Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07768917

Training on Systemic and Organ Spec. PM in PC

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location contact

Peter Lee, MD, PhD

CONTACT

[email protected]

617-724-4000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Exercise

Other

Supervised and structured strength and conditioning program

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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.

  17. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Peter J. Lee, MD, PhD

CONTACT

[email protected]

617-724-4000

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Impact of Prescribed Physical Training on Systemic and Organ Specific Prognostic Markers in Prostate Cancer

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.