Resistance Exercise, IL-7 and Immune Phenotypes in Prostate Cancer

NCT07724080 | Not Yet Recruiting

• 3 other identifiers: 1616137100826/WA/0162
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Prostate Cancer; Muscle Loss

Keywords

Prostate cancer; resistance exercise; androgen deprivation therapy; interleukin-7; immune function; prehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 weeks

Secondary Outcomes (24)

• Change in Frequencies of Resting Immune Cell Phenotypes

  Baseline and 12 weeks

• Acute Circulating IL-7 Response to a Single Bout of Exercise

  Week 12

• Change in Total Lean Mass

  Baseline and 12 weeks

• Change in Total Fat Mass

  Baseline and 12 weeks

• Change in Local Muscle Cross-Sectional Area (CSA)

  Baseline and 12 weeks

Study Arms (2)

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.

Other: Supervised Resistance Exercise Programme

Interventions

Supervised Resistance Exercise Programme OTHER

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.

Resistance Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bath: lead
• Royal United Hospitals Bath NHS Foundation Trust: collaborator

Study Sites (1)

University of Bath

Bath, Somerset, BA2 7AY, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Muscular Atrophy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Fernando Alonso

CONTACT

+447760199388; fag34@bath.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 23, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

GB (1)