Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC

Official Title

TALAPRO-3: a phase 3, randomized, double-blind, study of talazoparib with enzalutamide versus placebo with enzalutamide in men with DDR gene mutated metastatic castration-sensitive prostate cancer

Summary:

The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.

Trial Description

Primary Outcome:

• radiological Progression-Free Survival

Secondary Outcome:

• Overall Survival
• Objective response in measurable soft tissue disease
• Duration of response in measurable soft tissue disease
• Prostate Specific Antigen (PSA) response
• Time to PSA progression
• Time to initiation of antineoplastic therapy
• Time to first symptomatic skeletal event
• Opiate use for prostate cancer pain
• Incidence of adverse events
• Pharmacokinetic assessment of talazoparib
• Pharmacokinetic assessment of enzalutamide and its metabolite
• Relationship between ctDNA burden and outcome
• Patient-reported outcomes in pain symptoms - change from baseline
• Patient-reported outcomes in pain symptoms - time to deterioration
• Patient-reported outcomes in cancer specific general health status - change from baseline
• Patient-reported outcomes in cancer specific global health status/QoL - change from baseline
• Patient-reported outcomes in cancer specific global health status/QoL - time to definitive deterioration
• Patient-reported outcomes in cancer specific symptoms - time to definitive deterioration
• Patient-reported outcome: cancer specific functioning, and symptoms - change from baseline

The study will have 5 periods: prescreening, screening, double-blind treatment, safety follow-up, and long-term follow-up. Approximately 550 men with mCSPC will be randomized. Eligible participants will be randomly assigned to either of 2 treatment groups as follows:

• Talazoparib in combination with enzalutamide.

• Placebo capsules identical in appearance to talazoparib capsules in combination with enzalutamide. Talazoparib or identical placebo treatment will be blinded. Enzalutamide (160 mg/day) will be open label. The dose of talazoparib/placebo to be given in combination with enzalutamide is 0.5 mg once daily. Participants with moderate renal impairment (eGFR 30-59 mL/min/1.73 m2 by the MDRD equation) at screening may be enrolled and the talazoparib/placebo dose will be 0.35 mg once daily.

View this trial on ClinicalTrials.gov