Niraparib + Abiraterone Acetate and Prednisone for Prostate Cancer

(AMPLITUDE Trial)

Recruiting at512 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 the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

Men with prostate cancer that has spread and is sensitive to hormone therapy can join if they have specific gene changes related to DNA repair. They must have started hormone treatment at least two weeks before joining, but not had extensive prior treatments like radiation or certain drugs.

Inclusion Criteria

I started hormone therapy for my cancer more than 14 days ago and am willing to continue it.

I have prostate cancer and have had limited prior treatments for it.

My cancer has spread, confirmed by scans.

Exclusion Criteria

I am not on long-term steroids higher than 5mg of prednisone or equivalent.

I have been treated with a PARP inhibitor before.

I have or had myelodysplastic syndrome or acute myeloid leukemia.

Treatment Details

Interventions

• Abiraterone acetate (AA) (Androgen Deprivation Therapy)
• Niraparib (PARP Inhibitor)
• Prednisone (Steroid)

Trial Overview The trial tests if adding Niraparib (a drug for DNA repair defects) to Abiraterone Acetate and Prednisone improves outcomes in men whose prostate cancer has spread. Participants are randomly assigned to either the combination treatment or just AA plus prednisone.

Participant Groups

Group I: Niraparib with Abiraterone Acetate plus Prednisone (AAP) Experimental Treatment 3 Interventions

Participants will receive the following in each 28-day treatment cycle: niraparib 200 milligrams (mg), abiraterone acetate (AA) 1000 mg plus prednisone 5 mg once daily.

Group II: AA plus Prednisone (AAP) Active Control 3 Interventions

Participants will receive the following in each 28-day treatment cycle: matching placebo for Niraparib along with AA 1000 mg plus prednisone 5 mg once daily.

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