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Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents (EvoPAR-PR01)

Treatment

Treatment study for metastatic, castration-sensitive prostate cancer

Clinicaltrials.gov identifier:
NCT06120491

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

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About the Study

The current standard treatment for prostate cancer is the use of new hormonal agents (NHA) Zytiga ( acetate), Nubequa (darolutamide) or Xtandi (). This study will evaluate an investigational drug called Saruparib in combination with new hormonal agents in the treatment of prostate cancer, compared to the current standard treatment available. The study will enroll people whose tumors have mutations in the following genes: , , , , CDK12, , RAD51B, , .

The study's goal is to learn whether the addition of the study drug, Saruparib, is more effective at stopping the growth of 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.

This Study is Open To:

People 18 years or older, who meet the following:

  • disease
  • have not received treatment in the setting (with some exceptions)
  • have one of the following mutations in their tumor found by tumor testing or liquid biopsy:
    • , , , , CDK12, , RAD51B, ,

This Study is NOT Open To:

People cannot participate if they:

  • had previous treatment or surgery for prostate cancer, with exceptions. Contact the study team for further details.

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 ( acetate), Nubequa (darolutamide), or Xtandi () and the new drug, saruparib.

Group 2: will receive standard therapy with one of the new hormonal agents: Zytiga ( acetate); Nubequa (darolutamide); Xtandi () and a

Both the new drug, the , 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.

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

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Treatment

Treatment study for metastatic, castration-sensitive prostate cancer

Clinicaltrials.gov identifier:
NCT06120491

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

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