mg) or matching placebo and abiraterone acetate (AA) 1000 mg plus prednisone 10 mg. In the open label extension (OLE) phase participants earlier receiving the combination of niraparib and AAP may continue to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg and those receiving placebo and AAP may cross over depending on the outcome of study to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg.

Abiraterone Acetate is already approved in Canada, Japan for the following indications:

Approved in Canada as Zytiga for:

• Metastatic castration-resistant prostate cancer
• Metastatic castration-sensitive prostate cancer

Approved in Japan as Zytiga for:

• Prostate cancer

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires