About this trial
Italian multicenter study, will enroll \~566 pts with oligometastatic hormone sensitive prostate cancer who are candidates to receive treatment with apalutamide.
After 6 months from the start of treatment, patients will be randomized to receive local treatment based on the investigator's choice ( either one between primary radiotherapy or cytoreductive prostatectomy), in addition to apalutamide, or to continue just with medical therapy.
Eligibility criteria
Qualifiers
Age > 18
Histologically confirmed diagnosis of prostate adenocarcinoma
Metastatic disease documented by ≥1 bone lesion with Technetium 99m (99mTc) bone scan. Individuals with only one bone lesion should have confirmation of that lesion on CT or MRI.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) Grade ≤ 2
Disqualifiers
Pathologic findings consistent with small cell, ductal, or neuroendocrine prostate cancer.
Known brain metastases.
Lymph node metastases only.
Visceral metastases.
Trial design
Treatments tested in this trial
- APA + ADT
- Local Treatmetn RT or RP
Treatment groups
Sponsors and collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead sponsor
ASST Santi Paolo e Carlo
Collaborator
European Institute of Oncology
Collaborator