NCT05850182Recruiting
Lifestyle Intervention in Patients With Metastatic Prostate Cancer
Summary
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 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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- No phase (N/A)
- Study type
- Interventional
- Countries
- Switzerland
- Sponsor
- Oncology Institute of Southern Switzerland(Other)
- Protocol no.
- ACTIDIET-PRO
- Conditions
- Prostate Cancer
- Interventions
- Behavioral
Treatments studied
- Lifestyle intervention
Locations · 1
- Bellinzona, SwitzerlandOncology Institute of Southern Switzerland (IOSI)Recruiting at this site
In total, worldwide, the only site listed in the registry is recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: November 18, 2025).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.