Lifestyle Intervention in Patients With Metastatic Prostate Cancer (ACTIDIET-PRO)

Inclusion Criteria: Written informed consent according to ICH/GCP regulations before registration. Age ≥ 18 years Histology of adenocarcinoma of the prostate Patients with PCa receiving ADT alone or ADT+NHT (abiraterone, enzalutamide, apalutamide or darolutamide) Rising PSA (two consecutively rising PSA levels > 25% above nadir at least three weeks apart), with no evidence of clinical or radiographic progression on instrumental evaluation PSA doubling time > 8 weeks Continuation of ongoing systemic treatment is deemed feasible by treating physician Exclusion Criteria: Ongoing treatment with docetaxel, cabazitaxel, radionuclides or investigational treatments Evidence of clinical progression or progression of disease on imaging Bone metastases excluding the safety of physical exercise Prior confirmed severe osteoporosis or other diseases affecting the bone with history of fractures Clinically significant cardiovascular disease (i.e. myocardial infarction within 6 months before screening; uncontrolled angina within 3 months before screening; congestive heart failure New York Heart Association class 3 or 4; history of clinically significant arrhythmias; uncontrolled hypertension indicated by systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg at screening) Clinically significant chronic obstructive pulmonary disease Any concurrent disease or comorbid condition that interferes with the ability of the patient to participate in the study