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Treatment for Metastatic Castration-Sensitive Prostate Cancer and Inherited or Tumor Mutations in DNA Damage Repair Genes (Amplitude)

Clinicaltrials.gov identifier:
NCT04497844

Treatment
Treatment for metastatic castration-sensitive prostate cancer and a tumor or inherited mutation in BRCA1, BRCA2, ATM, BRIP1, CHEK2, PALB2 or related gene

Study Contact Information:

For additional information, please contact:
Janssen study contact at:
844-434-4210 or via email at: [email protected]

Treatment for Metastatic Castration-Sensitive Prostate Cancer and Inherited or Tumor Mutations in DNA Damage Repair Genes (Amplitude)

About the Study

The goal of AMPLITUDE is to see if adding the niraparib to standard of care hormone therapy (Abiraterone Acetate, prednisone and (ADT) is safe and more effective than standard of care alone. The study is enrolling people who have castration-sensitive cancer and have an inherited or tumor mutation in one of the following genes involved in damage repair: , , , , FANCA, , RAD51B and RAD54L.

What the Study Involves

Participants will be randomly assigned into one of two groups. Participants in each group will receive different drug combinations. Participants are monitored for time until their cancer comes back or grows larger (progression-free survival) for up to 78 months (about 6.5 years). 

  • Group 1 will receive oral plus oral abiraterone, prednisone and  once a day in 28 day cycles
  • Group 2 will be given  oral abiraterone, prednisone and  once a day in 28 day cycles

Treatment will continue until there is tumor growth or cancer progression or unacceptable . 

Study Sites

Alabama

  • Homewood
    Urology Centers Of Alabama

Arizona

  • Phoenix
    Mayo Clinic Arizona
  • Tucson
    Urological Associates of Southern Arizona

California

  • Los Angeles
    Greater Los Angeles VA Healthcare System
  • Orange
    University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
  • San Bernardino
    San Bernardino Urological Associates

Colorado

  • Colorado Springs
    Rocky Mountain Cancer Centers
  • Denver
    The Urology Center of Colorado
  • Lakewood
    Foothills Urology

Connecticut

  • Norwich
    Eastern Connecticut Hematology & Oncology Assoc.

Florida

  • Daytona Beach
    Advanced Urology Institute
  • Jacksonville
    University of Florida
  • Jacksonville
    Cancer Specialists of North Florida

Indiana

  • Jeffersonville
    First Urology

Louisiana

  • New Orleans
    Ochsner Clinic Foundation

Maryland

  • Columbia
    Maryland Oncology Hematology, PA
  • Towson
    Chesapeake Urology Associates

Michigan

  • Troy
    Michigan Institute of Urology

Missouri

  • Saint Joseph
    Mosaic Life Care
  • St. Louis
    St. Louis VA Medical Center

Nebraska

  • Omaha
    GU Research Network

New York

  • Albany
    New York Oncology Hematology
  • Bronx
    Montefiore Medical Center
  • New York
    Manhattan VAMC
  • New York
    Mount Sinai
  • New York
    Memorial Sloan Kettering Cancer Center
  • Syracuse
    Associated Medical Professionals

North Carolina

  • Durham
    Durham VAMC

Oklahoma

  • Oklahoma City
    Stephenson Cancer Center

Oregon

  • Portland
    VA Portland Health Care System

Pennsylvania

  • Lancaster
    Keystone Urology Specialists
  • Philadelphia
    University of Pennsylvania
  • Pittsburgh
    University of Pittsburgh Medical Center (UPMC)

South Carolina

  • Charleston
    Ralph H. Johnson Veterans Affairs Medical Center
  • Seneca
    Prisma Health Recruiting

Tennessee

  • Nashville
    Urology Associates

Texas

  • Denton
    Texas Oncology-Denton South
  • Houston
    Houston Metro Urology
  • New Braunfels
    Texas Oncology P.A.
  • Tyler
    Texas Oncology-Tyler

Utah

  • Salt Lake City
    University of Utah Huntsman Cancer Institute

Virginia

  • Norfolk
    Virginia Oncology Associates
  • Richmond
    Virginia Commonwealth University - Massey Cancer Center

Washington

  • Seattle
    Seattle Cancer Care Alliance
This Study is Open To:

Men with castration-sensitive cancer may enroll if they have the following:

  • Inherited mutation found on genetic testing or tumor mutation in one of the following genes: , , , , FANCA, , RAD51B and RAD54L. People with mutations in another gene may qualify. Contact study coordinator for additional eligilbility by gene mutation.
  • Are receiving (ADT).
  • Certain previous treatments for prostate cancer are allowed 
    • maximum of 1 course of radiation and 1 surgical intervention for control of cancer symptoms.
    • Up to a maximum of 6 months of ADT prior to joining study. 
    • Up to a maximum of 45 days of abiraterone acetate + prednisone (AA-P) prior to joining study. 
    • Up to a maximum of 2 weeks of ketoconazole for cancer prior to joining study.
This Study is Not Open To:

People are excluded if they:

  • Have had prior treatment with a .
  • Long-term use of corticosteroids.
  • Have a history of leukemia.