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.

Sponsor
Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
Study ID
NCT07333066
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Metastatic Hormone-sensitive Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apalutamide (Erleada™) 60 mg or 240 mg tablets — DRUG
    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.
  • Docetaxel — DRUG
    The recommended dose of docetaxel is 75 mg/m2 day 1 every 21 days. Six cycles of docetaxel will be administered.

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Dec 2025
Primary completion
Mar 31, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (experimental arm)
    Docetaxel (75 mg/m2 every three weeks), for 6 planned cycles, plus apalutamide (240 mg, oral single daily dose) and ADT.
  • No Intervention: Arm B (control arm)
    Continuation of SOC treatment with apalutamide (240 mg, oral single daily dose) and ADT.

Primary Outcome Measure

Event-free Survival (EFS) [ Time Frame: 48 months ]

Central Contacts

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