NCT07333066

Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, randomized, open-label, multi-center study to assess the efficacy of treatment intensification with docetaxel plus apalutamide and ADT, assessed by event-free survival, in patients with mHSPC who do not achieve deep PSA response (≤0,2 ng/ml or PSA90 response in combination with a PSA ≤ 4 ng/ml) after initial treatment with apalutamide and ADT. A non-deep PSA response is defined as PSA \> 0.2 ng/ml in combination with a PSA response \< 90%, or a PSA response ≥90% in combination with a PSA \> 4 ng/ml.

Detailed description

Approximately 320 patients will be randomized in a 1:1 ratio to the treatments as specified below: * Arm A (experimental arm): docetaxel (75 mg/m2 every three weeks), for 6 planned cycles, plus apalutamide and ADT (240 mg, oral single daily dose). * Arm B (control arm): continuation of SOC treatment with apalutamide and ADT (240 mg, oral single daily dose). Randomization will be stratified by 3 factors: * Metastasis timing (synchronous vs metachronous) * Visceral metastasis at diagnosis (yes vs no) * PSA at study inclusion (≤ 4 ng/ml vs \>4 ng/ml) An IDMC will be established for regular safety monitoring, for the pre-planned interim analysis and the PK sub-study when available. The composition, role, responsibilities and procedures of the IDMC will be detailed in the IDMC Charter.

Conditions

• Metastatic Hormone-sensitive Prostate Cancer

Interventions

Type	Name	Description
DRUG	Apalutamide (Erleada™) 60 mg or 240 mg tablets	The dose of 240 mg (four 60 mg tablets or one single 240 mg tablet) daily of apalutamide is the recommended dose in the SmPC. ADT will be chosen and administered according to standard clinical practice at each participating site and has not been included in the table below.
DRUG	Docetaxel	The recommended dose of docetaxel is 75 mg/m2 day 1 every 21 days. Six cycles of docetaxel will be administered.

Timeline

• Start date: 2026-03-31
• Primary completion: 2030-03-31
• Completion: 2030-03-31
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

56 sites across 5 countries: France, Germany, Italy, Portugal, Spain