Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer
NCT04734730 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2026-01-28
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.
Conditions
- Castration-Sensitive Prostate Carcinoma
- Metastatic Prostate Adenocarcinoma
- Stage IV Prostate Cancer AJCC v8
- Stage IVA Prostate Cancer AJCC v8
- Stage IVB Prostate Cancer AJCC v8
Interventions
- OTHER
-
Questionnaire Administration
Ancillary studies
- DRUG
-
Talazoparib
Given PO
- DRUG
-
Abiraterone Acetate
Given PO
- DRUG
-
Bicalutamide
Given PO
- DRUG
-
Degarelix
Given SC
- DRUG
-
Goserelin Acetate
Given SC
- DRUG
-
Leuprolide Acetate
Given IM
- DRUG
-
Given PO
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
City of Hope Medical Center
lead OTHER
Principal Investigators
-
Tanya Dorff · City of Hope Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-04
- Primary Completion
- 2027-08-23
- Completion
- 2027-08-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
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