Prostate CancerNCT07724080
Resistance Exercise, IL-7 and Immune Phenotypes in Prostate Cancer
A study testing Supervised Resistance Exercise Programme in people with Prostate Cancer and Muscle Loss, run by University of Bath at 1 site in United Kingdom.
Trial summary
Hormone therapy for prostate cancer typically causes significant muscle loss. Skeletal muscle releases Interleukin-7 (IL-7), a signalling protein that supports the production of new immune cells. Therefore, losing muscle during cancer treatment may actively weaken the immune system. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Muscle Loss
- What is being tested?
- Supervised Resistance Exercise Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2026to Sep 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of localised prostate cancer (clinical stage T1-3b, N0-1, M0 and a Gleason score of 6-10).
- Scheduled to undergo curative-intent treatment involving neoadjuvant androgen deprivation therapy (ADT) for a duration of at least 3 months, alongside radiotherapy.
- Recruited prior to, or within the first 2 weeks of, initiating ADT.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Written medical clearance to participate from the treating oncologist.
- Sufficient proficiency in English to comprehend study instructions.
- Provision of written informed consent.
Who cannot join
- Evidence of distant metastases (M1).
- Uncontrolled cardiovascular conditions (e.g., uncontrolled hypertension, unstable angina, or a myocardial infarction within the past 6 months).
- Musculoskeletal pathologies or conditions that would preclude the safe execution of resistance exercise.
- A known history of autoimmune disease.
- Current use of chronic systemic corticosteroids or other immunosuppressive agents.
- Engagement in structured resistance exercise within the preceding 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
University of Bath
Bath, Somerset, BA2 7AY
Fernando Alonso, 07760199388, fag34@bath.ac.uk
About this study
Official title: Effects of Resistance Exercise on IL-7 and Immune Cell Phenotypes in Men With Prostate Cancer Receiving Androgen Deprivation Therapy Prior to Radiotherapy: A Pilot Study
Hormone therapy for prostate cancer typically causes significant muscle loss. Skeletal muscle releases Interleukin-7 (IL-7), a signalling protein that supports the production of new immune cells. Therefore, losing muscle during cancer treatment may actively weaken the immune system. The goal of this clinical trial is to investigate if a 12-week supervised resistance exercise (strength training) programme can prevent this muscle loss and increase levels of IL-7.
The main questions it aims to answer are:
Read more
- Does a 12-week strength training programme raise resting IL-7 levels and increase newly formed immune cell counts?
- Does a single session of strength training trigger an immediate release of IL-7?
- To what extent do exercise-induced improvements in muscle mass and strength translate into reduced fatigue, better physical function, higher quality of life, and improved cardiometabolic health?
- Is the exercise programme safe and well-tolerated during hormone therapy?
Researchers will compare a Resistance Exercise Group to a Usual Care Group to see the effects of strength training against standard medical care.
Participants will:
- Attend a screening visit to check eligibility.
- Complete baseline assessments, including body composition scans, blood tests, fitness tests, and questionnaires.
- Be randomly assigned to either the exercise group or the usual care group.
- Complete three supervised strength training sessions per week for 12 weeks, if assigned to the exercise group.
- Continue with standard medical care, if assigned to the usual care group.
- Repeat all assessments at the end of the 12 weeks.
- Perform one short exercise session during the final visit, with extra blood samples taken before and after to track immediate changes
- Conditions
- Prostate Cancer, Muscle Loss
- Being tested
- Supervised Resistance Exercise Programme
- Keywords
- Prostate cancer, resistance exercise, androgen deprivation therapy, interleukin-7, immune function, prehabilitation
- Medical subject headings
- Prostatic Neoplasms, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Resistance Exercise ProgrammeOther
A 12-week, supervised resistance training programme delivered in small groups in a gym setting. Participants will train 3 times per week on non-consecutive days, with sessions lasting 45-60 minutes. The programme targets all major muscle groups, with volume and intensity gradually increasing throughout the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | No intervention | Participants receive standard medical care for 12 weeks. They do not participate in the supervised exercise sessions and are instructed not to initiate any new structured resistance exercise programme during the study period. |
| Resistance Exercise Group | Experimental | In addition to standard medical care, participants undergo a 12-week, supervised resistance exercise programme. Receives: Other: Supervised Resistance Exercise Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Resting Interleukin-7 (IL-7) Concentration
Assessed via enzyme-linked immunosorbent assay (ELISA) from resting, fasting blood samples to evaluate changes in baseline immune-supporting signaling proteins.
