Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in de Novo Metastatic to Lymph Nodes Prostate Cancer
M.D. Anderson Cancer Center
Summary
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.
Description
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 disea…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients with adenocarcinoma of the prostate that in the opinion of the urologist could be resected after response to systemic therapy. Ductal adenocarcinoma is permitted. 2. Patients must be regarded as acceptable surgical risk and confirm their intention to undergo radical prostatectomy at the end of the pre-surgical therapy. 3. ECOG performance status 2 or better. 4. All patients must have tumor staging and meet at least one of the following criteria: 1. Either lymph node biopsy or lymph node dissection demonstrating lymph node metastasis by prostate cancer. 2…
Interventions
- DrugADT
Given by PO
- DrugEnzalutamide
Given by PO
- DrugTalazoparib
Given by PO
- DrugDegarelix
Given PO or given INJ
- DrugLuprolide
Given PO or given INJ
Location
- M D Anderson Cancer CenterHouston, Texas