Prostate CancerADHERENCT07243834
Assessing a Digital Exercise Intervention for Health Outcomes and Engagement in Regular Exercise
A study testing Participation in a digital exercise intervention with virtual supervised group exercise sessions in people with Prostate Cancer and Prostate Cancer (Diagnosis), run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Patients diagnosed with prostate cancer and receiving hormone therapy in conjunction with radiotherapy are likely to suffer from adverse effects caused by ADT treatment either short term or long term. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer (Diagnosis)
- What is being tested?
- Participation in a digital exercise intervention with virtual supervised group exercise sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Dec 2025to 28 Apr 2030
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 at randomisation
- Men with histological confirmation of prostate adenocarcinoma who are receiving or planned to receive ADT with an LHRHa as part of their PCa treatment
- If already started ADT, have received no more than eight weeks ADT at randomisation
- Planned for radiotherapy
- Assessed by clinical team to be safe to exercise and safe to enter the trial with no absolute contraindications to exercise as defined by clinical guidance
- Able to use technological aspects of the intervention including access to MyMarsden and a device for video conferencing
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- Fluent in English and able to understand instructions
- WHO performance status 0-2
- Able to give written informed consent
Who cannot join
- Men planned to receive an androgen receptor-targeted agent (ARTA) or chemotherapy
- Absolute contraindication to exercise as defined by ACPICR standards. This includes:
- New symptoms of angina
- New or unstable heart failure
- Newly diagnosed diabetes that is not controlled
- New or untreated arrhythmias
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- Resting tachycardia or new bradycardia (not linked to changes in medications)
- Symptomatic hypotension
- Uncontrolled hypertension (SBP ≥ 180mmHg or DBP≥ 100mmHg)
- Unstable spinal bone metastasis or at high risk of a fracture
- Musculoskeletal issue inhibiting exercise
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden Hospital
London, SW3 6JJ
Sijy Pillai, 02078118116, adhere.trial@rmh.nhs.uk
About this study
Official title: Assessing a Digital Exercise Intervention for Health Outcomes and Engagement in Regular Exercise (ADHERE): A Randomised Controlled Trial Comparing the Efficacy of a Digital Exercise Intervention With Virtual Supervised Group Exercise Sessions to Standard of Care on Exercise Adherence at Six Months in Patients With Prostate Cancer Undergoing Hormone Therapy.
Patients diagnosed with prostate cancer and receiving hormone therapy in conjunction with radiotherapy are likely to suffer from adverse effects caused by ADT treatment either short term or long term. The most common side effects include changes in body composition leading to increased visceral fat and reduced lean muscle mass, increased risk of cardiovascular events and fatigue, which overall lower quality of life.
There is strong evidence to support exercise interventions in minimising, and in some cases reversing many ADT -related toxicities, but exercise adherence remains a challenge for people living with prostate cancer, particularly due to logistical barriers to attendance such as cost and travel time, as well as insufficient motivation.
Read more
The aim of this single centre, phase III randomised controlled trial is to assess the efficacy of a new digital exercise programme with virtual supervised group exercise sessions in improving adherence to exercise guidelines.
The trial aims to recruit 160 participants with prostate cancer undergoing ADT, who will be allocated either the standard of care group or standard of care plus participation in the digital exercise intervention on a 1:1 ratio.
Adherence to physical activity will be measured using a wearable accelerometer, an exercise diary, self-reported questionnaires and clinic based assessments at 3 months, 6 months and 12 months post radiotherapy treatment. Recruitment will take place at the Royal Marsden NHS Foundation Trust, Chelsea.
- Conditions
- Prostate Cancer, Prostate Cancer (Diagnosis)
- Being tested
- Participation in a digital exercise intervention with virtual supervised group exercise sessions
- Keywords
- Exercise intervention, physical activity, adherence
- Medical subject headings
- Prostatic Neoplasms, Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participation in a digital exercise intervention with virtual supervised group exercise sessionsOther
Also called Exercise intervention
The intervention will involve an initial individual review with a clinical exercise physiologist (CEP) to complete a screening questionnaire, set goals and discuss details of physical activity and the exercise plan.
Participants will then attend weekly virtual supervised group exercise sessions and have access to pre-recorded exercise videos as well. Participants will receive motivational emails after each group session and have check-in phone calls with the CEP at week 4 and week 8.
Participants will also have the option to take part in the patient buddy scheme which includes three support phone calls from a fellow patient at The Royal Marsden NHS Foundation Trust. One phone call will be scheduled at the start of the exercise programme, one halfway through the programme, and one at the end of the programme.
Individual review appointments with the CEP will be scheduled at Week 13 and Week 26 to review progress and address any barriers to exercise adherence.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SoC) | No intervention | Participants will be sent a link to a webpage which provides information on physical activity and exercise guidelines, local and nationally available exercise, and contact details for the RMH physiotherapy department with the option to self-refer for further support. |
| SoC + digital exercise intervention with virtual supervised group exercise sessions | Experimental | Participants will receive standard of care and a digital exercise intervention. Receives: Other: Participation in a digital exercise intervention with virtual supervised group exercise sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is adherence to physical activity and exercise guidelines assessed using device-based activity data and self-reported physical activity and exercise data at six-months post-radiotherapy.