Measured: Baseline and 12 weeks
Secondary outcomes (24)
Change in Frequencies of Resting Immune Cell Phenotypes
Assessed via flow cytometry from resting, fasting blood samples to evaluate key immune cell populations, specifically naïve CD4+ T-cells, naïve CD8+ T-cells, and naïve B-cells.
Measured: Baseline and 12 weeks
Acute Circulating IL-7 Response to a Single Bout of Exercise
Quantified as the incremental Area Under the Curve (iAUC) of circulating IL-7 via ELISA. Blood samples are taken at rest, immediately post-exercise, and 30 minutes post-exercise.
Measured: Week 12
Change in Total Lean Mass
Measured via Dual-Energy X-ray Absorptiometry (DEXA) to evaluate changes in lean tissue.
Measured: Baseline and 12 weeks
Change in Total Fat Mass
Measured via Dual-Energy X-ray Absorptiometry (DEXA) to evaluate changes in body fat.
Measured: Baseline and 12 weeks
Change in Local Muscle Cross-Sectional Area (CSA)
Local muscle cross-sectional area (CSA) assessed via peripheral Quantitative Computed Tomography (pQCT) to assess changes in specific muscle size.
Measured: Baseline and 12 weeks
Change in Handgrip Strength
Measured using a hand dynamometer to assess upper-body isometric strength
Measured: Baseline, 12 weeks
Change in 30-Second Sit-to-Stand Test Performance
Evaluated by the number of sit-to-stand repetitions completed in 30 seconds to assess lower-body functional strength.
Measured: Baseline and 12 weeks
Change in Timed Up and Go (TUG) Test Performance
Assessed using the Timed Up and Go Test (TUG) to evaluate changes in functional mobility and balance.
Measured: Baseline and 12 weeks
Change in Leg Press Peak Power Output
Assessed using a Keiser leg press to determine peak power output
Measured: Baseline and 12 weeks
Change in Leg Press One-Repetition Maximum (1RM)
Assessed using a Keiser leg press to determine 1-repetition maximum (1RM).
Measured: Baseline and 12 weeks
Change in Glycated Haemoglobin (HbA1c)
Analyzed from resting, fasting blood samples to monitor long-term glycemic control.
Measured: Baseline and 12 weeks
Change in Fasting Insulin
Analyzed from resting, fasting blood samples to evaluate insulin levels and metabolic health
Measured: Baseline and 12 weeks
Change in Fasting Glucose
Analyzed from resting, fasting blood samples to evaluate baseline glycemic control
Measured: Baseline and 12 weeks
Change in C-Reactive Protein (CRP)
Analyzed from resting, fasting blood samples to assess baseline systemic inflammation.
Measured: Baseline and 12 weeks
Change in Cancer-Specific Quality of Life (EORTC QLQ-C30)
Evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores range from 0 to 100, where higher scores represent a better quality of life.
Measured: Baseline and 12 weeks
Change in Prostate Cancer-Specific Symptoms (EORTC QLQ-PR25)
Evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Prostate Cancer Module (EORTC QLQ-PR25). Scores range from 0 to 100, where higher scores represent higher symptom burden (worse outcome).
Measured: Baseline and 12 weeks
Change in Fatigue Severity (FACIT-Fatigue)
Evaluated using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale. Scores range from 0 to 52, where higher scores represent lower levels of fatigue (better outcome).
Measured: Baseline and 12 weeks
Uptake and Retention Rates
Uptake is calculated as the percentage of invited eligible patients who consent to participate. Retention is the percentage of randomised participants who successfully complete the final post-intervention assessments.
