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NCT Number: NCT06449664

Training for Men Undergoing Androgen Deprivation Therapy.

The goal of this clinical trial is to evaluate the effects of a newly developed training concept on men with prostate cancer undergoing androgen deprivation therapy (ADT).

The main questions it aims to answer are:

* How feasible and safe is the new training concept? * How efficient is the training concept to counteract side effects caused by ADT?

Researchers will compare the new training concept with usual care to evaluate how efficient the training concept is to counteract the ADT-related side effects.

Participants in the intervention group will perform the new training concept twice weekly for 12 weeks. Participants in the control group will only receive usual care. All participants will visit the laboratory at baseline and after 6 and 12 weeks to measure the primary and secondary outcomes.

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Key information

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Swedish School of Sport and Health Sciences

Stockholm, 11486, Sweden

Location status: Recruiting

Location contact

Niklas Psilander, PhD

CONTACT

[email protected]

+46 8 120 538 23

Niklas Psilander, PhD

PRINCIPAL_INVESTIGATOR

About this study

Detailed description of the training concept applied in the intervention:

The two weekly training sessions will be separated by at least two days and supervised by appropriately trained exercise professionals at The Swedish School of Sport and Health Sciences. The training includes a 10 min warm-up followed by 3-4 sets of 8 maximal repetitions on the flywheel machine followed by 16-24, 20 s intervals on a Monark cycle ergometer. The intervals will be performed as 3 blocks with the intention to execute 8 intervals in each block. When a participant manages to perform all 3 blocks with 8 intervals in each block (a total of 24 intervals) the resistance will be increased by ~20 W. The rest period between the intervals will be set to 10 s and the rest between the blocks to 2 min. The starting workload of the intervals will be individually adjusted to ~115 % of the participant's power output at VO2peak. The total duration of a training session will be 30-40 min (including worm-up).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • signed informed consent
  • histologically confirmed localised or locally advanced prostate cancer
  • planned radiotherapy in combination with ADT for at least six months (unfavorable intermediate risk and high-risk prostate cancer) with curative intent and with no known metastasis.

Exclusion criteria

  • very high risk localised prostate cancer planned for radiotherapy and ADT plus abiraterone and cortisone
  • localized prostate cancer planned for radiotherapy without ADT
  • on-going or previously treated with ADT or other hormonal treatments
  • have any contraindications to physical testing/exercise as per the ACSM guidelines
  • unable to comply with study procedures

Treatment and study plan

ADT-train

Behavioral

A new training concept is tested on men with prostate cancer receiving androgen deprivation therapy

Primary outcomes

  1. Aerobic fitness

    Time frame: Baseline and after 6 and 12 weeks

    VO2peak (ml/kg/min); incremental ramp test on a cycle ergometer

  2. Maximal leg strength

    Time frame: Baseline and after 6 and 12 weeks

    Isometric squat test (N) measured on force plates

Secondary outcomes

  1. Body fat

    Time frame: Baseline and after 6 and 12 weeks

    Assessed by dual-energy x-ray absorptiometry (DEXA) (kg)

  2. Lean body mass

    Time frame: Baseline and after 6 and 12 weeks

    Assessed by dual-energy x-ray absorptiometry (DEXA) (kg)

  3. Bone mineral density

    Time frame: Baseline and after 6 and 12 weeks

    Assessed by dual-energy x-ray absorptiometry (DEXA) (g/cm2)

  4. Quadriceps cross-sectional area

    Time frame: Baseline and after 6 and 12 weeks

    Assessed by ultrasound (mm)

  5. Static balance

    Time frame: Baseline and after 6 and 12 weeks

    One leg balance test on the right and the left foot. Time to first footing is measured and the number of footings during 60s.

  6. Walk capacity

    Time frame: Baseline and after 6 and 12 weeks

    Usual and fast pace 6m walk test (s)

  7. Lower body muscular endurance

    Time frame: Baseline and after 6 and 12 weeks

    30 s chair stand test. Maximal number of sit-to-stand repetitions during 30 s.

  8. Blood pressure

    Time frame: Baseline and after 6 and 12 weeks

    Assessed by an automated blood pressure monitor (mmHg).

  9. Whole body glucose uptake

    Time frame: Baseline and after 6 and 12 weeks

    Assessed by an oral glucose tolerance test in which the participants will ingest a standardized glucose drink and blood glucose levels will be monitored throughout a period of 2 hours (mmol/L).

