A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer

Clinicaltrials.gov ID: NCT05751434
db-list-check Status RECRUITING
b-loader Phase PHASE2
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 102

Conditions

Prostate Cancer, Prostate Adenocarcinoma, Localized Prostate Carcinoma

Summary

The purpose of this study is to find out the effects of exercise therapy on indicators of prostate cancer in people with low-risk prostate cancer who are on active surveillance. The exercise therapy in this study will be regular home-based walking sessions on a treadmill, and that therapy will be assigned by an exercise physiologist (a medical professional who studies how exercise affects the human body). Some participants in this study will have the assigned exercise therapy, and some participants will participate in their usual exercise routines. Researchers will compare how the assigned exercise therapy and the usual exercise routines affect indicators of prostate cancer in participants. This study will not provide treatment for prostate cancer.

Locations

7 locations Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • Lee Jones, PhD
  • 646-888-8103

Principal Investigator

  • Lee Jones, PhD

Status

  • RECRUITING

Contact Person

  • Lee Jones, PhD
  • 646-888-8103

Principal Investigator

  • Lee Jones, PhD

Status

  • RECRUITING

Contact Person

  • Lee Jones, PhD
  • 646-888-8103

Principal Investigator

  • Lee Jones, PhD

Status

  • RECRUITING

Contact Person

  • Lee Jones, PhD
  • 646-888-8103

Principal Investigator

  • Lee Jones, PhD

Status

  • RECRUITING

Contact Person

  • Lee Jones, PhD
  • 646-888-8103

Principal Investigator

  • Lee Jones, PhD

Status

  • RECRUITING

Contact Person

  • Lee Jones, PhD
  • 646-888-8103

Principal Investigator

  • Lee Jones, PhD

Status

  • RECRUITING

Contact Person

  • Lee Jones, PhD
  • 646-888-8103

Principal Investigator

  • Lee Jones, PhD

Eligibility Criteria

Inclusion Criteria:

* Age ≥ 18
* Men with histologically confirmed localized prostate cancer undergoing active surveillance.
* Inactive, defined as not meeting the national exercise guidelines for cancer patients (<150 minutes/week of moderate or vigorous exercise)43 as assessed by remote activity and heart rate tracking for a 7-day period prior to study entry (general physical activity screening assessment via smart watch).
* Screening clearance by an MSK Exercise Physiologist (i.e., review of ECG and PAR-Q)
* BMI <40 kg/m^2

Exclusion Criteria:

* Enrollment in any other program that may alter the impact of exercise on tumor outcomes (e.g., weight loss program)
* Any neoadjuvant anticancer treatment of any kind for prostate cancer in the last 5 years
* Any history of systemic anticancer therapy in the last 15 years
* Distant metastatic malignancy of any kind
* Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation

Study Plan

Participants Assigned to Exercise Therapy

EXPERIMENTAL

Participants with histologically confirmed localized prostate cancer undergoing active surveillance

  • BEHAVIORAL:

    Exercise Therapy

    Description:

    The intervention will consist of exercise therapy, individualized, walking delivered following a non-linear (i.e., exercise dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule, up to 5 individual treatment sessions/week to achieve a cumulative total duration of 225 to 300 mins/wk until the participant's next standard of care prostate biopsy (about 6-12 months).

Participants Assigned to Usual Care

NO_INTERVENTION

Participants with histologically confirmed localized prostate cancer undergoing active surveillance

    Outcome Measures

    Primary Outcome Measures

    Change in molecular, radiologic, and pathologic nimbosus hallmarks from baseline to follow-up

    Time Frame: 6-12 months

    Timeline

    • Last Updated
      November 8, 2024
    • Start Date
      March 2, 2023
    • Today
      February 5, 2025
    • Completion Date ( Estimated )
      February 10, 2027

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