Health TrialsbyHealthPanel

Lifestyle Intervention in Patients With Metastatic Prostate Cancer

ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorOncology Institute of Southern Switzerland

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Lifestyle intervention

    Behavioral

    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).

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Arm treated with lifestyle interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Patient retention rate

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

Time frame
12 weeks
3

Adherence to prescribed training program

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

Time frame
12 weeks
4

Adherence to prescribed dietary regimen

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

Time frame
12 weeks

Secondary outcomes

1

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
2

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
3

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
4

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

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oncology Institute of Southern Switzerland

Lead sponsor

Source ClinicalTrials.gov
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