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Neoadjuvant Exercise Therapy in Prostate Cancer: A Phase 1, Decentralized Nonrandomized ControlledTrial
Lee W Jones1,2, Chaya S Moskowitz1, Catherine P Lee1
1Memorial Sloan Kettering Cancer Center, New York, New York.
JAMA Oncology
|July 18, 2024
Summary
Exercise therapy is feasible and safe for localized prostate cancer patients, with 225 minutes per week recommended for Phase 2 trials. This approach shows promising tumor biological activity.
Area of Science:
- Oncology
- Exercise Physiology
- Clinical Trials
Background:
- Postdiagnosis exercise is linked to reduced prostate cancer mortality.
- The feasibility and tumor biological effects of exercise therapy remain unknown.
Purpose of the Study:
- To determine the recommended Phase 2 dose of exercise therapy for prostate cancer patients.
- To assess the feasibility and tumor biological activity of exercise interventions.
Main Methods:
- A single-center, Phase 1a dose-finding trial involving 53 men with localized prostate cancer.
- Six escalated doses of moderate-intensity treadmill walking (90-450 min/week) delivered remotely.
- Feasibility assessed by relative exercise dose intensity (REDI); tumor proliferation (Ki67) and PSA levels as activity endpoints.
Main Results:
- All tested exercise doses were feasible, with patients achieving ≥75% REDI.
- No serious adverse events were recorded.
- 225 minutes per week was identified as the recommended Phase 2 dose, showing a trend towards reduced tumor proliferation and PSA levels.
Conclusions:
- Neoadjuvant exercise therapy is a feasible and safe intervention for localized prostate cancer.
- Exercise therapy demonstrates promising tumor biological activity, warranting further investigation in Phase 2 trials.
