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.
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
- 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 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 group | Role | What they receive |
|---|---|---|
| Men undergoing Androgen Deprivation Therapy for the treatment of prostate cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and retention rate
Measured: 6 months
Secondary outcomes (12)
Rectus femoris ultrasound echogenicity at four-six months, adjusting for baseline echogenicity readings.
Measured: 6 months
Ultrasound Bilateral Anterior Thigh Thickness (BATT) at four-six months, adjusting for baseline BATT
Measured: 6 months
Bilateral anterior thigh subcutaneous tissue thickness at four-six months, adjusting for baseline thickness
Measured: 6 months
Skeletal muscle mass (SMM) assessed using bioelectrical impedance analysis (BIA) at four-six months, adjusting for baseline SMM
Measured: 6 months
Fat mass from BIA at four-six months, adjusting for baseline fat mass
Measured: 6 months
Handgrip strength at four-six months, adjusting for baseline strength
Measured: 6 months
Quadriceps strength outcomes using isokinetic dynamometry, adjusting for baseline strength
Measured: 6 months
Short physical performance battery (SPPB) at four-six months, adjusting for baseline SPPB
Measured: 6 months
Lower limb muscular power measured by the vertical jump test at four-six months, adjusting for baseline power
Measured: 6 months
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
Biological markers of accelerated ageing
Measured: 6 months
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.
- First posted21 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
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 33467296Lopez-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 36599349Cruz-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 30312372Cao 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 27470918Haseen 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Fundamental Mechanisms of Skeletal Muscle Ageing in Older Men Undergoing Androgen Deprivation Therapy: a Feasibility Study
- ClinicalTrials.gov ID
- NCT07134439
- Acronym / sponsor ID
- MASS-ADT / 353219
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Aug 2025 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men undergoing Androgen Deprivation Therapy for the treatment of prostate cancer | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Men >= 65 years old who are starting Androgen Deprivation Therapy for treatment of prostate cancer
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recruitment and retention rate
Time frame: 6 months
12 secondary outcomes
Rectus femoris ultrasound echogenicity at four-six months, adjusting for baseline echogenicity readings.
Time frame: 6 months
Ultrasound Bilateral Anterior Thigh Thickness (BATT) at four-six months, adjusting for baseline BATT
Time frame: 6 months
Bilateral anterior thigh subcutaneous tissue thickness at four-six months, adjusting for baseline thickness
Time frame: 6 months
Skeletal muscle mass (SMM) assessed using bioelectrical impedance analysis (BIA) at four-six months, adjusting for baseline SMM
Time frame: 6 months
Fat mass from BIA at four-six months, adjusting for baseline fat mass
Time frame: 6 months
Handgrip strength at four-six months, adjusting for baseline strength
Time frame: 6 months
Quadriceps strength outcomes using isokinetic dynamometry, adjusting for baseline strength
Time frame: 6 months
Short physical performance battery (SPPB) at four-six months, adjusting for baseline SPPB
Time frame: 6 months
Lower limb muscular power measured by the vertical jump test at four-six months, adjusting for baseline power
Time frame: 6 months
European Organisation For Research And Treatment Of Cancer (EORTC) Core Quality of Life questionnaire score at four-six, adjusting for baseline score.
Time frame: 6 months
Biological markers of accelerated ageing
Time frame: 6 months
Frailty level
Time frame: 6 months
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 21 Aug 2025.
- Background: PubMed 33467296Riachy 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.
- Background: PubMed 36599349Lopez-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.
- Background: PubMed 30312372Cruz-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.
- Background: PubMed 27470918Cao 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.
- Background: PubMed 20091248Haseen 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Prostate Cancer, run by Guy's and St Thomas' NHS Foundation Trust.
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 4 inclusion and 7 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 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and retention rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07134439, which also lists 5 linked publications.
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 21 Aug 2025.