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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 2

Conditions: Localized Prostate Carcinoma; Prostate Adenocarcinoma; Prostate Cancer

Treatments: Behavioral: Exercise Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05751434

22-419

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Participants Assigned to Exercise Therapy

Experimental group

Description:

Participants with histologically confirmed localized prostate cancer undergoing active surveillance

Treatment:

Behavioral: Exercise Therapy

Participants Assigned to Usual Care

No Intervention group

Description:

Participants with histologically confirmed localized prostate cancer undergoing active surveillance