A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Participants Assigned to Exercise Therapy Participants with histologically confirmed localized prostate cancer undergoing active surveillance |
Behavioral: 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).
|
| No Intervention: Participants Assigned to Usual Care Participants with histologically confirmed localized prostate cancer undergoing active surveillance |
Outcome Measures
Primary Outcome Measures
- Change in Nimbosus hallmarks evaluation from baseline to 6 months [6 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 (confirmatory biopsy), as per standard procedures.
- Change in Nimbosus hallmarks evaluation from baseline to 12 months [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 12 (confirmatory biopsy), as per standard procedures.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18
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Men with histologically confirmed localized prostate cancer undergoing active surveillance.
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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).
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Screening clearance by an MSK Exercise Physiologist (i.e., review of ECG and PAR-Q)
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BMI <40 kg/m^2
Exclusion Criteria:
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Enrollment in any other program that may alter the impact of exercise on tumor outcomes (e.g., weight loss program)
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Any neoadjuvant anticancer treatment of any kind for prostate cancer
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Any history of systemic anticancer therapy
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Distant metastatic malignancy of any kind
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Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, Los Angeles | Los Angeles | California | United States | 90095-1781 |
| 2 | Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Basking Ridge | New Jersey | United States | 07920 |
| 3 | Memorial Sloan Kettering Monmouth (Limited protocol activities) | Middletown | New Jersey | United States | 07748 |
| 4 | Memorial Sloan Kettering Bergen (Limited protocol activities) | Montvale | New Jersey | United States | 07645 |
| 5 | Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities) | Commack | New York | United States | 11725 |
| 6 | Memorial Sloan Kettering Westchester (Limited protocol activities) | Harrison | New York | United States | 10604 |
| 7 | Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | United States | 10065 |
| 8 | Memorial Sloan Kettering Nassau (Limited protocol activites) | Rockville Centre | New York | United States | 11553 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
Investigators
- Principal Investigator: Lee Jones, PhD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 22-419