Measured: Through study completion
Incidence of Adverse Events
Total number and percentage of participants experiencing adverse events, systematically tracked and evaluated for seriousness and causality.
Measured: Throughout the 12-week intervention period
Exercise Session Attendance Rate
Calculated as the percentage of the total prescribed supervised exercise sessions successfully attended by the participants in the intervention group.
Measured: Throughout the 12-week intervention period
Resistance Exercise Dose Adherence
Calculated as the percentage of total prescribed exercise sets completed by the participants in the intervention group
Measured: Throughout the 12-week intervention period
Average Session Rate of Perceived Exertion (RPE)
Evaluated using the Borg Rating of Perceived Exertion (RPE) Category-Ratio scale (CR10). Scores range from 0 (no exertion at all) to 10 (maximal exertion), recorded at the end of each session and averaged for participants in the intervention group. Higher scores represent a higher perceived physical effort.
Measured: Throughout the 12-week intervention period
Frequency of Exercise Dose Reductions
Calculated as the percentage of attended exercise sessions where the prescribed volume or intensity had to be modified or reduced due to fatigue or intolerance in the intervention group.
Measured: Throughout the 12-week intervention period
Frequency of Exercise Interruptions
The total count of instances where a participant in the intervention group missed 3 or more consecutive scheduled exercise sessions.
Measured: Throughout the 12-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- Royal United Hospitals Bath NHS Foundation Trust
- Responsible party
- Principal investigator, John Campbell, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724080
- Sponsor's protocol ID
- 16161
- Other IDs
- 371008, 26/WA/0162
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 23 Jul 2026
- 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 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Exercise on IL-7 and Immune Cell Phenotypes in Men With Prostate Cancer Receiving Androgen Deprivation Therapy Prior to Radiotherapy: A Pilot Study
- ClinicalTrials.gov ID
- NCT07724080
- Acronym / sponsor ID
- 16161
- Conditions
- Prostate Cancer, Muscle Loss
- Keywords
- Prostate cancer, resistance exercise, androgen deprivation therapy, interleukin-7, immune function, prehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- Royal United Hospitals Bath NHS Foundation Trust
- Study start
- Aug 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 23 Jul 2026 (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.
Hormone therapy for prostate cancer typically causes significant muscle loss. Skeletal muscle releases Interleukin-7 (IL-7), a signalling protein that supports the production of new immune cells. Therefore, losing muscle during cancer treatment may actively weaken the immune system. The goal of this clinical trial is to investigate if a 12-week supervised resistance exercise (strength training) programme can prevent this muscle loss and increase levels of IL-7.
The main questions it aims to answer are:
- Does a 12-week strength training programme raise resting IL-7 levels and increase newly formed immune cell counts?
- Does a single session of strength training trigger an immediate release of IL-7?
- To what extent do exercise-induced improvements in muscle mass and strength translate into reduced fatigue, better physical function, higher quality of life, and improved cardiometabolic health?
- Is the exercise programme safe and well-tolerated during hormone therapy?
Researchers will compare a Resistance Exercise Group to a Usual Care Group to see the effects of strength training against standard medical care.
Participants will:
- Attend a screening visit to check eligibility.
- Complete baseline assessments, including body composition scans, blood tests, fitness tests, and questionnaires.
- Be randomly assigned to either the exercise group or the usual care group.
- Complete three supervised strength training sessions per week for 12 weeks, if assigned to the exercise group.
- Continue with standard medical care, if assigned to the usual care group.
- Repeat all assessments at the end of the 12 weeks.
- Perform one short exercise session during the final visit, with extra blood samples taken before and after to track immediate changes
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | No intervention | –Participants receive standard medical care for 12 weeks. They do not participate in the supervised exercise sessions and are instructed not to initiate any new structured resistance exercise programme during the study period. |
| Resistance Exercise Group | Experimental | Other: Supervised Resistance Exercise ProgrammeIn addition to standard medical care, participants undergo a 12-week, supervised resistance exercise programme. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed diagnosis of localised prostate cancer (clinical stage T1-3b, N0-1, M0 and a Gleason score of 6-10).
