Lifestyle changes for men with metastatic prostate cancer
A Pilot Study to Investigate the Effects of Lifestyle Intervention on Physical Activity and Diet in Patients With Metastatic Prostate Cancer Receiving Novel Hormonal Agents: the ACTIDIET-PRO Study
This study is testing whether a personalized diet and exercise plan can help men with newly diagnosed metastatic prostate cancer feel better and manage their condition while they receive treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Oncology Institute of Southern Switzerland Academic / other |
| Locations | 1 site (Bellinzona) |
| Trial ID | NCT05850182 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 18 and older who have been newly diagnosed with adenocarcinoma of the prostate and are receiving androgen deprivation therapy.
Not a fit: Patients with ongoing treatment involving docetaxel or those with evidence of clinical progression or significant cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance the quality of life and potentially improve disease outcomes for patients with metastatic prostate cancer.
How similar studies have performed: While there is existing literature suggesting lifestyle interventions may benefit patients under ADT, conclusive data is lacking, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Bellinzona
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.