Training on Systemic and Organ Spec. PM in PC

NCT07768917 | Not Yet Recruiting DMC

• 1 other identifier: 26-268
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Prescribed Physical Training; Exercise Program; Systemic and Organ Specific Prognostic Markers in Prostate Cancer

Outcome Measures

Primary Outcomes (17)

• Left Ventricular Ejection Fraction

  Left ventricular ejection fraction (%) as measured by echocardiogram

  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

  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

  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.

  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

  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.

  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.

  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

  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

  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

  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

  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

  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

  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

  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

  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.

  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.

  Time Frame: At the start of the exercise program for up to 1 month after exercise program.

Study Arms (1)

Exercise Program

OTHER

Participants will undergo a 6-month exercise program.

Other: Exercise

Interventions

Exercise OTHER

Supervised and structured strength and conditioning program

Exercise Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Peter Lee, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter J. Lee, MD, PhD

CONTACT

617-724-4000; plee22@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: August 17, 2026
• Study Start (Estimated): December 10, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)