Identifying Fundamental Mechanisms of Skeletal Muscle Ageing in Older Men Undergoing Androgen Deprivation Therapy: a Feasibility Study

NCT07134439 | Not Yet Recruiting

• 1 other identifier: 353219
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

To find out whether it is possible to run a study looking at the underlying markers of ageing in muscle quality and quantity in men receiving Androgen Deprivation Therapy for prostate cancer treatment. To determine the feasibility of conducting an observational study examining the association of fundamental biological markers of ageing with changes in body composition and skeletal muscle morphology following ADT in older men undergoing prostate cancer treatment.

Conditions

Sarcopenia; Prostate Cancer; Muscle Atrophy; Androgen Deprivation Therapy

Outcome Measures

Primary Outcomes (1)

• Recruitment and retention rate

  6 months

Secondary Outcomes (12)

• Rectus femoris ultrasound echogenicity at four-six months, adjusting for baseline echogenicity readings.

  6 months

• Ultrasound Bilateral Anterior Thigh Thickness (BATT) at four-six months, adjusting for baseline BATT

  6 months

• Bilateral anterior thigh subcutaneous tissue thickness at four-six months, adjusting for baseline thickness

  6 months

• Skeletal muscle mass (SMM) assessed using bioelectrical impedance analysis (BIA) at four-six months, adjusting for baseline SMM

  6 months

• Fat mass from BIA at four-six months, adjusting for baseline fat mass

  6 months

Study Arms (1)

Men undergoing Androgen Deprivation Therapy for the treatment of prostate cancer

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men \>= 65 years old who are starting Androgen Deprivation Therapy for treatment of prostate cancer

You may qualify if:

• Age ≥65 years old at time of recruitment
• Able to provide informed consent to participate
• Known prostate cancer due to be initiated on ADT for the first time (with or without Androgen Receptor Targeted Agents (ARTA) or radiotherapy), or initiated within two weeks prior to recruitment.
• Individuals involved in other research will be eligible to participate so long as the other research does not involve potential changes to the standard ADT care the participant will be receiving and does not involve an intervention aimed at reducing the muscle atrophy associated with ADT.

You may not qualify if:

• Systemic anti-cancer therapy within one year of recruitment (for prostate cancer or any other concomitant cancer)
• Planned surgery (not including eye surgery or other minor surgery) within six months of ADT
• Any other condition previous or current which, in the judgement of the responsible clinician, is likely to interfere with the trial / assessments.
• Lacks capacity to consent
• On treatment with clopidogrel, high-dose aspirin, dipyridamole or anticoagulants
• Known bleeding disorder or platelets \<75x103/mL

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

Related Publications (5)

• Riachy R, McKinney K, Tuvdendorj DR. Various Factors May Modulate the Effect of Exercise on Testosterone Levels in Men. J Funct Morphol Kinesiol. 2020 Nov 7;5(4):81. doi: 10.3390/jfmk5040081.

  PMID: 33467296 BACKGROUND

• Lopez-Otin C, Blasco MA, Partridge L, Serrano M, Kroemer G. Hallmarks of aging: An expanding universe. Cell. 2023 Jan 19;186(2):243-278. doi: 10.1016/j.cell.2022.11.001. Epub 2023 Jan 3.

  PMID: 36599349 BACKGROUND

• Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.

  PMID: 30312372 BACKGROUND

• Cao L, Morley JE. Sarcopenia Is Recognized as an Independent Condition by an International Classification of Disease, Tenth Revision, Clinical Modification (ICD-10-CM) Code. J Am Med Dir Assoc. 2016 Aug 1;17(8):675-7. doi: 10.1016/j.jamda.2016.06.001. No abstract available.

  PMID: 27470918 BACKGROUND

• Haseen F, Murray LJ, Cardwell CR, O'Sullivan JM, Cantwell MM. The effect of androgen deprivation therapy on body composition in men with prostate cancer: systematic review and meta-analysis. J Cancer Surviv. 2010 Jun;4(2):128-39. doi: 10.1007/s11764-009-0114-1. Epub 2010 Jan 21.

  PMID: 20091248 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, muscle biopsy samples

MeSH Terms

Conditions

Sarcopenia; Prostatic Neoplasms; Muscular Atrophy

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share