Lifestyle Intervention in Patients With Metastatic Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lifestyle intervention.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed 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.
Interventions
- Behavioral Lifestyle intervention
12-week lifestyle intervention including adherence to a personalized balanced dietary regimen (low total fat, low saturated fat, high ω3 fatty acids, optimized protein content, low simple sugars) combined with regular physical activity (including physiotherapy sessions and self-training).
Primary outcome measures
- Patient initiation rate [Time frame: 12 weeks]
- Patient retention rate [Time frame: 12 weeks]
- Adherence to prescribed training program [Time frame: 12 weeks]
- Adherence to prescribed dietary regimen [Time frame: 12 weeks]
Secondary outcome measures (12)
- Effect of lifestyle intervention on PSA progression [Time frame: 24 weeks]
- Effect of lifestyle intervention on PSA levels [Time frame: 24 weeks]
- Effect of lifestyle intervention on radiographic progression [Time frame: 24 weeks]
- Effect of lifestyle intervention on patient-reported quality of life [Time frame: 24 weeks]
- Effect of lifestyle intervention on patient-reported fatigue [Time frame: 24 weeks]
- Effect of lifestyle intervention on time to subsequent treatment [Time frame: 24 months]
- Effect of lifestyle intervention on plasma lipid signature [Time frame: 8 weeks]
- Effect of lifestyle intervention on plasma immune signature [Time frame: 8 weeks]
- Effect of lifestyle intervention on microbiome composition [Time frame: 8 weeks]
- Effect of lifestyle intervention on anthropometric variables [Time frame: 24 weeks]
- Effect of lifestyle intervention on lean body mass [Time frame: 12 weeks]
- Effect of lifestyle intervention on fat body mass [Time frame: 12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Switzerland · 1 center
- Oncology Institute of Southern Switzerland (IOSI) — Bellinzona
Identifiers
NCT: NCT05850182 · ACTIDIET-PRO