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SarcopeniaMASS-ADTNCT07134439

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

An observational study of Sarcopenia and Prostate Cancer, run by Guy's and St Thomas' NHS Foundation Trust.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older, men only
Conditions the study is for
Sarcopenia, Prostate Cancer, Muscle Atrophy
How many people
20 participants
Where
No sites listed yet
Study dates
Sep 2025to Dec 2026
Phase
Observational

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 65 years and older
  • Men only
  • No healthy volunteers
  • Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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
  • Exclusion criteria for those consenting to optional muscle biopsy:
  • On treatment with clopidogrel, high-dose aspirin, dipyridamole or anticoagulants
  • Known bleeding disorder or platelets <75x103/mL

About this study

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.

Read the detailed description

Androgen Deprivation Therapy (ADT) is a well-established therapy for prostate cancer that improves overall survival rates, reduced rates of metastatic prostate cancer and death from prostate cancer . ADT is most commonly delivered through medical castration. It works due to the sensitivity of prostate cancer to androgen signalling. Gonadotropin-releasing hormone (GnRH) agonists or antagonists are used to lower systemic testosterone and oestrogen levels and thereby control the prostate cancer. However, the reduction of these hormones can lead to systemic side-effects including changes in body composition such as increased fat mass and reduced muscle mass and subsequently result in sarcopenia and metabolic side-effects.

Sarcopenia is a condition underpinned by profound reductions in muscle mass and quality that occur in such sufficient magnitude as to lead to impairments in muscle function, independence and mobility. Moreover, sarcopenia is known to increase risk of falls, lead to impairments in quality of life, and increase mortality (independent of activities of daily living, age, and other factors). Resistance exercise is the gold standard treatment for sarcopenia, although this non-pharmacological stimulus has been shown to increase testosterone levels. Despite the potential rise in testosterone levels, resistance exercise has been shown to improve prostate cancer-specific mortality as well as providing functional benefits. Thus, additional downstream pathways are likely upregulated during the ageing process in older men undergoing Androgen Deprivation Therapy .

Ageing is a heterogenous process characterised by cellular senescence, telomere shortening, systemic inflammation and mitochondrial dysfunction and other "hallmarks of ageing". In animal models it has been shown that targeting these processes can extend healthspan and reduce the development of age-related conditions. There are small scale studies in humans trialling the use of drugs that target these ageing processes, known as geroprotectors. However, the fundamental mechanisms underpinning skeletal muscle atrophy and changes in body composition in patients undergoing ADT for prostate cancer are not well understood.

This study will assess the feasibility and acceptability of an observational cohort study to identify the fundamental mechanisms by which ADT is associated with changes in body composition following ADT in older adults with prostate cancer. Older adults are the focus of this study as the risk of side effects from ADT increases with age and the older population is poorly represented in research, including in research with prostate cancer populations . By identifying what processes may be involved in muscle atrophy following ADT, we will be able to better understand how to prevent this occurring and potentially target these pathways using geroprotectors.

Medical subject headings
Sarcopenia, Prostatic Neoplasms, Muscular Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07134439
Study groupRoleWhat they receive
Men undergoing Androgen Deprivation Therapy for the treatment of prostate cancerNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment and retention rate

    Measured: 6 months

Secondary outcomes (12)
  1. Rectus femoris ultrasound echogenicity at four-six months, adjusting for baseline echogenicity readings.

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

  6. Handgrip strength at four-six months, adjusting for baseline strength

    Measured: 6 months

  7. Quadriceps strength outcomes using isokinetic dynamometry, adjusting for baseline strength

    Measured: 6 months

  8. Short physical performance battery (SPPB) at four-six months, adjusting for baseline SPPB

    Measured: 6 months

  9. Lower limb muscular power measured by the vertical jump test at four-six months, adjusting for baseline power

    Measured: 6 months

  10. European Organisation For Research And Treatment Of Cancer (EORTC) Core Quality of Life questionnaire score at four-six, adjusting for baseline score.

    Measured: 6 months

  11. Biological markers of accelerated ageing

    Measured: 6 months

  12. Frailty level

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07134439
Sponsor's protocol ID
353219
Acronym
MASS-ADT
Status last verified
Aug 2025
First submitted
14 Aug 2025
Last updated
21 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33467296
  • 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.

    PubMed 36599349
  • 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.

    PubMed 30312372
  • 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.

    PubMed 27470918
  • 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.

    PubMed 20091248

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