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REINFORCE: Docetaxel Plus Apalutamide in mHSPC Patients Without Deep PSA Response

NCT07333066Phase 3

Key facts

Status: Recruiting
Start: Jun 2026
Primary completion: Mar 2030
Countries: 5
Modality: Small Molecules

Drugs: docetaxel
Conditions: prostate cancer (PCa)

Overview

Phase 3, randomised, open-label trial of docetaxel in prostate cancer (PCa) (2 arms). Primary endpoint: Event-free Survival at 48 months. Started Jun 2026; status: recruiting.

Design

2 arms

Study design: RandomizedOpen-label

Arm A (experimental arm)
Docetaxel + apalutamide + ADT
Arm B (control arm)
Apalutamide + ADT

Who it enrols

Adult men with metastatic hormone-sensitive prostate cancer who have received 24-30 weeks of apalutamide and ADT but did not achieve a deep PSA response, without disease progression, and with adequate organ function.

Endpoints

Primary

Event-free Survival48 months

Secondary

Time to castration resistance48 months
Radiographic progression-free survival48 months
PSA progression-free survival48 months
Overall survival48 months
Time to subsequent treatment48 months
Deep PSA response rate6 months
Ultradeep PSA response rate6 months
Symptomatic skeletal event-free survival48 months

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