Prostate Cancer (Diagnosis)PREPPNCT07162987
Prehabilitation to Patients With Prostate Cancer
A study testing Prehabilitation in people with Prostate Cancer (Diagnosis), run by Odense University Hospital at 3 sites in Denmark.
Trial summary
The goal of this feasibility study is to test a newly developed, multicomponent prehabilitation intervention to patients with prostate cancer, to improve their resilience to treatment side-effects. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Diagnosis)
- What is being tested?
- Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesDenmark
- Study dates
- 4 Aug 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with prostate cancer
- min 18 years old
- Treatment: Androgen deprivation therapy and raditation therapy
- Resident in Vejle Municipality or Esbjerg Municipality
- Can take part in residential prehabiliation in week 43 or 50, 2025, as well as physical exsercise training in the municipality
- Willing to take part in a research study
Show all 9Show fewer
- Suited to take part in group sessions
- Be able to read and be understood in Danish
- Be responsible for own personal hygiene and medications at the 4-day residential stay
Who cannot join
- Persons who do not fulfil the inclusion criteria will be excluded
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Esbjerg Hospital
Esbjerg, Region Syddanmark, 6700
Cecilie L Egholm, PhD, 4529212232, cecilie.lindstrom.egholm@rsyd.dk
- Recruiting
REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care
Nyborg, Region Syddanmark, 5800
Cecilie L Egholm, PhD, 4529212232, cecilie.lindstrom.egholm@rsyd.dk
- Recruiting
Vejle Hospital
Vejle, Region Syddanmark, 7100
Cecilie L Egholm, PhD, 45 29 21 22 32, cecilie.lindstrom.egholm@rsyd.dk
About this study
Official title: Prehabilitation to Patients With Prostate Cancer, Who Are About to Receive Androgen Deprivation Therapy and Radiation Therapy
The goal of this feasibility study is to test a newly developed, multicomponent prehabilitation intervention to patients with prostate cancer, to improve their resilience to treatment side-effects. The main questions it aims to answer are:
- Are patients and their close relatives willing to take part in prehabilitation?
- What is the acceptability and feasibility of the prehabilitation intervention, seen from the perspectives of patients, their close relatives, and healthcare professionals?
- Are the planned data collection methods feasible, and are there indications of a clinical effect?
Read more
Participants will:
- Take part in 12 weeks of physical exercise training
- Attend a 4-day residential prehabilitation intervention, where they receive education and do exercises. After 12 weeks, it is possible to take part in a voluntary follow-up session.
- Patients will respond to questionnaires about their health, symptoms, and quality of life. Patients and their close relatives will attend a group interview. Patients will also complete an exercise diary and brief physical tests
- Conditions
- Prostate Cancer (Diagnosis)
- Being tested
- Prehabilitation
- Keywords
- prostate cancer, prehabilitation, androgen deprivation therapy, radiation therapy
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationBehavioural
Please refer to arm description
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving prehabilitation | Experimental | The prehabilitation intervention includes: - Education about the disease and treatment - Physical exsercise training - Values in life - Energy preservation - Nutrition with a focus on hormone therapy - Identiy and role changes - Intimacy and sexuality - Sleep - Pelvic floor training - An individual session with a healthcare professional incl. goal setting Receives: Behavioral: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to follow-up in quality of life measured by EORTC-QLQ-C30
This is a pilot study with one arm only, thus the aim is mainly to test the feasibility of the chosen primary outcome measure, including whether there are tendencies in data that support the aim of participants maintaining stable quality of life. Hence, measured by the European Organization for the Research and Treatment of Cancer Qality of life Questionnaire (EORTC QLQ-C30), the target is unchanged (stable) quality of life measured from baseline to follow-up at 24 and 48 weeks.
Measured: From baseline (shortly after enrollment) to 24 and 48 weeks later.
Secondary outcomes (7)
Change in prostate-cancer related symptoms and problems from baseline to follow-up measured by the EPIC-26
As with the primary outcome measure, the purpose in this pilot study is mainly to test the feasibility of the chosen secondary outcome measures. One of the secondary outcomes is prostate cancer related quality of life, measured by five domains in the Expanded Prostate Cancer Index Composite (EPIC-26): urinary incontinence (four items), urinary irritation/obstruction (four items), bowel (six items), sexual (six items) and vitality/hormonal function (five items) and a single-item measure of overall urinary bother. The aim is for the scores in these domains to remain stable from baseline to follow-up at 24 and 48 weeks.
Measured: Measured at baseline (shortly after recruitment) and at 24 and 48 weeks.
Change in fatigue from baseline to follow-up using the BFI
Measured by the Brief Fatigue Inventory (BFI), the aim is stable levels of fatigue from baseline to follow-up at 24 and 48 weeks.
Measured: Measured at baseline (shortly after inclusion) and at 24 and 48 weeks.
Change in anxiety from baseline to follow up measured by the GAD-7
As with all other measures tested in this one-armed pilot study, the main aim is to test the feasibility of the chosen outcome measures.
We aim to measure change in anxiety from baseline to follow-up at 24 and 48 weeks measured by the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire. The target is unchanged anxiety.
Measured: At baseline (shortly after inclusion) and at 24 and 48 weeks.
Change in depression from baseline to follow-up measured by the PHQ-9
We aim to measure depression severity using the Patient Health Questionnaire-9 (PHQ-9). The target is unchanged depression score from baseline to follow-up.