  10. Whole body insulin response

    Time frame: Baseline and after 6 and 12 weeks

    Assessed by an oral glucose tolerance test in which the participants will ingest a standardized glucose drink and blood insulin levels will be monitored throughout a period of 2 hours (μU/mL).

  11. Blood biomarkers related to cardiovascular disease.

    Time frame: Baseline and after 6 and 12 weeks

    Assessed by high-multiplex immunoassays quantifying proteins associated with biological functions linked to cardiovascular diseases. Approximately 100 proteins will be assessed. Examples of proteins are: C-Reactive Protein (CRP), Tissue Factor (F3), and Thrombomodulin (THBD).

  12. Muscle fiber cross-sectional area (CSA)

    Time frame: Baseline and after 12 weeks

    Type I and type II muscle CSA will be assessed by immunohistochemistry (µm2).

  13. Muscle fiber distribution

    Time frame: Baseline and after 12 weeks

    Type I and type II muscle fiber distribution will be assessed by immunohistochemistry (%).

  14. Capillary content

    Time frame: Baseline and after 12 weeks

    The number of capillaries per muscle fiber will be assessed by immunohistochemistry.

  15. Myonuclei content

    Time frame: Baseline and after 12 weeks

    The number of myonuclei per muscle fiber CSA will be assessed by immunohistochemistry.

  16. Satellite cell content

    Time frame: Baseline and after 12 weeks

    The number of satellite cells per muscle fiber CSA will be assessed by immunohistochemistry.

  17. Mitochondrial content

    Time frame: Baseline and after 12 weeks

    Mitochondrial content will be assessed by measuring citrate synthase activity in homogenized muscle samples (mmol/kg/dw/min).

  18. Mitochondrial respiration

    Time frame: Baseline and after 12 weeks

    Mitochondrial respiration will be assessed by respirometry of permeabilized muscle fibers (respiration ratio).

  19. Genome-wide DNA methylation

    Time frame: Baseline and after 12 weeks

    Assessed by Illumina EPIC arrays to identify epigenetically regulated genes and pathways associated with exercise and the ADT-treatment.

  20. Transcriptome-wide RNA expression

    Time frame: Baseline and after 12 weeks

    Assessed by RNA-sequencing to identify differently regulated genes and pathways associated with exercise and the ADT-treatment.

  21. Protein expression

    Time frame: Baseline and after 12 weeks

    Assessed by Western Blot and ELISA (AU). This could for example be proteins related to genes identified by the genome-wide DNA methylation analysis or transcriptome-wide RNA expression analysis.

  22. Gene expression

    Time frame: Baseline and after 12 weeks

    Assessed by quantitative real-time PCR (AU). This could for example be genes identified by the genome-wide DNA methylation analysis or transcriptome-wide RNA expression analysis.

  23. Cancer treatment-related symptoms

    Time frame: Baseline and after 6 and 12 weeks

    Assessed by the National Prostate Cancer Register (NPCR) form. Scores scaled from 0 to 7. A higher score indicates more severe symptoms.

  24. Physical activity

    Time frame: Baseline and after 6 and 12 weeks

    Assessed by the physical activity questionnaire. Scores scaled from 1 to 8. A higher score indicates a more physically active participant.

  25. Physical and psychological health

    Time frame: Baseline and after 6 and 12 weeks

    Assessed by the Short Form Health Survey (SF-36). Scores scaled from 1 to 6. A higher score indicates better physical and psychological health.

  26. Anxiety and depression

    Time frame: Baseline and after 6 and 12 weeks

    Assessed by the Hospital Anxiety and Depression Scale (HADS). Scores scaled from 0 to 3. A higher score indicates more anxiety and depression.

  27. Cancer and treatment-related fatigue

    Time frame: Baseline and after 6 and 12 weeks

    Assessed by the Multidimensional Fatigue Inventory survey (MFI-20). Scores scaled from 1 to 5. A higher score indicates more fatigue.

Study contacts

Contact information is provided by the study sponsor or research team.

Niklas Psilander, PhD

CONTACT

[email protected]

+46 8 120 538 23

Sponsors and collaborators

Lead sponsor

The Swedish School of Sport and Health Sciences

Other

Collaborators

  • Karolinska Institutet
  • Norwegian School of Sport Sciences
  • Prostate Cancer Foundation
  • Sahlgrenska University Hospital

Registry information

Official study title

ADT-Train - A New Training Concept for Men With Prostate Cancer Receiving Androgen Deprivation Therapy.

Acronym: ADT-train

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jun 10, 2024
Registry last updated
Jun 10, 2024

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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