Lifestyle Intervention in Patients With Metastatic Prostate Cancer

Launched by ONCOLOGY INSTITUTE OF SOUTHERN SWITZERLAND · May 5, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how a lifestyle change, which includes a personalized diet and regular exercise, can help men who have recently been diagnosed with metastatic prostate cancer and are receiving hormone therapy. The goal is to see if these changes are practical and beneficial for patients as they manage their treatment.

To join the study, participants need to be at least 18 years old and have a specific type of prostate cancer that is not advancing rapidly. They should also be receiving hormone therapy but not other treatments like chemotherapy. During the trial, participants will follow a tailored diet plan and engage in physical activity, which may help improve their overall health while they continue their cancer treatment. It’s important to note that those with certain health conditions, such as severe heart or lung issues, or those receiving specific cancer treatments, won’t be eligible to participate.

Gender

MALE

Eligibility 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