RecruitingRecruiting
A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
NCT05751434 · City of Hope Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Phase 2 Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer
About this study
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.
Eligibility 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
Study design
Enrollment target: 102 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-02-10
Estimated completion: 2028-06-01
Last updated: 2026-07-30
Interventions
Behavioral: Exercise Therapy
Primary outcomes
- • Change in molecular, radiologic, and pathologic nimbosus hallmarks from baseline to follow-up (6-12 months)
Sponsor
City of Hope Medical Center · other
Contacts & investigators
ContactLee Jones · contact · leejones@coh.org · 6262184673
InvestigatorLee Jones · principal_investigator, City of Hope Medical Center
All locations (10)
City of Hope Medical CenterRecruiting
Durate, California, United States
University of California, Los Angeles (Data and Specimen Analysis Only)Not Yet Recruiting
Los Angeles, California, United States
Hartford Healthcare Alliance (Data collection only)Not Yet Recruiting
Hartford, Connecticut, United States
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Not Yet Recruiting
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)Not Yet Recruiting
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited protocol activities)Not Yet Recruiting
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)Not Yet Recruiting
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited protocol activities)Not Yet Recruiting
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)Not Yet Recruiting
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited protocol activites)Not Yet Recruiting
Rockville Centre, New York, United States