Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT05850182

Lifestyle Intervention in Patients With Metastatic Prostate Cancer

Led by Oncology Institute of Southern Switzerland · Updated on 2025-11-18

30

Participants Needed

1

Research Sites

161 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Lifestyle Intervention in Patients With Metastatic Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent according to ICH/GCP regulations before registration
  • Age 18 years or older
  • Histology of adenocarcinoma of the prostate
  • Patients receiving androgen deprivation therapy alone or combined with novel hormonal agents (abiraterone, enzalutamide, apalutamide, or darolutamide)
  • Rising PSA with two consecutively rising levels more than 25% above nadir at least three weeks apart
  • PSA doubling time greater than 8 weeks
  • Ongoing systemic treatment continuation feasible as deemed by treating physician
Not Eligible

You will not qualify if you...

  • Ongoing treatment with docetaxel, cabazitaxel, radionuclides, or investigational treatments
  • Evidence of clinical progression or progression on imaging
  • Bone metastases that exclude safety of physical exercise
  • Prior severe osteoporosis or bone diseases with fracture history
  • Clinically significant cardiovascular disease such as recent myocardial infarction, uncontrolled angina, severe heart failure, significant arrhythmias, or uncontrolled hypertension
  • Clinically significant chronic obstructive pulmonary disease
  • Any other disease or condition interfering with study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, Switzerland, 6500

Actively Recruiting

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Research Team

U

Ursula Vogl, MD

CONTACT

L

Luigi Tortola, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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