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Studying the Effectiveness of New PARP Inhibitor, Saruparib Compared to Current Treatment Options for Metastatic Prostate Cancer EvoPAR-PRO1

Clinicaltrials.gov identifier:
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

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

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.

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.

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Contact Info:
No contact info provided

Country: Japan
City: Suita-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Japan
City: Tsu-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Japan
City: Yokohama-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Japan
City: Yufu-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Korea, Republic of
City: Daejeon RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Korea, Republic of
City: Seongnam-si RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Korea, Republic of
City: Seoul RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Korea, Republic of
City: Suwon RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Malaysia
City: George Town RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Malaysia
City: Johor Bahru RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Malaysia
City: Kota Kinabalu RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Malaysia
City: Kuala Lumpur RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Malaysia
City: Kuching RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Netherlands
City: Amsterdam RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Netherlands
City: Hilversum RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Netherlands
City: Nijmegen RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Peru
City: Arequipa RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Peru
City: Bellavista RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Peru
City: Lima RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Poland
City: Bydgoszcz RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Poland
City: Koszalin RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Poland
City: Poznań RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Poland
City: Rzeszów RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Poland
City: Warszawa RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Poland
City: Wrocław RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Spain
City: Barcelona RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Spain
City: Córdoba RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Spain
City: L'Hospitalet de Llobregat RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Spain
City: Lugo RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Spain
City: Madrid RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Spain
City: Sabadell RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Spain
City: Valencia RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Taiwan
City: Kaohsiung RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Taiwan
City: Kaohsiung city RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Taiwan
City: Taichung RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Taiwan
City: Taoyuan RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Taiwan
City: Yung Kang City RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Thailand
City: Bangkok RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Thailand
City: Chiang Mai RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Thailand
City: Khlong Luang RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Thailand
City: Songkla RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Turkey
City: Ankara RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Turkey
City: Bornova-Izmir RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Turkey
City: Fatih-Istanbul RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Turkey
City: Istanbul RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Turkey
City: Karsiyaka RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: United Kingdom
City: Aberdeen RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: United Kingdom
City: Birmingham RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: United Kingdom
City: Cambridge RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: United Kingdom
City: Glasgow RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: United Kingdom
City: Guildford RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: United Kingdom
City: London RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: United Kingdom
City: Manchester RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: United Kingdom
City: Newcastle upon Tyne RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: United Kingdom
City: Oxford RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: United Kingdom
City: Plymouth RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: United Kingdom
City: Preston RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: United Kingdom
City: Truro RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

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.