Prostate CancerNCT07768917
Training on Systemic and Organ Spec. PM in PC
A study testing Exercise in people with Prostate Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research is being done to assess the impact of a supervised and structured strength and conditioning program on cardiac remodeling in participants with prostate cancer undergoing treatment with external beam radiation therapy and at least 6 months of Gonadotropin-releasing hormone (GnRH) therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2026to 31 Mar 2027
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have histologically or cytologically confirmed adenocarcinoma of the prostate
- Have not received GnRH agonist or antagonist within the last 12 months
- Planned for initiation of a GnRH agonist or antagonist or bilateral orchiectomy with an intended treatment duration of ≥ 6 months
- Planned for initiation of radiation therapy to the prostate.
- ECOG performance status of 0 or 1
- Ability to understand and the willingness to sign a written informed consent document
- Baseline serum total testosterone level > 230 ng/dL (the accepted threshold for testosterone supplementation)
- Speak English ->18 years of age
Who cannot join
- Has a known medical condition that makes the subject unable to participate in exercise testing (e.g. unrevascularized coronary artery disease, moderate/severe osteoarthritis, prior stroke, or other conditions)
- Receiving or planned to receive other cancer therapy not included in Eligibility Criterion 3.1.3 (other than an antiandrogen during the first month of therapy)
- The following populations will not be considered for inclusion on this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
Peter Lee, MD, PhD, 617-724-4000, plee22@mgh.harvard.edu
About this study
Official title: Impact of Prescribed Physical Training on Systemic and Organ Specific Prognostic Markers in Prostate Cancer
This research is being done to assess the impact of a supervised and structured strength and conditioning program on cardiac remodeling in participants with prostate cancer undergoing treatment with external beam radiation therapy and at least 6 months of Gonadotropin-releasing hormone (GnRH) therapy.
Read the detailed description
This study is designed to determine the impact of a strength and conditioning program on cardiac remodeling in participants with prostate cancer undergoing treatment with external beam radiation therapy and at least 6 months of Gonadotropin-releasing hormone (GnRH) therapy. In this study the participants will complete an exercise program that includes structured strength and conditioning programs which may include weightlifting, running, cycling, and stretching. During the research study participants will have data collected and blood samples taken which will be used to evaluate the prevention and reduction of potential harms induced by prostate cancer treatment. Participants will be in this research for 7 months which includes 6-months of the exercise intervention along with 1-month post-intervention activities. It is expected that about 20 people will take part in this research study.
- Conditions
- Prostate Cancer
- Being tested
- Exercise
- Keywords
- Prescribed Physical Training, Exercise Program, Systemic and Organ Specific Prognostic Markers in Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Supervised and structured strength and conditioning program
| Study group | Role | What they receive |
|---|---|---|
| Exercise Program | Other | Participants will undergo a 6-month exercise program. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction
Left ventricular ejection fraction (%) as measured by echocardiogram
Measured: At the start of the exercise program for up to 6 month after exercise program.
Left Ventricular Mass
Left ventricular mass (g) as measured by echocardiogram
Measured: Time Frame: At the start of the exercise program for up to 6 month after exercise program.
Left Ventricular Mass Index (g/m2)
Left ventricular mass index (g/m2) as measured by echocardiogram
Measured: Time Frame: At the start of the exercise program for up to 6 month after exercise program.
Posterior cardiac wall thickness (mm)
Posterior cardiac wall thickness (mm) as measured by echocardiogram.
Measured: Time Frame: At the start of the exercise program for up to 6 month after exercise program.
Relative cardiac wall thickness (ratio)
Relative cardiac wall thickness (ratio) as measured by echocardiogram
Measured: Time Frame: At the start of the exercise program for up to 6 month after exercise program.
Left ventricular end-diastolic and end-systolic dimension (mm)
Left ventricular end-diastolic and end-systolic dimension (mm) as measured by echocardiogram.
Measured: Time Frame: At the start of the exercise program for up to 6 month after exercise program.
Cardiac output (L/min)
Cardiac output (L/min) as measured by echocardiogram.
Measured: Time Frame: At the start of the exercise program for up to 6 month after exercise program.
Heart rate (bpm)
Heart rate (bpm) as measured by Cardiopulmonary Exercise Testing
Measured: Time Frame: At the start of the exercise program for up to 6 month after exercise program.
