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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 78 months

Awards & highlights

AMPLITUDE 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.Check my eligibility

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.See study design

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.

AMPLITUDE Trial 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.

AMPLITUDE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Radiographic Progression-free Survival (rPFS)

Secondary outcome measures

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

Overall Survival (OS)

Time to Subsequent Therapy

+1 more

AMPLITUDE 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

~2370

Niraparib

2018

Completed Phase 4

~1540

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,383,612 Total Patients Enrolled

8 Trials studying Prostate Cancer

2,178 Patients Enrolled for Prostate Cancer

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,209 Total Patients Enrolled

7 Trials studying Prostate Cancer

2,688 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone acetate (AA) (Androgen Deprivation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04497844 — Phase 3

Prostate Cancer Research Study Groups: AA plus Prednisone (AAP), Niraparib with Abiraterone Acetate plus Prednisone (AAP)

Prostate Cancer Clinical Trial 2023: Abiraterone acetate (AA) Highlights & Side Effects. Trial Name: NCT04497844 — Phase 3

Abiraterone acetate (AA) (Androgen Deprivation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04497844 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are investigators still looking for participants in this research project?

"Yes, as the clinicaltrials.gov website reports, this study is still actively recruiting patients. The study was first posted on September 23rd 2020, with the latest update being October 25th 2022."

Answered by AI

What are some of the conditions that Abiraterone acetate (AA) has been shown to be effective for?

"Abiraterone acetate (AA) is a medication used to treat thyroiditis. However, it has also been shown to be helpful for patients with other diagnoses like ulcerative colitis, malignant neoplasms, and varicella-zoster virus acute retinal necrosis."

Answered by AI

If there are many sites conducting this research, where are they located?

"The participating medical institutions for this clinical trial are Texas Oncology-Denton South, University Health Network Princess Margaret Cancer Centre, Prisma Health, and 71 other locations."

Answered by AI

What other research has been conducted on Abiraterone acetate (AA)?

"At the moment, there are 461 ongoing studies involving abiraterone acetate (AA). 111 of those studies are in phase 3. The majority of trials for AA are taking place in Duarte, California, but there are 18739 total locations running studies for this treatment."

Answered by AI

Could you please explain the possible risks associated with Abiraterone acetate?

"Abiraterone acetate (AA) has received a safety rating of 3 from our team at Power. This is due to the fact that AA is a Phase 3 trial, and thus there is both supporting efficacy data as well as multiple rounds of data affirming its safety."

Answered by AI

To date, how many people have participated in this experiment?

"That is correct. The clinical trial, which began on September 23rd 2020, is still recruiting patients as of October 25th, 2020. They are looking for 788 individuals total from 71 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

2020. "A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04497844.

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