Prostate CancerADT-trainNCT06449664
Training for Men Undergoing Androgen Deprivation Therapy.
A study testing ADT-train in people with Prostate Cancer, run by The Swedish School of Sport and Health Sciences at 1 site in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ADT-train
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2024to 20 Dec 2028
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Swedish School of Sport and Health Sciences
Stockholm, 11486
Niklas Psilander, PhD, +46 8 120 538 23, niklas.psilander@gih.se
Niklas Psilander, PhD
About this study
Official title: ADT-Train - A New Training Concept for Men With Prostate Cancer Receiving 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:
Read more
- 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.
Read the detailed description
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).
- Conditions
- Prostate Cancer
- Being tested
- ADT-train
- Keywords
- Androgen deprivation therapy (ADT), Flywheel training, High intensity training (HIT), Resistance training, Aerobic training
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADT-trainBehavioural
A new training concept is tested on men with prostate cancer receiving androgen deprivation therapy
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | The participants will exercise twice weekly performing the newly developed training concept including flywheel resistance training followed by aerobic cycling intervals. Receives: Behavioral: ADT-train |
| Control group | No intervention | The participants will receive usual care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic fitness
VO2peak (ml/kg/min); incremental ramp test on a cycle ergometer
Measured: Baseline and after 6 and 12 weeks
Maximal leg strength
Isometric squat test (N) measured on force plates
Measured: Baseline and after 6 and 12 weeks
Secondary outcomes (27)
Body fat
Assessed by dual-energy x-ray absorptiometry (DEXA) (kg)
Measured: Baseline and after 6 and 12 weeks
Lean body mass
Assessed by dual-energy x-ray absorptiometry (DEXA) (kg)
Measured: Baseline and after 6 and 12 weeks
Bone mineral density
Assessed by dual-energy x-ray absorptiometry (DEXA) (g/cm2)
Measured: Baseline and after 6 and 12 weeks
Quadriceps cross-sectional area
Assessed by ultrasound (mm)
Measured: Baseline and after 6 and 12 weeks
Static balance
One leg balance test on the right and the left foot. Time to first footing is measured and the number of footings during 60s.
Measured: Baseline and after 6 and 12 weeks
Walk capacity
Usual and fast pace 6m walk test (s)
Measured: Baseline and after 6 and 12 weeks
Lower body muscular endurance
30 s chair stand test. Maximal number of sit-to-stand repetitions during 30 s.
Measured: Baseline and after 6 and 12 weeks
Blood pressure
Assessed by an automated blood pressure monitor (mmHg).
Measured: Baseline and after 6 and 12 weeks
Whole body glucose uptake
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).
Measured: Baseline and after 6 and 12 weeks
Whole body insulin response
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).
Measured: Baseline and after 6 and 12 weeks
Blood biomarkers related to cardiovascular disease.
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).
Measured: Baseline and after 6 and 12 weeks
Muscle fiber cross-sectional area (CSA)
Type I and type II muscle CSA will be assessed by immunohistochemistry (µm2).
Measured: Baseline and after 12 weeks
Muscle fiber distribution
Type I and type II muscle fiber distribution will be assessed by immunohistochemistry (%).
Measured: Baseline and after 12 weeks
Capillary content
The number of capillaries per muscle fiber will be assessed by immunohistochemistry.
Measured: Baseline and after 12 weeks
Myonuclei content
The number of myonuclei per muscle fiber CSA will be assessed by immunohistochemistry.
Measured: Baseline and after 12 weeks
Satellite cell content
The number of satellite cells per muscle fiber CSA will be assessed by immunohistochemistry.
Measured: Baseline and after 12 weeks
Mitochondrial content
Mitochondrial content will be assessed by measuring citrate synthase activity in homogenized muscle samples (mmol/kg/dw/min).
Measured: Baseline and after 12 weeks
Mitochondrial respiration
Mitochondrial respiration will be assessed by respirometry of permeabilized muscle fibers (respiration ratio).
Measured: Baseline and after 12 weeks
Genome-wide DNA methylation
Assessed by Illumina EPIC arrays to identify epigenetically regulated genes and pathways associated with exercise and the ADT-treatment.
Measured: Baseline and after 12 weeks
Transcriptome-wide RNA expression
Assessed by RNA-sequencing to identify differently regulated genes and pathways associated with exercise and the ADT-treatment.
Measured: Baseline and after 12 weeks
Protein expression
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.
Measured: Baseline and after 12 weeks
Gene expression
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.
Measured: Baseline and after 12 weeks
Cancer treatment-related symptoms
Assessed by the National Prostate Cancer Register (NPCR) form. Scores scaled from 0 to 7. A higher score indicates more severe symptoms.
Measured: Baseline and after 6 and 12 weeks
Physical activity
Assessed by the physical activity questionnaire. Scores scaled from 1 to 8. A higher score indicates a more physically active participant.
