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

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Bellinzona, Switzerland, 6500
        • Oncology Institute of Southern Switzerland (IOSI)
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm treated with lifestyle intervention
Patients with prostate cancer will receive a lifestyle intervention on diet and physical activity.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient initiation rate
Time Frame: 12 weeks
Study initiation rate (total number of patients enrolled divided by the number of patients screened for the study)
12 weeks
Patient retention rate
Time Frame: 12 weeks
Retention rate (number of patients completing the study divided by total number of patients enrolled at baseline)
12 weeks
Adherence to prescribed training program
Time Frame: 12 weeks
Adherence rate (fraction of scheduled physical activity appointments/selftrainings attended/carried out by the patients)
12 weeks
Adherence to prescribed dietary regimen
Time Frame: 12 weeks
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
Time Frame: 24 weeks
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
Time Frame: 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)]
24 weeks
Effect of lifestyle intervention on radiographic progression
Time Frame: 24 weeks
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
Time Frame: 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
24 weeks
Effect of lifestyle intervention on patient-reported fatigue
Time Frame: 24 weeks
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 Frame: 24 months
Time to a subsequent line of treatment (in weeks)
24 months
Effect of lifestyle intervention on plasma lipid signature
Time Frame: 8 weeks
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
Time Frame: 8 weeks
Concentration of inflammatory cytokines in the plasma of participating patients, change compared to baseline
8 weeks
Effect of lifestyle intervention on microbiome composition
Time Frame: 8 weeks
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
Time Frame: 24 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
Measurement of the percentage of fat body mass by bioelectrical impedance vector analysis and by magnetic resonance imaging.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 31, 2023

Primary Completion (Anticipated)

May 31, 2025

Study Completion (Anticipated)

May 31, 2025

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

May 5, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ACTIDIET-PRO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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