Trial intelligence / Profile preview

Enzalutamide and Talazoparib in metastatic hormone-naïve prostate cancer

NCT04332744Phase 2

Key facts

Status: Completed
Start: Sep 2020
Primary completion: May 2025
Countries: 1
Sponsor: MEDSIR
Modality: Small Molecules

Drugs: talazoparib
Conditions: prostate cancer (PCa)

Overview

Phase 2, randomised, open-label trial of talazoparib in prostate cancer (PCa) (2 arms), sponsored by MEDSIR. Primary endpoint: Prostate specific antigen complete response at 12 months. Started Sep 2020; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Control Arm (Arm A)
Enzalutamide + ADT
Interventional Arm (Arm B)
Enzalutamide + Talazoparib + ADT

Who it enrols

Men aged 18 or older with high-volume, histologically confirmed metastatic hormone-naïve prostate adenocarcinoma (mHNPC) and an ECOG status of 0-1. Patients must not have received prior systemic therapy for mHNPC and must have adequate organ function.

Endpoints

Primary

Prostate specific antigen complete response12 months

Secondary

Prostate specific antigen complete response7 months
Prostate specific antigen response12 months
Time to Clinical Progression12 months
Prostate-Specific Antigen progression of disease12 months
Prostate-Specific Antigen progression-free survival12 months
Radiological progression-free survival12 months
Time to development of castration resistant prostate cancer12 months
Overall survival12 months

Beyond the preview

Go deeper on NCT04332744.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT04332744.