NCT05850182Recruiting
Lifestyle Intervention in Patients With Metastatic Prostate Cancer
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
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 24 Apr 2023
- Start date
- 27 Nov 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Oncology Institute of Southern Switzerland
- Diseases
- Prostate cancer
- NCT number
- NCT05850182
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 27 Nov 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Evidence of clinical progression or progression of disease on imaging
- Clinically significant chronic obstructive pulmonary disease
Other
- Bone metastases excluding the safety of physical exercise
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oncology Institute of Southern Switzerland (IOSI) Coordinator of this site? Confirm its status | Bellinzona | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.