Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

PRIMARY OBJECTIVES: 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. OUTLINE: 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04734730
Study type Interventional
Source City of Hope Medical Center
Contact
Status Recruiting
Phase Phase 2
Start date May 4, 2021
Completion date August 23, 2027

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04716725 - 68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer Phase 2
Withdrawn NCT05034562 - Gallium-68 PSMA-11 PET in Participants With Prostate Cancer Phase 2
Recruiting NCT03678025 - Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer Phase 3
Active, not recruiting NCT03218826 - PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery Phase 1
Active, not recruiting NCT04033432 - sEphB4-HSA in Treating Patients With Metastatic Castration-Resistant Prostate Cancer Phase 2
Active, not recruiting NCT05496959 - 177-Lutetium-PSMA Before Stereotactic Body Radiotherapy for the Treatment of Oligorecurrent Prostate Cancer, The LUNAR Study Phase 2
Terminated NCT04134208 - An Investigational Scan (18F-Fluciclovine PET-CT) for the Measurement of Therapeutic Response in Patients With Metastatic Prostate Cancer Phase 4
Not yet recruiting NCT06236139 - Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer Phase 1/Phase 2
Recruiting NCT04423211 - Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging Phase 3
Completed NCT04976257 - Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion Early Phase 1
Withdrawn NCT04585932 - Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study Phase 2
Active, not recruiting NCT05241860 - Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM) Phase 2
Recruiting NCT04159896 - ESK981 and Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer Phase 2
Recruiting NCT04314401 - National Cancer Institute "Cancer Moonshot Biobank"
Completed NCT05547386 - 68Ga-PSMA-11 PET/CT Screening Prior to 177Lu-PSMA-617 Therapy for Patients With Metastatic Castrate Resistant Prostate Cancer Phase 3
Recruiting NCT06200103 - Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer Phase 2
Recruiting NCT06039371 - Supraphysiological Androgen to Enhance Chemotherapy Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study Phase 2
Recruiting NCT03866382 - Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors Phase 2
Active, not recruiting NCT04267887 - Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer Phase 2
Recruiting NCT05730712 - Pertuzumab, Trastuzumab, Hyaluronidase-zzxf and Enzalutamide for Treatment of Metastatic Castration-Resistant Prostate Cancer Phase 2