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 Treatme

• Status: NOT_YET_RECRUITING
• Trial end date: 2030-03-31

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.

• Phase: PHASE3

Details

• Lead Sponsor: Alianza multidisciplinar para la investigacin de los tumores genitourinarios -GUARD
• Collaborator: Apices Soluciones S.L.
• Treatments: apalutamide; Docetaxel