Lifestyle intervention: 12-week lifestyle intervention including adherence to a personalized balanced dietary regimen (low total fat, low saturated fat, high ω3 fatty acids, optimized protein content, low simple sugars) combined with regular physical activity (including physiotherapy sessions and self-training).
Study 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
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Patient initiation rate — 12 weeks Study initiation rate (total number of patients enrolled divided by the number of patients screened for the study)
Patient retention rate — 12 weeks Retention rate (number of patients completing the study divided by total number of patients enrolled at baseline)
Adherence to prescribed training program — 12 weeks Adherence rate (fraction of scheduled physical activity appointments/selftrainings attended/carried out by the patients)
Adherence to prescribed dietary regimen — 12 weeks Adherence rate (fraction of days of adherence to the prescribed dietary regimen)
Trial sites (1)
Facility
City
Region
Status
Oncology Institute of Southern Switzerland (IOSI)
Bellinzona
Switzerland
Recruiting
More Oncology Institute of Southern Switzerland trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.