Effects of exercise therapy on prostate cancer indicators
Phase 2 Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer
This study is testing if a home-based walking program can help men with low-risk prostate cancer show better signs of their condition compared to those who stick to their usual exercise routines.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 9 sites (Los Angeles, California and 8 other locations) |
| Trial ID | NCT05751434 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of exercise therapy on signs of prostate cancer in men with low-risk localized prostate cancer who are undergoing active surveillance. Participants will be assigned to either a structured home-based walking program or continue their usual exercise routines. The exercise therapy will be supervised by an exercise physiologist, and the outcomes will be compared to assess the effectiveness of the intervention. The study aims to provide insights into how exercise may influence cancer indicators without providing direct treatment for the disease.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with histologically confirmed localized prostate cancer who are inactive and undergoing active surveillance.
Not a fit: Patients who are currently enrolled in other programs that may affect exercise outcomes or those with a history of systemic anticancer therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could demonstrate that exercise therapy may positively influence cancer indicators in patients with localized prostate cancer.
How similar studies have performed: Other studies have shown promising results regarding the benefits of exercise in cancer care, suggesting that this approach may be effective, though this specific intervention is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California and 8 other locations
- University of California, Los Angeles (Data and Specimen Analysis Only) — Los Angeles, California, United States (Not_yet_recruiting)
- Hartford Healthcare Alliance (Data collection only) — Hartford, Connecticut, United States (Recruiting)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited protocol activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited protocol activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited protocol activites) — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Lee Jones, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Lee Jones, PhD
- Email: jonesl3@mskcc.org
- Phone: 646-888-8103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.