Lifestyle Intervention in Patients With Metastatic Prostate Cancer
Recruiting now · Not applicable
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT05850182
- Run by
- Oncology Institute of Southern Switzerland
- People needed
- 30
- Starts
- 2023-11-27
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-11-18
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Oncology Institute of Southern Switzerland (IOSI) — Bellinzona, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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