Measured: Measured at baseline (shortly after inclusion) and at 24 and 48 weeks
Change in BMI from baseline to follow-up calculated from self-reported height and weight
Change in body mass index (BMI) can be calculated after retrieving the patients' weight and height. Height in meters will be collected at baseline by self-report (through a patient questionnaire). Weight in kilograms will be collected at baseline and follow-up also by self-report. Weight and height will hereafter be combined to report BMI in kg/m^2. The target is no change in BMI from baseline to follow-up.
Measured: Baseline and at 24 and 48 weeks.
Change in muscle strength from baseline to follow-up measured by 30 sec sit-to-stand test
Lower limb muscle strength is measured by the 30 seconds sit-to-stand test. The target is unchanged muscle strength from baseline to follow-up.
Measured: Baseline and after finished exercise training at 12 weeks
Change in function from baseline to follow-up measured by the 6MWT
Functional exercise capacity is measured by the 6-minute walk test (6MWT). The target is no change in functional exercise capacity from baseline to follow-up.
Measured: Baseline and after finished exercise training at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start4 Aug 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care, Vejle Hospital, Esbjerg Municipality, Esbjerg Hospital - University Hospital of Southern Denmark
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162987
- Sponsor's protocol ID
- 25/31257
- Acronym
- PREPP
- Status last verified
- Sep 2025
- First submitted
- 30 Jul 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A de-identified copy of data may be made available to external researchers upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation to Patients With Prostate Cancer, Who Are About to Receive Androgen Deprivation Therapy and Radiation Therapy
- ClinicalTrials.gov ID
- NCT07162987
- Acronym / sponsor ID
- PREPP / 25/31257
- Conditions
- Prostate Cancer (Diagnosis)
- Keywords
- prostate cancer, prehabilitation, androgen deprivation therapy, radiation therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care, Vejle Hospital, Esbjerg Municipality, Esbjerg Hospital - University Hospital of Southern Denmark
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 9 Sep 2025 (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 feasibility study is to test a newly developed, multicomponent prehabilitation intervention to patients with prostate cancer, to improve their resilience to treatment side-effects. The main questions it aims to answer are:
- Are patients and their close relatives willing to take part in prehabilitation?
- What is the acceptability and feasibility of the prehabilitation intervention, seen from the perspectives of patients, their close relatives, and healthcare professionals?
- Are the planned data collection methods feasible, and are there indications of a clinical effect?
Participants will:
- Take part in 12 weeks of physical exercise training
- Attend a 4-day residential prehabilitation intervention, where they receive education and do exercises. After 12 weeks, it is possible to take part in a voluntary follow-up session.
- Patients will respond to questionnaires about their health, symptoms, and quality of life. Patients and their close relatives will attend a group interview. Patients will also complete an exercise diary and brief physical tests
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving prehabilitation | Experimental | Behavioral: PrehabilitationThe prehabilitation intervention includes: - Education about the disease and treatment - Physical exsercise training - Values in life - Energy preservation - Nutrition with a focus on hormone therapy - Identiy and role changes - Intimacy and sexuality - Sleep - Pelvic floor training - An individual session with a healthcare professional incl. goal setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosed with prostate cancer
- min 18 years old
- Treatment: Androgen deprivation therapy and raditation therapy
- Resident in Vejle Municipality or Esbjerg Municipality
- Can take part in residential prehabiliation in week 43 or 50, 2025, as well as physical exsercise training in the municipality
Key exclusion criteria (1 listed)
- Persons who do not fulfil the inclusion criteria will be excluded
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 |
|---|---|---|
| PrehabilitationPlease refer to arm description | Behavioural | Patients receiving prehabilitation |
Primary outcome
Change from baseline to follow-up in quality of life measured by EORTC-QLQ-C30
Time frame: From baseline (shortly after enrollment) to 24 and 48 weeks later.
This is a pilot study with one arm only, thus the aim is mainly to test the feasibility of the chosen primary outcome measure, including whether there are tendencies in data that support the aim of participants maintaining stable quality of life. Hence, measured by the European Organization for the Research and Treatment of Cancer Qality of life Questionnaire (EORTC QLQ-C30), the target is unchanged (stable) quality of life measured from baseline to follow-up at 24 and 48 weeks.
7 secondary outcomes
Change in prostate-cancer related symptoms and problems from baseline to follow-up measured by the EPIC-26
Time frame: Measured at baseline (shortly after recruitment) and at 24 and 48 weeks.
Change in fatigue from baseline to follow-up using the BFI
Time frame: Measured at baseline (shortly after inclusion) and at 24 and 48 weeks.
Change in anxiety from baseline to follow up measured by the GAD-7
Time frame: At baseline (shortly after inclusion) and at 24 and 48 weeks.
Change in depression from baseline to follow-up measured by the PHQ-9
Time frame: Measured at baseline (shortly after inclusion) and at 24 and 48 weeks
Change in BMI from baseline to follow-up calculated from self-reported height and weight
Time frame: Baseline and at 24 and 48 weeks.
Change in muscle strength from baseline to follow-up measured by 30 sec sit-to-stand test
Time frame: Baseline and after finished exercise training at 12 weeks
Change in function from baseline to follow-up measured by the 6MWT
Time frame: Baseline and after finished exercise training at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: Undecided. A de-identified copy of data may be made available to external researchers upon reasonable request.
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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.
REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care
Nyborg, Denmark
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Prostate Cancer (Diagnosis), run by Odense University Hospital at 3 sites in Denmark.
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 9 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to follow-up in quality of life measured by EORTC-QLQ-C30 (time frame: From baseline (shortly after enrollment) to 24 and 48 weeks later.). 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 9 Sep 2025.