Blood pressure, systolic and diastolic (mmHg)
Blood pressure, systolic and diastolic (mmHg) as measured at Cardiopulmonary Exercise Testing
Measured: Time Frame: At the start of the exercise program for up to 6 month after exercise program.
VO2max (mL/kg/min)
VO2max (mL/kg/min) as measured on Cardiopulmonary Exercise Testing
Measured: Time Frame: At the start of the exercise program for up to 6 month after exercise program.
C-reactive protein (mg/L)
C-reactive protein (mg/L) measured by blood draw
Measured: Time Frame: At the start of the exercise program for up to 1 month after exercise program.
Erythrocyte sedimentation rate (mm/hr)
Erythrocyte sedimentation rate (mm/hr) measured by blood draw
Measured: Time Frame: At the start of the exercise program for up to 1 month after exercise program.
Neutrophil lymphocyte ratio (ratio)
Neutrophil lymphocyte ratio (ratio) as measured from blood draw values
Measured: Time Frame: At the start of the exercise program for up to 1 month after exercise program.
Systemic immune-inflammation index (SII)
Systemic immune-inflammation index (SII) as derived from blood draw values
Measured: Time Frame: At the start of the exercise program for up to 1 month after exercise program.
Hand grip strength (kg)
Hand grip strength (kg) measured by dynamometer
Measured: Time Frame: At the start of the exercise program for up to 1 month after exercise program.
Timed up and go test (seconds)
Timed up and go test (seconds) measured by stopwatch during exercise testing.
Measured: Time Frame: At the start of the exercise program for up to 1 month after exercise program.
Fatigue and health related quality of life (SF-36 questionnaire)
Fatigue and health related quality of life (SF-36 questionnaire) measured by standardized patient questionnaire.
Measured: Time Frame: At the start of the exercise program for up to 1 month after exercise program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start10 Dec 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (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 Massachusetts General HospitalThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Lee, Massachusetts General Hospital
- Investigators
- Peter Lee, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768917
- Sponsor's protocol ID
- 26-268
- Status last verified
- Aug 2026
- First submitted
- 30 Jun 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Request may be directed to Peter Lee, MD, PhD. The protocol and statistical analysis plan will be made available on ClinicalTrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prescribed Physical Training on Systemic and Organ Specific Prognostic Markers in Prostate Cancer
- ClinicalTrials.gov ID
- NCT07768917
- Acronym / sponsor ID
- 26-268
- Conditions
- Prostate Cancer
- Keywords
- Prescribed Physical Training, Exercise Program, Systemic and Organ Specific Prognostic Markers in Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 10 Dec 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 17 Aug 2026 (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.
This research is being done to assess the impact of a supervised and structured strength and conditioning program on cardiac remodeling in participants with prostate cancer undergoing treatment with external beam radiation therapy and at least 6 months of Gonadotropin-releasing hormone (GnRH) therapy.
Detailed description
This study is designed to determine the impact of a strength and conditioning program on cardiac remodeling in participants with prostate cancer undergoing treatment with external beam radiation therapy and at least 6 months of Gonadotropin-releasing hormone (GnRH) therapy. In this study the participants will complete an exercise program that includes structured strength and conditioning programs which may include weightlifting, running, cycling, and stretching. During the research study participants will have data collected and blood samples taken which will be used to evaluate the prevention and reduction of potential harms induced by prostate cancer treatment. Participants will be in this research for 7 months which includes 6-months of the exercise intervention along with 1-month post-intervention activities. It is expected that about 20 people will take part in this research study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Program | Other | Other: ExerciseParticipants will undergo a 6-month exercise program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have histologically or cytologically confirmed adenocarcinoma of the prostate
- Have not received GnRH agonist or antagonist within the last 12 months
- Planned for initiation of a GnRH agonist or antagonist or bilateral orchiectomy with an intended treatment duration of ≥ 6 months
- Planned for initiation of radiation therapy to the prostate.
- ECOG performance status of 0 or 1
Key exclusion criteria (3 listed)
- Has a known medical condition that makes the subject unable to participate in exercise testing (e.g. unrevascularized coronary artery disease, moderate/severe osteoarthritis, prior stroke, or other conditions)
- Receiving or planned to receive other cancer therapy not included in Eligibility Criterion 3.1.3 (other than an antiandrogen during the first month of therapy)
- The following populations will not be considered for inclusion on this trial.
