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
I. Increase the efficacy of first-line therapy for men with metastatic castration-sensitive
prostate cancer by adding the PARP inhibitor talazoparib to standard therapy with androgen
deprivation therapy (ADT) + abiraterone acetate (abiraterone).
II. Study the efficacy of abiraterone and talazoparib in an ethnically diverse population.
III. Evaluate whether androgen receptor genetic variation may identify a subpopulation of
patients who benefit, even in the absence of homologous repair deficiency mutations.
Patients receive talazoparib orally (PO) once daily (QD), abiraterone acetate PO QD, and
prednisone PO QD on days 1-28. Patients also receive androgen deprivation therapy consisting
of degarelix subcutaneously (SC) on day 1; leuprolide acetate intramuscularly (IM) on day 1
and bicalutamide PO QD on days 1-28 of cycle 1 and then leuprolide acetate IM on day 1 of
subsequent cycles; leuprolide acetate IM on day 1 and bicalutamide PO QD on days 1-28 of
cycle 1 and then leuprolide acetate IM on day 1 of cycles 2, 5, 8, and 11; or goserelin
acetate SC monthly or every 3 months. Cycles repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
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
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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