Lifestyle Intervention in Patients With Metastatic Prostate Cancer
Key facts
- Where
- Bellinzona, SwitzerlandSee the site
Where in Switzerland
- Oncology Institute of Southern Switzerland (IOSI)Bellinzona, SwitzerlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oncology Institute of Southern Switzerland
- Trial code
- NCT05850182
- Record updated
- 18 November 2025
- Original description
The proposed pilot study aims at determining the feasibility of a lifestyle intervention including adherence to a personalised dietary regimen combined with regular physical activity in patients newly diagnosed with prostate cancer under androgen deprivation therapy.Read full original descriptionShow less
A Pilot Study to Investigate the Effects of Lifestyle Intervention on Physical Activity and Diet in Patients With Metastatic Prostate Cancer Receiving Novel Hormonal Agents: the ACTIDIET-PRO Study
The proposed pilot study aims at determining the feasibility of a lifestyle intervention including adherence to a personalised dietary regimen combined with regular physical activity in patients newly diagnosed with prostate cancer under androgen deprivation therapy.
Inclusion: 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: Ongoing treatment with docetaxel, cabazitaxel, radionuclides or investigational treatments; 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); Any concurrent disease or comorbid condition that interferes with the ability of the patient to participate in the study; Evidence of clinical progression or progression of disease on imaging; Clinically significant chronic obstructive pulmonary disease; Bone metastases excluding the safety of physical exercise.