Trial Title:
A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
NCT ID:
NCT05751434
Condition:
Prostate Cancer
Prostate Adenocarcinoma
Localized Prostate Carcinoma
Conditions: Official terms:
Prostatic Neoplasms
Adenocarcinoma
Conditions: Keywords:
Prostate Cancer
Prostate Adenocarcinoma
Localized Prostate Carcinoma
exercise therapy
Memorial Sloan Kettering Cancer Center
22-419
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Exercise Therapy
Description:
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).
Arm group label:
Participants Assigned to Exercise Therapy
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.
Criteria for 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 and PAR-Q)
- BMI <40 kg/m^2
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, Los Angeles (Data and Specimen Analysis Only)
Address:
City:
Los Angeles
Zip:
90095-1781
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Paul Boutros, PhD
Phone:
310-794-7160
Contact backup:
Last name:
Jaron Arbet, PhD
Facility:
Name:
Hartford Healthcare Alliance (Data collection only)
Address:
City:
Hartford
Zip:
06102
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Andrew Salner, MD
Phone:
860-972-2803
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lee Jones, PhD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lee Jones, PhD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited protocol activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lee Jones, PhD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lee Jones, PhD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited protocol activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lee Jones, PhD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lee Jones, PhD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited protocol activites)
Address:
City:
Rockville Centre
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lee Jones, PhD
Phone:
646-888-8103
Start date:
February 10, 2023
Completion date:
February 10, 2027
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05751434
http://www.mskcc.org
