NCT06282185

Brief Summary

The goal of this single blind placebo-controlled intervention study is to examine the impact of a supervised training program on disease-related quality of life and physical fitness in patient with advanced prostate cancer compared to usual care. The main question\[s\] it aims to answer are:

  • What is the impact of exercise on quality of life
  • What is the impact of exercise on physical fitness Participants will have an individual training program with supervised training by physiotherapists. Researchers will compare with usual care to see if advice about exercise has significant less effect than an supervised training program.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

January 16, 2023

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2025

Completed
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

January 16, 2023

Last Update Submit

March 19, 2026

Conditions

Prostatic NeoplasmsMetastasis

Outcome Measures

Primary Outcomes (4)

  • change of quality of life assessed with EPIC26 (0-100 points)

    To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaire is used: Expanded Prostate Cancer Index Composite (EPIC26). With higher scores representing better disease-related quality of life.

    6 months

  • change of quality of life assessed with EPIC26 (0-100 points)

    To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaire is used: Expanded Prostate Cancer Index Composite (EPIC26). With higher scores representing better disease-related quality of life.

    3 months

  • change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale)

    To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaires are used: European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ-C30). A higher score represents a higher response level. So a higher score for the functional scale represents a higher level of physical functioning but a higher score for the symptoms scale represents a higher level of symptoms.

    6 months

  • change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale)

    To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaires are used: European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ-C30). A higher score represents a higher response level. So a higher score for the functional scale represents a higher level of physical functioning but a higher score for the symptoms scale represents a higher level of symptoms.

    3 months

Secondary Outcomes (6)

  • change of physical fitness in maximum uptake of oxygen in ml/kg/min

    6 months

  • change of physical fitness in maximum uptake of oxygen in ml/kg/min

    3 months

  • change of physical fitness in fat percentage

    3 months

  • change of physical fitness in fat percentage

    6 months

  • change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes))

    3 months

  • +1 more secondary outcomes

Study Arms (2)

intervention

EXPERIMENTAL

supervised training program for twelve weeks + usual care + advice about exercise

Other: Physiotherapy

usual care

NO INTERVENTION

usual care + advice about exercise

Interventions

PhysiotherapyOTHER

supervised training program for twelve weeks + usual care + advice about exercise

intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Age \> 18 years old
  • Able to read and complete questionnaires in Dutch
  • Proven histologically and /or radiologically metastatic prostate cancer (TxNxM1)

You may not qualify if:

  • Other cancers
  • Clinicians' judgement
  • Age \>80 years old or not able to walk 400m
  • Structural exercise (moderate-intensity exercise more than 150 minutes a week) during the past 3 months
  • Musculoskeletal, cardiovascular, or neurological disorders that could inhibit them from exercising
  • Spinal cord compression, history of pathological fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canisius Wilhelmina Ziekenhuis (CWZ)

Nijmegen, Gelderland, 6532SZ, Netherlands

Location

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasm Metastasis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Jean-Paul van Basten, Dr. MD

    Canisius Wilhelmina Ziekenhuis (CWZ)

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
In a single blinded (investigators blinded to group allocation) randomized controlled pilot, conducted in the CWZ, 20 patients with advanced prostate cancer will be randomized across: 1) supervised training program for twelve weeks + usual care + advice about exercise, or 2) usual care + advice about exercise.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial with an intervention arm and an usual care group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2023

First Posted

February 28, 2024

Study Start

November 1, 2024

Primary Completion

December 31, 2024

Study Completion

September 11, 2025

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)