Lifestyle Intervention in Patients With Metastatic Prostate Cancer

Oncology Institute of Southern Switzerland30 enrolled

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.

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Lifestyle interventionBEHAVIORAL

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).

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, Switzerland

RECRUITING

Outcomes

Primary Outcomes

Patient initiation rate

Study initiation rate (total number of patients enrolled divided by the number of patients screened for the study)

Time frame: 12 weeks

Patient retention rate

Retention rate (number of patients completing the study divided by total number of patients enrolled at baseline)

Time frame: 12 weeks

Adherence to prescribed training program

Adherence rate (fraction of scheduled physical activity appointments/selftrainings attended/carried out by the patients)

Time frame: 12 weeks

Adherence to prescribed dietary regimen

Adherence rate (fraction of days of adherence to the prescribed dietary regimen)

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 24 weeks

Effect of lifestyle intervention on PSA levels

PSA doubling time calculated with the formula PSA doubling time = ln (2) / PSA Slope \[PSA Slope = (ln (PSA level 2) - ln (PSA level 1)) / Time (no. of months)\]

Time frame: 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

Time frame: 24 weeks

Central Contacts

Ursula Vogl, MD

CONTACT

+41 91 811 84 63 ursula.vogl@eoc.ch

Luigi Tortola, PhD

CONTACT

+41 91 811 96 68 luigi.tortola@eoc.ch

Data from ClinicalTrials.gov

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