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Treatment for Metastatic Castration-Sensitive Prostate Cancer and Inherited or Tumor Mutations in DNA Damage Repair Genes (Amplitude)
https://www.facingourrisk.org/research-clinical-trials/study/209/treatment-for-metastatic-castration-sensitive-prostate-cancer-and-inherited-or-tumor-mutations-in-dna-damage-repair-genes-amplitude
Clinicaltrials.gov identifier:
NCT04497844 (https://clinicaltrials.gov/show/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]
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.
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
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 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.
About FORCE
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.
