Treatment for Metastatic Castration-Sensitive Prostate Cancer and Inherited or Tumor Mutations in DNA Damage Repair Genes (Amplitude)
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]
About the Study
The goal of AMPLITUDE is to see if adding the PARP inhibitor niraparib to standard of care hormone therapy (Abiraterone Acetate, prednisone and androgen deprivation therapy (ADT) is safe and more effective than standard of care alone. The study is enrolling people who have metastatic castration-sensitive prostate cancer and have an inherited or tumor mutation in one of the following genes involved in DNA damage repair: BRCA2, BRCA1, BRIP1, CHEK2, FANCA, PALB2, 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 niraparib plus oral abiraterone, prednisone and androgen deprivation therapy once a day in 28 day cycles
- Group 2 will be given placebo oral abiraterone, prednisone and androgen deprivation therapy once a day in 28 day cycles
Treatment will continue until there is tumor growth or cancer progression or unacceptable toxicity.
Urology Centers Of Alabama
Mayo Clinic Arizona
Urological Associates of Southern Arizona
- Los Angeles
Greater Los Angeles VA Healthcare System
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
- San Bernardino
San Bernardino Urological Associates
- Colorado Springs
Rocky Mountain Cancer Centers
The Urology Center of Colorado
Eastern Connecticut Hematology & Oncology Assoc.
- Daytona Beach
Advanced Urology Institute
University of Florida
Cancer Specialists of North Florida
- New Orleans
Ochsner Clinic Foundation
Maryland Oncology Hematology, PA
Chesapeake Urology Associates
Michigan Institute of Urology
- Saint Joseph
Mosaic Life Care
- St. Louis
St. Louis VA Medical Center
GU Research Network
New York Oncology Hematology
Montefiore Medical Center
- New York
- New York
- New York
Memorial Sloan Kettering Cancer Center
Associated Medical Professionals
- Oklahoma City
Stephenson Cancer Center
VA Portland Health Care System
Keystone Urology Specialists
University of Pennsylvania
University of Pittsburgh Medical Center (UPMC)
Ralph H. Johnson Veterans Affairs Medical Center
Prisma Health Recruiting
Texas Oncology-Denton South
Houston Metro Urology
- New Braunfels
Texas Oncology P.A.
- Salt Lake City
University of Utah Huntsman Cancer Institute
Virginia Oncology Associates
Virginia Commonwealth University - Massey Cancer Center
Seattle Cancer Care Alliance
This Study is Open To:
Men with metastatic castration-sensitive prostate cancer may enroll if they have the following:
- Inherited mutation found on genetic testing or tumor mutation in one of the following genes: BRCA2, BRCA1, BRIP1, CHEK2, FANCA, PALB2, RAD51B and RAD54L. People with mutations in another gene may qualify. Contact study coordinator for additional eligilbility by gene mutation.
- Are receiving androgen deprivation therapy (ADT).
- Certain previous treatments for metastatic prostate cancer are allowed
- maximum of 1 course of radiation and 1 surgical intervention for control of prostate 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 prostate cancer prior to joining study.
This Study is Not Open To:
People are excluded if they:
- Have had prior treatment with a PARP inhibitor.
- Long-term use of corticosteroids.
- Have a history of leukemia.
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.