Lifestyle Intervention in Patients With Metastatic Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Behavioral: Lifestyle intervention
- Registration Number
- NCT05850182
- Lead Sponsor
- Oncology Institute of Southern Switzerland
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm treated with lifestyle intervention Lifestyle intervention Patients with prostate cancer will receive a lifestyle intervention on diet and physical activity.
- Primary Outcome Measures
Name Time Method Patient initiation rate 12 weeks Study initiation rate (total number of patients enrolled divided by the number of patients screened for the study)
Adherence to prescribed training program 12 weeks Adherence rate (fraction of scheduled physical activity appointments/selftrainings attended/carried out by the patients)
Patient retention rate 12 weeks Retention rate (number of patients completing the study divided by total number of patients enrolled at baseline)
Adherence to prescribed dietary regimen 12 weeks Adherence rate (fraction of days of adherence to the prescribed dietary regimen)
- Secondary Outcome Measures
Name Time Method Effect of lifestyle intervention on PSA progression 24 weeks Percentage of PSA non-progressors (patients with \<25% PSA rise compared to baseline) at weeks 8, 12 and 24
Effect of lifestyle intervention on PSA levels 24 weeks PSA doubling time calculated with the formula PSA doubling time = ln (2) / PSA Slope \[PSA Slope = (ln (PSA level 2) - ln (PSA level 1)) / Time (no. of months)\]
Effect of lifestyle intervention on time to subsequent treatment 24 months Time to a subsequent line of treatment (in weeks)
Effect of lifestyle intervention on plasma immune signature 8 weeks Concentration of inflammatory cytokines in the plasma of participating patients, change compared to baseline
Effect of lifestyle intervention on radiographic progression 24 weeks Percentage of patients being free of radiographic progression according to PCWG3 at weeks 12 and 24
Effect of lifestyle intervention on patient-reported quality of life 24 weeks Change in patient-reported quality of life from baseline using Functional Assessment of Cancer Therapy - Prostate (FACT-P) scoring from baseline to weeks 8, 12 and 24
Effect of lifestyle intervention on patient-reported fatigue 24 weeks Change in patient-reported fatigue from baseline using FACIT Fatigue scoring from baseline to weeks 8, 12 and 24
Effect of lifestyle intervention on plasma lipid signature 8 weeks Concentration of individual lipid types in the plasma of participating patients, change compared to baseline
Effect of lifestyle intervention on microbiome composition 8 weeks Differences in community diversity and/or abundance of specific bacterial taxa within the intestinal microbiome prior to or during the lifestyle intervention.
Effect of lifestyle intervention on anthropometric variables 24 weeks Measurement of patient height and body weight and calculation of body-mass index (BMI) at baseline, during and after the lifesyle intervention.
Effect of lifestyle intervention on lean body mass 12 weeks Measurement of the percentage of lean body mass by bioelectrical impedance vector analysis and by magnetic resonance imaging.
Effect of lifestyle intervention on fat body mass 12 weeks Measurement of the percentage of fat body mass by bioelectrical impedance vector analysis and by magnetic resonance imaging.
Trial Locations
- Locations (1)
Oncology Institute of Southern Switzerland (IOSI)
🇨🇭Bellinzona, Switzerland