RecruitingPhase 2NCT04734730

Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer

Phase II Study of Talazoparib With Androgen Deprivation Therapy and Abiraterone in Castration Sensitive Prostate Cancer


Sponsor

City of Hope Medical Center

Enrollment

70 participants

Start Date

May 4, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies the effect of talazoparib with androgen deprivation therapy and abiraterone in treating castration sensitive prostate cancer patients. Talazoparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Androgen can cause the growth of prostate tumor cells. Degarelix, leuprolide acetate, bicalutamide, goserelin acetate, and abiraterone lowers the amount of androgen made by the body. This may help stop the growth of tumor cells that need androgen to grow. Giving talazoparib with androgen deprivation therapy and abiraterone may improve cancer control for patients with castration sensitive prostate cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a PARP inhibitor drug (talazoparib) to standard hormone-blocking therapy (androgen deprivation therapy plus abiraterone) helps men with newly metastatic prostate cancer that still responds to hormone treatment. **You may be eligible if...** - You have been diagnosed with prostate cancer that has spread to other parts of the body (bones or soft tissue) - Your cancer has not yet been treated with hormone therapy, or you started it very recently - Your diagnosis was confirmed by biopsy - You have adequate organ function and blood counts **You may NOT be eligible if...** - Your prostate cancer no longer responds to hormone therapy (castration-resistant) - You have had prior chemotherapy for prostate cancer - You have certain genetic conditions (like myelodysplastic syndrome) - You have significant heart or liver problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbiraterone Acetate

Given PO

DRUGBicalutamide

Given PO

DRUGDegarelix

Given SC

DRUGGoserelin Acetate

Given SC

DRUGLeuprolide Acetate

Given IM

DRUGPrednisone

Given PO

OTHERQuestionnaire Administration

Ancillary studies

DRUGTalazoparib

Given PO


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT04734730


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