Clinical Research Directory

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