Taking people in SwitzerlandNo phase
Diet and exercise program for men with metastatic prostate cancer
Tests a diet and activity program in men with prostate cancer.
Key facts
- Who runs it
- Oncology Institute of Southern Switzerland
- Where
- Bellinzona, SwitzerlandSee the site
- Trial code
- Registry title
- Lifestyle Intervention in Patients With Metastatic Prostate Cancer
- Status
- Recruiting
- People taking part
- 30 people, planned
- Started
- 27 Nov 2023
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional
- Treatments tested
- Lifestyle intervention
- Record updated
- 18 November 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer who are on hormone treatment and whose PSA is rising without signs of progression on scans or symptoms. It tests a diet and exercise plan.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Adenocarcinoma of the prostate with rising PSA (two rises of more than 25% above the lowest level, at least three weeks apart) and no clinical or scan progression. PSA doubling time longer than 8 weeks.
- Earlier treatment
- Must be on ADT alone or ADT plus abiraterone, enzalutamide, apalutamide or darolutamide. The treating doctor must find it feasible to continue this treatment.
- Biomarker or test result
- Rising PSA, with PSA doubling time longer than 8 weeks.
Main reasons for not taking part
- Ongoing treatment with docetaxel, cabazitaxel, radionuclides or investigational treatments
- Signs of clinical progression or progression on imaging
- Bone metastases that make physical exercise unsafe
- Severe osteoporosis or other bone disease with a history of fractures
- Significant heart disease or significant chronic obstructive pulmonary disease
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Switzerland
- Oncology Institute of Southern Switzerland (IOSI)Bellinzona, SwitzerlandContact: Ursula Vogl, MDTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Arm treated with lifestyle interventionTreatment being tested
Patients with prostate cancer will receive a lifestyle intervention on diet and physical activity.
Treatment: Lifestyle intervention
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Diet and exercise program for men with metastatic prostate cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 18 November 2025