NCT05850182

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
8mo left

Started Nov 2023

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Nov 2023Dec 2026

First Submitted

Initial submission to the registry

April 24, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

November 27, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

3.1 years

First QC Date

April 24, 2023

Last Update Submit

November 14, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (12)

  • Effect of lifestyle intervention on PSA progression

    24 weeks

  • Effect of lifestyle intervention on PSA levels

    24 weeks

  • Effect of lifestyle intervention on radiographic progression

    24 weeks

  • Effect of lifestyle intervention on patient-reported quality of life

    24 weeks

  • Effect of lifestyle intervention on patient-reported fatigue

    24 weeks

  • +7 more secondary outcomes

Study Arms (1)

Arm treated with lifestyle intervention

EXPERIMENTAL

Patients with prostate cancer will receive a lifestyle intervention on diet and physical activity.

Behavioral: Lifestyle intervention

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).

Arm treated with lifestyle intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, 6500, Switzerland

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Ursula Vogl, MD

CONTACT

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

Luigi Tortola, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2023

First Posted

May 9, 2023

Study Start

November 27, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations

CH(1)