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.

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.

NCT Number	NCT07333066
Lead Sponsor	Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD Collaborators: Apices Soluciones S.L.
Conditions	Metastatic Hormone-sensitive Prostate Cancer
Enrollment	320 participants
Start Date	2026-06-05
Primary Completion	2030-03-31 (estimated)
Study Completion	2030-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-17