Phase 2 Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- Exercise Therapy
- Conditions
- Prostate Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 36
- Locations
- 9
- Primary Endpoint
- Change in molecular, radiologic, and pathologic nimbosus hallmarks from baseline to follow-up
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Arms & Interventions
Participants Assigned to Exercise Therapy
Participants with histologically confirmed localized prostate cancer undergoing active surveillance
Intervention: Exercise Therapy
Participants Assigned to Usual Care
Participants with histologically confirmed localized prostate cancer undergoing active surveillance
Outcomes
Primary Outcomes
Change in molecular, radiologic, and pathologic nimbosus hallmarks from baseline to follow-up
Time Frame: 6-12 months
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.