Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04734730|
Recruitment Status : Recruiting
First Posted : February 2, 2021
Last Update Posted : August 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Abiraterone Acetate Drug: Bicalutamide Drug: Degarelix Drug: Goserelin Acetate Drug: Leuprolide Acetate Drug: Prednisone Other: Questionnaire Administration Drug: Talazoparib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Talazoparib With Androgen Deprivation Therapy and Abiraterone in Castration Sensitive Prostate Cancer|
|Actual Study Start Date :||May 4, 2021|
|Estimated Primary Completion Date :||December 15, 2023|
|Estimated Study Completion Date :||December 15, 2023|
Experimental: Treatment (talazoparib, androgen deprivation therapy)
Patients receive talazoparib PO QD, abiraterone acetate PO QD, and prednisone PO QD on days 1-28. Patients also receive androgen deprivation therapy consisting of degarelix SC on day 1; 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 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.
Drug: Abiraterone Acetate
Drug: Goserelin Acetate
Drug: Leuprolide Acetate
Other: Questionnaire Administration
- Prostate specific antigen (PSA) nadir < 0.2 [ Time Frame: At 12 months ]Will be estimated with 95% Clopper-Pearson interval.
- Objective response rate [ Time Frame: Up to 2 years ]Will be determined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for patients with measurable disease only, and summarized by % of patients achieving complete response, partial response, stable disease, or progressive disease as best response.
- PSA responses [ Time Frame: Up to 2 years ]Will be described by waterfall plots as recommended by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) as well as identifying the % of patients achieving a 50% and 90% reduction in PSA.
- Radiographic progression-free survival (PFS) [ Time Frame: Up to 2 years ]Will be evaluated for all patients, using RECIST for soft tissue and including the PCWG3 criteria for bone scan assessment of progression of disease. PFS will be carried out by Kaplan-Meier curve and log-rank test will be used to detect difference between groups.
- Patient reported outcomes [ Time Frame: Up to 2 years ]Will be collected using Functional Assessment of Cancer Therapy- Prostate and evaluated for changes from baseline, endpoint will be time to deterioration in quality of life.
- Androgen receptor (AR) genetic variations [ Time Frame: Up to 2 years ]The effect of AR genetic variations on PSA nadir <0.2 at 12 months, ORR, PSA response or PFS. AR CAG and GGC repeats will be analyzed as a continuous variable as well dichotomized as high versus low. PSA nadir results will be compared between CAG/GGC repeat groups.
- Circulating tumor deoxyribonucleic acid (ctDNA) [ Time Frame: At baseline and 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04734730
|United States, California|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Tanya B. Dorff 626-359-8111 email@example.com|
|Principal Investigator: Tanya B. Dorff|
|Principal Investigator:||Tanya B Dorff||City of Hope Medical Center|