ClinicalTrials.gg
WithdrawnNCT06282185SupermanUpdated Mar 23, 2026

SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy

An interventional study of Physiotherapy in Prostatic Neoplasms and Metastasis, sponsored by Canisius-Wilhelmina Hospital. Withdrawn at 1 site in Netherlands. Open to male participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-03-23.

Sponsored by Canisius-Wilhelmina Hospital · Not applicable, Interventional, and Treatment

Why this study was withdrawn
lagging inclusions
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostatic Neoplasms
  • Metastasis
03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

Browse Prostatic Neoplasms studies →

Lead sponsor

Canisius-Wilhelmina Hospital is the lead sponsor of 11 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    intervention

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

    Other: Physiotherapy

  • No intervention
    usual care

    usual care + advice about exercise

Interventions

  • OtherPhysiotherapy

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 3 months

  3. 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.

    Time frame: 6 months

  4. 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.

    Time frame: 3 months

Secondary outcomes

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

    Assessment of the effectiveness of a supervised training program on cardiopulmonary fitness in patients with metastatic prostate cancer compared to usual care.

    Time frame: 6 months

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

    Assessment of the effectiveness of a supervised training program on cardiopulmonary fitness and body composition in patients with metastatic prostate cancer compared to usual care.

    Time frame: 3 months

  3. change of physical fitness in fat percentage

    change in body composition in patients with metastatic prostate cancer compared to usual care.

    Time frame: 3 months

  4. change of physical fitness in fat percentage

    change in body composition in patients with metastatic prostate cancer compared to usual care.

    Time frame: 6 months

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

    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: Short Hebrew International Physical Activity Questionnaire (IPAQ-sh). Both categorical and continuous indicators of physical activity will be used from the IPAQ short form. There are three categories:1. inactive, 2. minimally active, 3. HEPA active (health enhancing physical activity; a high active category). The continuous score is reported in median MET-minutes (metabolic equivalent of task-minutes). For categorical and continuous score is a higher score equivalent of higher physical functioning.

    Time frame: 3 months

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

    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: Short Hebrew International Physical Activity Questionnaire (IPAQ-sh). Both categorical and continuous indicators of physical activity will be used from the IPAQ short form. There are three categories:1. inactive, 2. minimally active, 3. HEPA active (health enhancing physical activity; a high active category). The continuous score is reported in median MET-minutes (metabolic equivalent of task-minutes). For categorical and continuous score is a higher score equivalent of higher physical functioning.

    Time frame: 6 months

07

Study locations

1 site
  • Canisius Wilhelmina Ziekenhuis (CWZ)
    Nijmegen, Gelderland 6532SZ, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2024 to primary completion in Dec 2024, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 16, 2023
First posted
Feb 28, 2024
StartActual
Nov 1, 2024
Primary completionActual
Dec 31, 2024
CompletionActual
Sep 11, 2025
Last update
Mar 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06282185
Lead sponsor
Canisius-Wilhelmina Hospital
Responsible party
Sponsor
First posted
Feb 28, 2024
Start date
Nov 1, 2024
Primary completion
Dec 31, 2024
Completion
Sep 11, 2025
Last update
Mar 23, 2026

Study contacts

Jean-Paul van Basten, Dr. MD
principal investigator · Canisius-Wilhelmina Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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