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

Study Overview
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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.

Official Title
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Phase 2 Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer

Conditions
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Prostate Cancer, Prostate Adenocarcinoma, Localized Prostate Carcinoma

Intervention / Treatment
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* Behavioral: Exercise Therapy


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants Assigned to Exercise Therapy<br>Participants with histologically confirmed localized prostate cancer undergoing active surveillance | Behavioral: Exercise Therapy<br>* 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).<br>|
| No Intervention: Participants Assigned to Usual Care<br>Participants with histologically confirmed localized prostate cancer undergoing active surveillance | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in molecular, radiologic, and pathologic nimbosus hallmarks from baseline to follow-up | The phenomenon of multiple independent prognostic features that moderately correlate with one another has been termed Nimbosus, a gathering of storm clouds. The more Nimbosus hallmarks present in a tumor, the more aggressive it is likely to be, and the greater the chance that it will escape the prostate leading to nodal and distal metastatic spread. Nimbosus hallmarks provides a targetable set of biomarkers to test in a RCT of exercise therapy in localized prostate cancer. Molecular end points will be evaluated on FFPE tumor samples obtained from a total of two ultrasound-guided transrectal prostate biopsies performed at pretreatment (diagnostic biopsy) and post-intervention around month 6-12 (confirmatory biopsy), as per standard procedures. | 6-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Prostate Adenocarcinoma, Localized Prostate Carcinoma, exercise therapy, Memorial Sloan Kettering Cancer Center, 22-419