A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
Phase 2 Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer
1 other identifier
interventional
102
1 country
10
Brief Summary
To determine the effects of exercise therapy on molecular, radiologic, and pathologic nimbosus hallmarks versus usual care control in men on Active Surveillance for localized prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Feb 2023
Typical duration for phase_2 prostate-cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2023
CompletedStudy Start
First participant enrolled
February 10, 2023
CompletedFirst Posted
Study publicly available on registry
March 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
July 30, 2026
July 1, 2026
5.1 years
February 10, 2023
July 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6-12 months
Study Arms (2)
Participants Assigned to Exercise Therapy
EXPERIMENTALParticipants with histologically confirmed localized prostate cancer undergoing active surveillance
Participants Assigned to Usual Care
NO INTERVENTIONParticipants with histologically confirmed localized prostate cancer undergoing active surveillance
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
City of Hope Medical Center
Durate, California, 91010, United States
University of California, Los Angeles (Data and Specimen Analysis Only)
Los Angeles, California, 90095-1781, United States
Hartford Healthcare Alliance (Data collection only)
Hartford, Connecticut, 06102, United States
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited protocol activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited protocol activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited protocol activites)
Rockville Centre, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lee Jones
City of Hope Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2023
First Posted
March 2, 2023
Study Start
February 10, 2023
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
July 30, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
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.