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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-10

Study Completion Date

2027-02-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer Prostate Adenocarcinoma Localized Prostate Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants Assigned to Exercise Therapy

Participants with histologically confirmed localized prostate cancer undergoing active surveillance

Group Type EXPERIMENTAL

Exercise Therapy

Intervention Type BEHAVIORAL

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

Participants with histologically confirmed localized prostate cancer undergoing active surveillance

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise Therapy

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
* BMI \<40 kg/m\^2
* Cleared for exercise participation as per pre-screening clearance via the Physical Activity Readiness Questionnaire (PAR-Q+) (Appendix B)

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No