OncoMatch/Clinical Trials/NCT04734730
Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer
Is NCT04734730 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for castration-sensitive prostate carcinoma.
Treatment: Abiraterone Acetate · Bicalutamide · Degarelix · Goserelin Acetate · Leuprolide Acetate · Prednisone · Talazoparib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage IV, IVA, IVB
Metastatic disease required
Performance status
KARNOFSKY 60–100
Prior therapy
Must have received: androgen deprivation therapy (LHRH agonist, LHRH antagonist, orchiectomy) — neoadjuvant and/or adjuvant, or in conjunction with salvage radiation
Patients may have received neoadjuvant and/or adjuvant LHRH therapy during definitive treatment or salvage radiation; if so at least 12 months must have elapsed from the last LHRH injection and baseline testosterone must be > 150 ng/dL
Must have received: androgen deprivation therapy (LHRH agonist, LHRH antagonist, orchiectomy) — neoadjuvant and/or adjuvant
Patients may have received prior androgen deprivation therapy (ADT) -neoadjuvant and/or adjuvant, or in conjunction with salvage radiation - but it must not have lasted for more than 36 months. Single or combination therapy allowed. At least 6 months must have elapsed since completion of androgen deprivation therapy in the neoadjuvant and/or adjuvant setting, and serum testosterone must be > 150 ng/mL within 28 days prior to registration.
Cannot have received: ketoconazole, aminoglutethimide, or enzalutamide (ketoconazole, aminoglutethimide, enzalutamide)
Patients must not have received prior and/or must not have any plans for receiving concomitant therapy with ketoconazole, aminoglutethimide, or enzalutamide (MDV3100).
Cannot have received: cytotoxic chemotherapy
Exception: Prior cytotoxic chemotherapy with curative intent in the neoadjuvant or adjuvant setting may be allowed at the discretion of the principal investigator. At least 2 years must have elapsed since completion of cytotoxic chemotherapy in the neoadjuvant and/or adjuvant setting
Patients must not have received any prior cytotoxic chemotherapy for metastatic prostate cancer
Cannot have received: abiraterone, apalutamide, or other intensification agent (abiraterone, apalutamide)
Subjects may not already be taking abiraterone, enzalutamide, apalutamide or other intensification agent during this time - bicalutamide is permitted
Cannot have received: investigational agents, concurrent biological, chemotherapy, or radiation therapy
Exception: Previous experimental therapy must have been completed at least 28 days prior to registration
Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy. Previous experimental therapy must have been completed at least 28 days prior to registration
Lab requirements
Blood counts
Leukocytes ≥ 3,000/mcL; ANC ≥ 1,500/mcL; Hemoglobin ≥ 9 g/dL; Platelets ≥ 100,000/mcL
Kidney function
Calculated creatinine clearance ≥ 30 mL/min
Liver function
Bilirubin ≤ 2 x institutional ULN; AST/ALT ≤ 2.5 x ULN, or ≤ 5 x ULN if liver metastases are present
Bilirubin ≤ 2 x institutional upper limit of normal (ULN)...AST/ALT ≤ 2.5 x institutional ULN, or ≤ 5 x institutional ULN if liver metastases are present...Calculated creatinine clearance ≥ 30 mL/min...Leukocytes ≥ 3,000/mcL...ANC ≥ 1,500/mcL...Hemoglobin ≥ 9 g/dL...Platelets ≥ 100,000/mcL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
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