Lifestyle Intervention in Patients With Metastatic Prostate Cancer

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

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

Conditions2

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