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 |
|---|---|---|
| ExerciseSupervised and structured strength and conditioning program | Other | Exercise Program |
Primary outcome
Left Ventricular Ejection Fraction
Time frame: At the start of the exercise program for up to 6 month after exercise program.
Left ventricular ejection fraction (%) as measured by echocardiogram
Left Ventricular Mass
Time frame: Time Frame: At the start of the exercise program for up to 6 month after exercise program.
Left ventricular mass (g) as measured by echocardiogram
Left Ventricular Mass Index (g/m2)
Time frame: Time Frame: At the start of the exercise program for up to 6 month after exercise program.
Left ventricular mass index (g/m2) as measured by echocardiogram
Posterior cardiac wall thickness (mm)
Time frame: Time Frame: At the start of the exercise program for up to 6 month after exercise program.
Posterior cardiac wall thickness (mm) as measured by echocardiogram.
Relative cardiac wall thickness (ratio)
Time frame: Time Frame: At the start of the exercise program for up to 6 month after exercise program.
Relative cardiac wall thickness (ratio) as measured by echocardiogram
Left ventricular end-diastolic and end-systolic dimension (mm)
Time frame: Time Frame: At the start of the exercise program for up to 6 month after exercise program.
Left ventricular end-diastolic and end-systolic dimension (mm) as measured by echocardiogram.
Cardiac output (L/min)
Time frame: Time Frame: At the start of the exercise program for up to 6 month after exercise program.
Cardiac output (L/min) as measured by echocardiogram.
Heart rate (bpm)
Time frame: Time Frame: At the start of the exercise program for up to 6 month after exercise program.
Heart rate (bpm) as measured by Cardiopulmonary Exercise Testing
Blood pressure, systolic and diastolic (mmHg)
Time frame: Time Frame: At the start of the exercise program for up to 6 month after exercise program.
Blood pressure, systolic and diastolic (mmHg) as measured at Cardiopulmonary Exercise Testing
VO2max (mL/kg/min)
Time frame: Time Frame: At the start of the exercise program for up to 6 month after exercise program.
VO2max (mL/kg/min) as measured on Cardiopulmonary Exercise Testing
C-reactive protein (mg/L)
Time frame: Time Frame: At the start of the exercise program for up to 1 month after exercise program.
C-reactive protein (mg/L) measured by blood draw
Erythrocyte sedimentation rate (mm/hr)
Time frame: Time Frame: At the start of the exercise program for up to 1 month after exercise program.
Erythrocyte sedimentation rate (mm/hr) measured by blood draw
Neutrophil lymphocyte ratio (ratio)
Time frame: Time Frame: At the start of the exercise program for up to 1 month after exercise program.
Neutrophil lymphocyte ratio (ratio) as measured from blood draw values
Systemic immune-inflammation index (SII)
Time frame: Time Frame: At the start of the exercise program for up to 1 month after exercise program.
Systemic immune-inflammation index (SII) as derived from blood draw values
Hand grip strength (kg)
Time frame: Time Frame: At the start of the exercise program for up to 1 month after exercise program.
Hand grip strength (kg) measured by dynamometer
Timed up and go test (seconds)
Time frame: Time Frame: At the start of the exercise program for up to 1 month after exercise program.
Timed up and go test (seconds) measured by stopwatch during exercise testing.
Fatigue and health related quality of life (SF-36 questionnaire)
Time frame: Time Frame: At the start of the exercise program for up to 1 month after exercise program.
Fatigue and health related quality of life (SF-36 questionnaire) measured by standardized patient questionnaire.
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 17 Aug 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Request may be directed to Peter Lee, MD, PhD. The protocol and statistical analysis plan will be made available on ClinicalTrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Related trials for Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruiting
Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer
Malignant Prostate Neoplasm
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingObservational study
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Prostatic Neoplasms, Prostate Cancer
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
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.
Peter Lee, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Prostate Cancer, run by Massachusetts General Hospital at 1 site in United States.
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 8 inclusion and 3 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 17 Aug 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 States. 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?
Contact Peter J. Lee, MD, PhD (617-724-4000, plee22@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Ejection Fraction (time frame: At the start of the exercise program for up to 6 month after exercise program.). The study lists 17 primary outcomes in all. 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 17 Aug 2026.