Clinical trial · Observational
Identifying Fundamental Mechanisms of Skeletal Muscle Ageing in Older Men Undergoing Androgen Deprivation Therapy: a Feasibility Study
NCT07134439CI-TRIAL-00093937MASS-ADTnot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Androgen Deprivation Therapy | — | UNRESOLVED | — |
| Muscle Atrophy | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Sarcopenia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Men undergoing Androgen Deprivation Therapy for the treatment of prostate cancer
Primary outcomes (1)
- measure
- Recruitment and retention rate
- timeFrame
- 6 months
Secondary outcomes (12)
- measure
- Rectus femoris ultrasound echogenicity at four-six months, adjusting for baseline echogenicity readings.
- timeFrame
- 6 months
- measure
- Ultrasound Bilateral Anterior Thigh Thickness (BATT) at four-six months, adjusting for baseline BATT
- timeFrame
- 6 months
- measure
- Bilateral anterior thigh subcutaneous tissue thickness at four-six months, adjusting for baseline thickness
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (5)
- BACKGROUNDRiachy 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
- BACKGROUNDLopez-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
- BACKGROUNDCruz-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
- BACKGROUNDCao 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
- BACKGROUNDHaseen 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