Lifestyle Intervention in Patients With Metastatic Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Lifestyle intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm treated with lifestyle intervention<br>Patients with prostate cancer will receive a lifestyle intervention on diet and physical activity. | Behavioral: Lifestyle intervention<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient initiation rate | Study initiation rate (total number of patients enrolled divided by the number of patients screened for the study) | 12 weeks | 
| Patient retention rate | Retention rate (number of patients completing the study divided by total number of patients enrolled at baseline) | 12 weeks | 
| Adherence to prescribed training program | Adherence rate (fraction of scheduled physical activity appointments/selftrainings attended/carried out by the patients) | 12 weeks | 
| Adherence to prescribed dietary regimen | Adherence rate (fraction of days of adherence to the prescribed dietary regimen) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of lifestyle intervention on PSA progression | Percentage of PSA non-progressors (patients with <25% PSA rise compared to baseline) at weeks 8, 12 and 24 | 24 weeks | 
| Effect of lifestyle intervention on PSA levels | 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)] | 24 weeks | 
| Effect of lifestyle intervention on radiographic progression | Percentage of patients being free of radiographic progression according to PCWG3 at weeks 12 and 24 | 24 weeks | 
| Effect of lifestyle intervention on patient-reported quality of life | 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 | 24 weeks | 
| Effect of lifestyle intervention on patient-reported fatigue | Change in patient-reported fatigue from baseline using FACIT Fatigue scoring from baseline to weeks 8, 12 and 24 | 24 weeks | 
| Effect of lifestyle intervention on time to subsequent treatment | Time to a subsequent line of treatment (in weeks) | 24 months | 
| Effect of lifestyle intervention on plasma lipid signature | Concentration of individual lipid types in the plasma of participating patients, change compared to baseline | 8 weeks | 
| Effect of lifestyle intervention on plasma immune signature | Concentration of inflammatory cytokines in the plasma of participating patients, change compared to baseline | 8 weeks | 
| Effect of lifestyle intervention on microbiome composition | Differences in community diversity and/or abundance of specific bacterial taxa within the intestinal microbiome prior to or during the lifestyle intervention. | 8 weeks | 
| Effect of lifestyle intervention on anthropometric variables | Measurement of patient height and body weight and calculation of body-mass index (BMI) at baseline, during and after the lifesyle intervention. | 24 weeks | 
| Effect of lifestyle intervention on lean body mass | Measurement of the percentage of lean body mass by bioelectrical impedance vector analysis and by magnetic resonance imaging. | 12 weeks | 
| Effect of lifestyle intervention on fat body mass | Measurement of the percentage of fat body mass by bioelectrical impedance vector analysis and by magnetic resonance imaging. | 12 weeks |