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Androgen Deprivation Therapy

Niraparib + Abiraterone Acetate and Prednisone for Prostate Cancer (AMPLITUDE Trial)

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Androgen deprivation therapy (either medical or surgical castration) must have been started >=14 days prior to randomization and participants be willing to continue androgen deprivation therapy (ADT) through the treatment phase

Must have appropriate deleterious homologous recombination repair (HRR) gene alteration

Must not have

Prior treatment with a poly (adenosine diphosphate-ribose) polymerase (inhibitor) (PARP) inhibitor

History or current diagnosis of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 78 months

Awards & highlights

Pivotal Trial

Summary

This trial will compare the effect of two different treatments on metastatic prostate cancer patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Niraparib may cause nausea, fatigue, blood cell count issues, heart palpitations, and shortness of breath. Abiraterone can lead to high blood pressure, fluid retention, liver function changes, and muscle discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My cancer has a specific genetic change affecting DNA repair.

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I have been diagnosed with prostate cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with a PARP inhibitor before.

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I have or had myelodysplastic syndrome or acute myeloid leukemia.

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I have had issues with my adrenal glands.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 78 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 78 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 78 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Radiographic Progression-free Survival (rPFS)

Secondary study objectives

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Overall Survival (OS)

Time to Subsequent Therapy

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Niraparib with Abiraterone Acetate plus Prednisone (AAP)Experimental Treatment3 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 Control3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2500

Niraparib

2018

Completed Phase 4

~2400