- Scheduled to undergo curative-intent treatment involving neoadjuvant androgen deprivation therapy (ADT) for a duration of at least 3 months, alongside radiotherapy.
- Recruited prior to, or within the first 2 weeks of, initiating ADT.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Written medical clearance to participate from the treating oncologist.
Key exclusion criteria (6 listed)
- Evidence of distant metastases (M1).
- Uncontrolled cardiovascular conditions (e.g., uncontrolled hypertension, unstable angina, or a myocardial infarction within the past 6 months).
- Musculoskeletal pathologies or conditions that would preclude the safe execution of resistance exercise.
- A known history of autoimmune disease.
- Current use of chronic systemic corticosteroids or other immunosuppressive agents.
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 |
|---|---|---|
| Supervised Resistance Exercise ProgrammeA 12-week, supervised resistance training programme delivered in small groups in a gym setting. Participants will train 3 times per week on non-consecutive days, with sessions lasting 45-60 minutes. The programme targets all major muscle groups, with volume and intensity gradually increasing throughout the intervention period. | Other | Resistance Exercise Group |
Primary outcome
Change in Resting Interleukin-7 (IL-7) Concentration
Time frame: Baseline and 12 weeks
Assessed via enzyme-linked immunosorbent assay (ELISA) from resting, fasting blood samples to evaluate changes in baseline immune-supporting signaling proteins.
24 secondary outcomes
Change in Frequencies of Resting Immune Cell Phenotypes
Time frame: Baseline and 12 weeks
Acute Circulating IL-7 Response to a Single Bout of Exercise
Time frame: Week 12
Change in Total Lean Mass
Time frame: Baseline and 12 weeks
Change in Total Fat Mass
Time frame: Baseline and 12 weeks
Change in Local Muscle Cross-Sectional Area (CSA)
Time frame: Baseline and 12 weeks
Change in Handgrip Strength
Time frame: Baseline, 12 weeks
Change in 30-Second Sit-to-Stand Test Performance
Time frame: Baseline and 12 weeks
Change in Timed Up and Go (TUG) Test Performance
Time frame: Baseline and 12 weeks
Change in Leg Press Peak Power Output
Time frame: Baseline and 12 weeks
Change in Leg Press One-Repetition Maximum (1RM)
Time frame: Baseline and 12 weeks
Change in Glycated Haemoglobin (HbA1c)
Time frame: Baseline and 12 weeks
Change in Fasting Insulin
Time frame: Baseline and 12 weeks
Change in Fasting Glucose
Time frame: Baseline and 12 weeks
Change in C-Reactive Protein (CRP)
Time frame: Baseline and 12 weeks
Change in Cancer-Specific Quality of Life (EORTC QLQ-C30)
Time frame: Baseline and 12 weeks
Change in Prostate Cancer-Specific Symptoms (EORTC QLQ-PR25)
Time frame: Baseline and 12 weeks
Change in Fatigue Severity (FACIT-Fatigue)
Time frame: Baseline and 12 weeks
Uptake and Retention Rates
Time frame: Through study completion
Incidence of Adverse Events
Time frame: Throughout the 12-week intervention period
Exercise Session Attendance Rate
Time frame: Throughout the 12-week intervention period
Resistance Exercise Dose Adherence
Time frame: Throughout the 12-week intervention period
Average Session Rate of Perceived Exertion (RPE)
Time frame: Throughout the 12-week intervention period
Frequency of Exercise Dose Reductions
Time frame: Throughout the 12-week intervention period
Frequency of Exercise Interruptions
Time frame: Throughout the 12-week intervention period
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 23 Jul 2026.
- 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 Supervised Resistance Exercise Programme in people with Prostate Cancer and Muscle Loss, run by University of Bath at 1 site in United Kingdom.
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 7 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: opening soon, as of the sponsor's last update on 23 Jul 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 United Kingdom. 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 Fernando Alonso (+447760199388, fag34@bath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Resting Interleukin-7 (IL-7) Concentration (time frame: Baseline and 12 weeks). 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 Jul 2026.