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NCT Number: NCT07162987

Prehabilitation to Patients With Prostate Cancer

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

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Key information

Conditions

Prostate Cancer (Diagnosis) Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Esbjerg Hospital, Esbjerg, Region Syddanmark, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • Persons who do not fulfil the inclusion criteria will be excluded

Treatment and study plan

Prehabilitation

Behavioral

Please refer to arm description

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    Measured by the Brief Fatigue Inventory (BFI), the aim is stable levels of fatigue from baseline to follow-up at 24 and 48 weeks.

  3. 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.

    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.

  4. 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

    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.

  5. 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 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.

  6. 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

    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.

  7. Change in function from baseline to follow-up measured by the 6MWT

    Time frame: Baseline and after finished exercise training at 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Esbjerg Hospital - University Hospital of Southern Denmark
  • Esbjerg Municipality
  • REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
  • Vejle Hospital

Registry information

Official study title

Prehabilitation to Patients With Prostate Cancer, Who Are About to Receive Androgen Deprivation Therapy and Radiation Therapy

Acronym: PREPP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 9, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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