Back to resultsA Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
Primary Purpose
Prostate Cancer, Prostate Adenocarcinoma, Localized Prostate Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exercise Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Prostate Adenocarcinoma, Localized Prostate Carcinoma, exercise therapy, Memorial Sloan Kettering Cancer Center, 22-419
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
Sites / Locations
- University of California, Los Angeles (Data and Specimen Analysis Only)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Monmouth (Limited protocol activities)Recruiting
- Memorial Sloan Kettering Bergen (Limited protocol activities)Recruiting
- Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)Recruiting
- Memorial Sloan Kettering Westchester (Limited protocol activities)Recruiting
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Nassau (Limited protocol activites)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Participants Assigned to Exercise Therapy
Participants Assigned to Usual Care
Arm Description
Participants with histologically confirmed localized prostate cancer undergoing active surveillance
Participants with histologically confirmed localized prostate cancer undergoing active surveillance
Outcomes
Primary Outcome Measures
Change in molecular, radiologic, and pathologic nimbosus hallmarks from baseline to follow-up
The phenomenon of multiple independent prognostic features that moderately correlate with one another has been termed Nimbosus, "a gathering of storm clouds". The more Nimbosus hallmarks present in a tumor, the more aggressive it is likely to be, and the greater the chance that it will escape the prostate leading to nodal and distal metastatic spread. Nimbosus hallmarks provides a targetable set of biomarkers to test in a RCT of exercise therapy in localized prostate cancer.
Molecular end points will be evaluated on FFPE tumor samples obtained from a total of two ultrasound-guided transrectal prostate biopsies performed at pretreatment (diagnostic biopsy) and post-intervention around month 6-12 (confirmatory biopsy), as per standard procedures.
Secondary Outcome Measures
Full Information
NCT ID
NCT05751434
First Posted
February 10, 2023
Last Updated
July 26, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05751434
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
February 10, 2027 (Anticipated)
Study Completion Date
February 10, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Adenocarcinoma, Localized Prostate Carcinoma
Keywords
Prostate Cancer, Prostate Adenocarcinoma, Localized Prostate Carcinoma, exercise therapy, Memorial Sloan Kettering Cancer Center, 22-419
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants Assigned to Exercise Therapy
Arm Type
Experimental
Arm Description
Participants with histologically confirmed localized prostate cancer undergoing active surveillance
Arm Title
Participants Assigned to Usual Care
Arm Type
No Intervention
Arm Description
Participants with histologically confirmed localized prostate cancer undergoing active surveillance
Intervention Type
Behavioral
Intervention Name(s)
Exercise Therapy
Intervention 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).
Primary Outcome Measure Information:
Title
Change in molecular, radiologic, and pathologic nimbosus hallmarks from baseline to follow-up
Description
The phenomenon of multiple independent prognostic features that moderately correlate with one another has been termed Nimbosus, "a gathering of storm clouds". The more Nimbosus hallmarks present in a tumor, the more aggressive it is likely to be, and the greater the chance that it will escape the prostate leading to nodal and distal metastatic spread. Nimbosus hallmarks provides a targetable set of biomarkers to test in a RCT of exercise therapy in localized prostate cancer.
Molecular end points will be evaluated on FFPE tumor samples obtained from a total of two ultrasound-guided transrectal prostate biopsies performed at pretreatment (diagnostic biopsy) and post-intervention around month 6-12 (confirmatory biopsy), as per standard procedures.
Time Frame
6-12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lee Jones, PhD
Phone
646-888-8103
Email
jonesl3@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Behfar Ehdaie, MD, MPH
Phone
646-422-4406
Email
EhdaieB@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles (Data and Specimen Analysis Only)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Boutros, PhD
Phone
310-794-7160
First Name & Middle Initial & Last Name & Degree
Jaron Arbet, PhD
Facility Name
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Phone
646-888-8103
Facility Name
Memorial Sloan Kettering Monmouth (Limited protocol activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Phone
646-888-8103
Facility Name
Memorial Sloan Kettering Bergen (Limited protocol activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Phone
646-888-8103
Facility Name
Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Phone
646-888-8103
Facility Name
Memorial Sloan Kettering Westchester (Limited protocol activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Phone
646-888-8103
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Phone
646-888-8103
Facility Name
Memorial Sloan Kettering Nassau (Limited protocol activites)
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Phone
646-888-8103
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
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