Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents (EvoPAR-PR01)
https://www.facingourrisk.org/research-clinical-trials/study/339/studying-the-effectiveness-of-new-parp-inhibitor-saruparib-compared-to-current-treatment-options-for-metastatic-prostate-cancer-evopar-pro1
Clinicaltrials.gov identifier:
NCT06120491 (https://clinicaltrials.gov/show/NCT06120491)
Treatment
Treatment study for metastatic, castration-sensitive prostate cancer
Study Contact Information:
For additional information, please contact:
AstraZeneca Clinical Study Information Center
1-877-240-9479 or information.center@astrazeneca.com
Principal Investigator: Kim Nguyen Chi, MD, BC Cancer, Canada
Principal Investigator: Arun Azad, MD, Peter MacCallum Cancer Centre, Australia
About the Study
The current standard treatment for metastatic prostate cancer is the use of new hormonal agents (NHA) Zytiga (abiraterone acetate), Nubequa (darolutamide) or Xtandi (enzalutamide). This study will evaluate an investigational PARP inhibitor drug called Saruparib in combination with new hormonal agents in the treatment of metastatic prostate cancer, compared to the current standard treatment available. The study will enroll people whose tumors have mutations in the following genes: BRCA1, BRCA2, ATM, BARD1, CDK12, PALB2, RAD51B, RAD51C, RAD51D.
The study's goal is to learn whether the addition of the study drug, Saruparib, is more effective at stopping the growth of metastatic prostate cancer. The study will measure the average amount of time without tumor growth through regular imaging in people on the new drug and those on standard NHA treatment. Neither the providers nor the people enrolling will be informed of which treatment group they are assigned to.
What the Study Involves
People enrolled in the study will be randomly assigned to one of two groups:
Group 1: - will receive standard therapy with one of the new hormonal agents: Zytiga (abiraterone acetate), Nubequa (darolutamide), or Xtandi (enzalutamide) and the new drug, saruparib.
Group 2: will receive standard therapy with one of the new hormonal agents: Zytiga (abiraterone acetate); Nubequa (darolutamide); Xtandi (enzalutamide) and a placebo
Both the new drug, the placebo, and the hormonal therapies are taken orally. Both groups will continue with regular treatment and imaging scans until the end of the study, or until treatment is stopped.
This Study is Open To:
People 18 years or older, who meet the following:
- castration-sensitive prostate cancer
- metastatic disease
- have not received treatment in the metastatic setting (with some exceptions)
- have one of the following mutations in their tumor found by tumor testing or liquid biopsy:
- BRCA1, BRCA2, ATM, BARD1, CDK12, PALB2, RAD51B, RAD51C, RAD51D
This Study is Not Open To:
People cannot participate if they:
- had previous treatment or surgery for metastatic prostate cancer, with exceptions. Contact the study team for further details.
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.