Measured: Baseline and after 6 and 12 weeks
Physical and psychological health
Assessed by the Short Form Health Survey (SF-36). Scores scaled from 1 to 6. A higher score indicates better physical and psychological health.
Measured: Baseline and after 6 and 12 weeks
Anxiety and depression
Assessed by the Hospital Anxiety and Depression Scale (HADS). Scores scaled from 0 to 3. A higher score indicates more anxiety and depression.
Measured: Baseline and after 6 and 12 weeks
Cancer and treatment-related fatigue
Assessed by the Multidimensional Fatigue Inventory survey (MFI-20). Scores scaled from 1 to 5. A higher score indicates more fatigue.
Measured: Baseline and after 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 May 2024
- Primary completionDec 2026 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Swedish School of Sport and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, Karolinska Institutet, Prostate Cancer Foundation, Sahlgrenska University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449664
- Sponsor's protocol ID
- 2024-00964-01
- Acronym
- ADT-train
- Status last verified
- Jun 2024
- First submitted
- 4 Apr 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADT-Train - A New Training Concept for Men With Prostate Cancer Receiving Androgen Deprivation Therapy.
- ClinicalTrials.gov ID
- NCT06449664
- Acronym / sponsor ID
- ADT-train / 2024-00964-01
- Conditions
- Prostate Cancer
- Keywords
- Androgen deprivation therapy (ADT), Flywheel training, High intensity training (HIT), Resistance training, Aerobic training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Swedish School of Sport and Health SciencesUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, Karolinska Institutet, Prostate Cancer Foundation, Sahlgrenska University Hospital
- Study start
- 1 May 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 10 Jun 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 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.
Detailed description
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ADT-trainThe participants will exercise twice weekly performing the newly developed training concept including flywheel resistance training followed by aerobic cycling intervals. |
| Control group | No intervention | –The participants will receive usual care only. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| ADT-trainA new training concept is tested on men with prostate cancer receiving androgen deprivation therapy | Behavioural | Exercise |
Primary outcome
Aerobic fitness
Time frame: Baseline and after 6 and 12 weeks
VO2peak (ml/kg/min); incremental ramp test on a cycle ergometer
Maximal leg strength
Time frame: Baseline and after 6 and 12 weeks
Isometric squat test (N) measured on force plates
27 secondary outcomes
Body fat
Time frame: Baseline and after 6 and 12 weeks
Lean body mass
Time frame: Baseline and after 6 and 12 weeks
Bone mineral density
Time frame: Baseline and after 6 and 12 weeks
Quadriceps cross-sectional area
Time frame: Baseline and after 6 and 12 weeks
Static balance
Time frame: Baseline and after 6 and 12 weeks
Walk capacity
Time frame: Baseline and after 6 and 12 weeks
Lower body muscular endurance
Time frame: Baseline and after 6 and 12 weeks
Blood pressure
Time frame: Baseline and after 6 and 12 weeks
Whole body glucose uptake
Time frame: Baseline and after 6 and 12 weeks
Whole body insulin response
Time frame: Baseline and after 6 and 12 weeks
Blood biomarkers related to cardiovascular disease.
Time frame: Baseline and after 6 and 12 weeks
Muscle fiber cross-sectional area (CSA)
Time frame: Baseline and after 12 weeks
Muscle fiber distribution
Time frame: Baseline and after 12 weeks
Capillary content
Time frame: Baseline and after 12 weeks
Myonuclei content
Time frame: Baseline and after 12 weeks
Satellite cell content
Time frame: Baseline and after 12 weeks
Mitochondrial content
Time frame: Baseline and after 12 weeks
Mitochondrial respiration
Time frame: Baseline and after 12 weeks
Genome-wide DNA methylation
Time frame: Baseline and after 12 weeks
Transcriptome-wide RNA expression
Time frame: Baseline and after 12 weeks
Protein expression
Time frame: Baseline and after 12 weeks
Gene expression
Time frame: Baseline and after 12 weeks
Cancer treatment-related symptoms
Time frame: Baseline and after 6 and 12 weeks
Physical activity
Time frame: Baseline and after 6 and 12 weeks
Physical and psychological health
Time frame: Baseline and after 6 and 12 weeks
Anxiety and depression
Time frame: Baseline and after 6 and 12 weeks
Cancer and treatment-related fatigue
Time frame: Baseline and after 6 and 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 10 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADT-train in people with Prostate Cancer, run by The Swedish School of Sport and Health Sciences at 1 site in Sweden.
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 3 inclusion and 5 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 10 Jun 2024. 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 Sweden. 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?
Contact Niklas Psilander, PhD (+46 8 120 538 23, niklas.psilander@gih.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic fitness (time frame: Baseline and after 6 and 12 weeks). The study lists 2 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 10 Jun 2024.