Clinical trial NCT05751434: A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
Official title: Phase 2 Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Localized Prostate Carcinoma
Keywords: Prostate Cancer
Prostate Adenocarcinoma
Localized Prostate Carcinoma
exercise therapy
Memorial Sloan Kettering Cancer Center
22-419
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 102
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in molecular, radiologic, and pathologic nimbosus hallmarks from baseline to follow-up
timeFrame: 6-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles (Data and Specimen Analysis Only)
state: California
city: Hartford
country: United States
facility: Hartford Healthcare Alliance (Data collection only)
state: Connecticut
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited protocol activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited protocol activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Limited protocol activites)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Lee Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: