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.
Written informed consent. Each patient must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures, required for the study, and is willing to participate in the study.
Patient must be a man ≥18 years of age.
Histologically or cytologically confirmed adenocarcinoma of prostate.
Metastatic hormone-sensitive prostate cancer.
Presence of neuroendocrine histology.
Apalutamide treatment started more than 30 weeks before inclusion.
Progression disease by any means, including radiographic, clinical or serological at inclusion.
Patient who achieves deep PSA response on apalutamide treatment before randomization.
Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
Lead sponsor
Apices Soluciones S.L.
Collaborator