Activity data will be measured using the ActiGraph LEAP wearable activity monitor and an Exercise Diary.
To calculate physical activity and exercise adherence, we will compare the measured total volume of physical activity compared to the target volume of physical activity.
Measured: Measured at six months post radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start16 Dec 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion28 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243834
- Sponsor's protocol ID
- CCR6225
- Acronym
- ADHERE
- Status last verified
- Jan 2026
- First submitted
- 17 Nov 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing a Digital Exercise Intervention for Health Outcomes and Engagement in Regular Exercise (ADHERE): A Randomised Controlled Trial Comparing the Efficacy of a Digital Exercise Intervention With Virtual Supervised Group Exercise Sessions to Standard of Care on Exercise Adherence at Six Months in Patients With Prostate Cancer Undergoing Hormone Therapy.
- ClinicalTrials.gov ID
- NCT07243834
- Acronym / sponsor ID
- ADHERE / CCR6225
- Conditions
- Prostate Cancer, Prostate Cancer (Diagnosis)
- Keywords
- Exercise intervention, physical activity, adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 28 Apr 2030 (estimated)
- First posted
- 24 Nov 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.
Patients diagnosed with prostate cancer and receiving hormone therapy in conjunction with radiotherapy are likely to suffer from adverse effects caused by ADT treatment either short term or long term. The most common side effects include changes in body composition leading to increased visceral fat and reduced lean muscle mass, increased risk of cardiovascular events and fatigue, which overall lower quality of life.
There is strong evidence to support exercise interventions in minimising, and in some cases reversing many ADT -related toxicities, but exercise adherence remains a challenge for people living with prostate cancer, particularly due to logistical barriers to attendance such as cost and travel time, as well as insufficient motivation.
The aim of this single centre, phase III randomised controlled trial is to assess the efficacy of a new digital exercise programme with virtual supervised group exercise sessions in improving adherence to exercise guidelines.
The trial aims to recruit 160 participants with prostate cancer undergoing ADT, who will be allocated either the standard of care group or standard of care plus participation in the digital exercise intervention on a 1:1 ratio.
Adherence to physical activity will be measured using a wearable accelerometer, an exercise diary, self-reported questionnaires and clinic based assessments at 3 months, 6 months and 12 months post radiotherapy treatment. Recruitment will take place at the Royal Marsden NHS Foundation Trust, Chelsea.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SoC) | No intervention | –Participants will be sent a link to a webpage which provides information on physical activity and exercise guidelines, local and nationally available exercise, and contact details for the RMH physiotherapy department with the option to self-refer for further support. |
| SoC + digital exercise intervention with virtual supervised group exercise sessions | Experimental | Other: Participation in a digital exercise intervention with virtual supervised group exercise sessionsParticipants will receive standard of care and a digital exercise intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 at randomisation
- Men with histological confirmation of prostate adenocarcinoma who are receiving or planned to receive ADT with an LHRHa as part of their PCa treatment
- If already started ADT, have received no more than eight weeks ADT at randomisation
- Planned for radiotherapy
- Assessed by clinical team to be safe to exercise and safe to enter the trial with no absolute contraindications to exercise as defined by clinical guidance
Key exclusion criteria (11 listed)
- Men planned to receive an androgen receptor-targeted agent (ARTA) or chemotherapy
- Absolute contraindication to exercise as defined by ACPICR standards. This includes:
- Unstable spinal bone metastasis or at high risk of a fracture
- Musculoskeletal issue inhibiting exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participation in a digital exercise intervention with virtual supervised group exercise sessionsAlso: Exercise interventionThe intervention will involve an initial individual review with a clinical exercise physiologist (CEP) to complete a screening questionnaire, set goals and discuss details of physical activity and the exercise plan. Participants will then attend weekly virtual supervised group exercise sessions and have access to pre-recorded exercise videos as well. Participants will receive motivational emails after each group session and have check-in phone calls with the CEP at week 4 and week 8. Participants will also have the option to take part in the patient buddy scheme which includes three support phone calls from a fellow patient at The Royal Marsden NHS Foundation Trust. One phone call will be scheduled at the start of the exercise programme, one halfway through the programme, and one at the end of the programme. Individual review appointments with the CEP will be scheduled at Week 13 and Week 26 to review progress and address any barriers to exercise adherence. | Other | SoC + digital exercise intervention with virtual supervised group exercise sessions |
Primary outcome
The primary endpoint is adherence to physical activity and exercise guidelines assessed using device-based activity data and self-reported physical activity and exercise data at six-months post-radiotherapy.
Time frame: Measured at six months post radiotherapy
Activity data will be measured using the ActiGraph LEAP wearable activity monitor and an Exercise Diary. To calculate physical activity and exercise adherence, we will compare the measured total volume of physical activity compared to the target volume of physical activity.
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 30 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participation in a digital exercise intervention with virtual supervised group exercise sessions in people with Prostate Cancer and Prostate Cancer (Diagnosis), run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 9 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is adherence to physical activity and exercise guidelines assessed using device-based activity data and self-reported physical activity and exercise data at six-months post-radiotherapy. (time frame: Measured at six months post radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2026.