Lifestyle Intervention in Patients With Metastatic Prostate Cancer (ACTIDIET-PRO)

Oncology Institute of Southern Switzerland (IOSI)

Status

Enrolling

Conditions

Prostate Cancer

Treatments

Behavioral: Lifestyle intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05850182

ACTIDIET-PRO

Details and patient eligibility

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.

Full description

Prostate cancer (PCa) is among the most frequent tumor types and is the second deadliest type of cancer in men.

PCa has a multifactorial aetiology; modifiable environmental factors, including diet and obesity, have been associated with prostate carcinogenesis. Furthermore, patients with PCa are treated with androgen deprivation therapy (ADT), which has negative effects on the cardiovascular system and body composition, particularly on the fat and muscle mass, bone health and psychological wellbeing.

Data in the current literature suggests that a lifestyle intervention e.g. with targeted and supervised exercise therapy or a dietary intervention with a prudent dietary patternmay positively influence the quality of life and the course of the disease of patients under ADT. However, conclusive data is missing.

The proposed pilot study aims at determining the feasibility and the effect of a lifestyle intervention including adherence to a personalised dietary regimen combined with regular physical activity in patients newly diagnosed with PCa under ADT.

Enrollment

30 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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