Lifestyle changes for men with metastatic prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study investigates the feasibility of a lifestyle intervention that combines a personalized dietary regimen with regular physical activity for patients newly diagnosed with metastatic prostate cancer undergoing androgen deprivation therapy (ADT). The study aims to assess how these lifestyle changes can impact the quality of life and disease progression in this patient population. By focusing on modifiable factors such as diet and exercise, the research seeks to provide insights into improving health outcomes for men facing this serious condition.

Why it matters

Who can join: the full rules

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's running

• Oncology Institute of Southern Switzerland (IOSI)
  Bellinzona, Switzerland Recruiting

Study contacts

• Study coordinator: Ursula Vogl, MD
• Email: ursula.vogl@eoc.ch
• Phone: +41 91 811 84 63

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.