NCT05850182 Lifestyle Intervention in Patients With Metastatic Prostate Cancer
| NCT ID | NCT05850182 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oncology Institute of Southern Switzerland |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-11-27 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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Brief 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.
Eligibility Criteria
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
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