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.
Parallel
Apalutamide (Erleada™) 60 mg or 240 mg tablets
DrugThe 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
DrugThe recommended dose of docetaxel is 75 mg/m2 day 1 every 21 days. Six cycles of docetaxel will be administered.
Event-free Survival (EFS)
Event-free survival is defined as the time from randomization to occurrence of the following events, whichever occurs first in each treatment arm: PSA progression or radiographic progression of soft-tissue, visceral, or bone lesions or death from any cause.
Time to castration resistance
Time to castration resistance is defined as time from randomization to radiographic disease progression, PSA progression per PCWG3 criteria, or symptomatic skeletal event (defined as radiation to bone, pathologic fracture, spinal cord compression, or surgery to bone due to symptoms), whichever occurred first in each treatment arm.
Radiographic progression-free survival (rPFS)
Radiographic Progression-Free Survival is defined as the time from randomization to the first documented evidence of radiographic disease progression, as assessed by the investigator per Prostate Cancer Working Group 3 (PCWG3) criteria for bone lesions and RECIST v1.1 for soft tissue lesions, or death from any cause, whichever occurs first in each treatment arm.
PSA progression-free survival
PSA progression-free survival (PSA-PFS) is defined according to PCWG3 criteria as the time from randomization to the date of PSA progression (a ≥25% increase and an absolute increase of ≥2 ng/mL from nadir, confirmed by a second value ≥3 weeks later) or death from any cause, whichever occurs first in each treatment arm.
Overall survival
Overall survival is defined as time from randomization to date of death from any cause in each treatment arm.
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Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
Lead sponsor
Apices Soluciones S.L.
Collaborator
