M.D. Anderson Cancer Center
To learn about the effectiveness of adding talazoparib to the standard of care treatment combination of androgen ablation therapy (hormone therapy, also known as ADT) and enzalutamide in patients with prostate cancer that has spread into the lymph nodes.
Prostate Cancer
ADT
Enzalutamide
Talazoparib
Degarelix
Leuprolide
Phase 2
Primary Objective: •To evaluate the antitumor activity of presurgical talazoparib (PF-06944076) in combination with enzalutamide and androgen deprivation therapy (ADT) followed by surgery, in patients newly diagnosed with prostate cancer metastatic to lymph nodes (TxN1M0, TxNxM1a), as determined by the proportion of patients with undetectable prostate-specific antigen (PSA) 1 year after surgery. Secondary Objectives: Analyze pathologic response in the primary tumor and metastatic lymph nodes to talazoparib in combination with enzalutamide and ADT in this population. Analyze 5-year disease-free survival and 5-year metastasis-free survival after talazoparib in combination with enzalutamide and ADT followed by surgical consolidation in this population. Evaluate the safety and tolerability of presurgical talazoparib in combination with enzalutamide and ADT in this population. Evaluate induction of a conditional homologous recombination deficient (HRD) state after 2 mos. of ADT and enzalutamide treatment relative to clinical and pathological outcomes. Exploratory Objectives: To evaluate predictive and/or prognostic genomic and transcriptomic biomarkers associated with response to treatment or disease progression. To correlate data on intra-patient genomic heterogeneity from tumor biopsies and data from functional imaging with clinical benefit endpoints. To study possible mechanisms of resistance to study treatments through the comparative analysis of candidate biomarkers from paired pre-treatment, on therapy, and post-therapy tumor tissue.}}
Study Type : | Interventional |
Estimated Enrollment : | 30 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in de Novo Metastatic to Lymph Nodes Prostate Cancer |
Actual Study Start Date : | September 30, 2024 |
Estimated Primary Completion Date : | December 31, 2026 |
Estimated Study Completion Date : | December 31, 2028 |
Arm | Intervention/treatment |
---|---|
Experimental: ADT plus Enzalutamide plus Talazoparib Participant will receive ADT plus Enzalutamide for a total of 8 weeks. After about 8 weeks of ADT and Enzalutamide treatment, participant will begin taking Talazoparib |
Drug: ADT Drug: Enzalutamide Drug: Talazoparib Drug: Degarelix Drug: Leuprolide |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
M D Anderson Cancer Center
Houston, Texas, United States, 77030