Prostatic NeoplasmsSupermanNCT06282185
SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy
A study testing Physiotherapy in people with Prostatic Neoplasms and Metastasis, run by Canisius-Wilhelmina Hospital at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostatic Neoplasms, Metastasis
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2024to 11 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Age > 18 years old
- Able to read and complete questionnaires in Dutch
- Proven histologically and /or radiologically metastatic prostate cancer (TxNxM1)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Canisius Wilhelmina Ziekenhuis (CWZ)
Nijmegen, Gelderland, 6532SZ
About this study
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.
- Conditions
- Prostatic Neoplasms, Metastasis
- Being tested
- Physiotherapy
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
supervised training program for twelve weeks + usual care + advice about exercise
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | supervised training program for twelve weeks + usual care + advice about exercise Receives: Other: Physiotherapy |
| usual care | No intervention | usual care + advice about exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (6)
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.
Measured: 6 months
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.
Measured: 3 months
change of physical fitness in fat percentage
change in body composition in patients with metastatic prostate cancer compared to usual care.
Measured: 3 months
change of physical fitness in fat percentage
change in body composition in patients with metastatic prostate cancer compared to usual care.
Measured: 6 months
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.
Measured: 3 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Nov 2024
- Primary completion31 Dec 2024
- Study completion11 Sep 2025
Why it stopped: lagging inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial with an intervention arm and an usual care group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canisius-Wilhelmina Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul van Basten, Dr. MD, Principal investigator, Canisius-Wilhelmina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282185
- Sponsor's protocol ID
- CanisiusWH
- Acronym
- Superman
- Status last verified
- Mar 2026
- First submitted
- 16 Jan 2023
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy
- ClinicalTrials.gov ID
- NCT06282185
- Acronym / sponsor ID
- Superman / CanisiusWH
- Conditions
- Prostatic Neoplasms, Metastasis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lagging inclusions
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Canisius-Wilhelmina HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial with an intervention arm and an usual care group
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: Physiotherapysupervised training program for twelve weeks + usual care + advice about exercise |
| usual care | No intervention | –usual care + advice about exercise |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Age > 18 years old
- Able to read and complete questionnaires in Dutch
- Proven histologically and /or radiologically metastatic prostate cancer (TxNxM1)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapysupervised training program for twelve weeks + usual care + advice about exercise | Other | intervention |
Primary outcome
change of quality of life assessed with EPIC26 (0-100 points)
Time frame: 6 months
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.
change of quality of life assessed with EPIC26 (0-100 points)
Time frame: 3 months
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.
change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale)
Time frame: 6 months
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.
change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale)
Time frame: 3 months
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 secondary outcomes
change of physical fitness in maximum uptake of oxygen in ml/kg/min
Time frame: 6 months
change of physical fitness in maximum uptake of oxygen in ml/kg/min
Time frame: 3 months
change of physical fitness in fat percentage
Time frame: 3 months
change of physical fitness in fat percentage
Time frame: 6 months
change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes))
Time frame: 3 months
change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes))
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Prostatic Neoplasms
Active, not recruitingPhase 1
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Active, not recruitingPhase 3
An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
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Active, not recruitingPhase 1
A Study to Evaluate the Effect of Multiple Doses of JNJ-56021927 on the Pharmacokinetics of Multiple Cytochrome P450 and Transporter Substrates in Participants With Castration-Resistant Prostate Cancer
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Active, not recruitingPhase 2
18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer
Metastatic Prostate Cancer, Prostatic Neoplasms
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18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Paul van Basten, Dr. MD principal investigator
Canisius-Wilhelmina Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Prostatic Neoplasms and Metastasis, run by Canisius-Wilhelmina Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of quality of life assessed with EPIC26 (0-100 points) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026; AzTrials last refreshed its copy on 4 Nov 2026.