Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05873192
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact	Amado Zurita-Saavedra, MD
Phone	(713) 563-6966
Email	azurita@mdanderson.org
Status	Not yet recruiting
Phase	Phase 2
Start date	September 30, 2024
Completion date	December 31, 2028

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms