Lifestyle Intervention in Patients With Metastatic Prostate Cancer
Recruiting · NCT05850182 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Lifestyle intervention
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Oncology Institute of Southern Switzerland (IOSI) - Bellinzona, Switzerland