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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Prostate Adenocarcinoma; Localized Prostate Carcinoma
• Intervention / Treatment: Behavioral: Exercise Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lee Jones; Phone Number: 6262184673; Email: leejones@coh.org

Study Locations

• United States
  • California
    • Durate, California, United States, 91010
      • Recruiting
      • City of Hope Medical Center
      • Contact: Lee Jones; Phone Number: 6262184673; Email: leejones@coh.org
    • Los Angeles, California, United States, 90095-1781
      • Not yet recruiting
      • University of California, Los Angeles (Data and Specimen Analysis Only)
      • Contact: Paul Boutros, PhD; Phone Number: 310-794-7160
      • Contact: Jaron Arbet, PhD
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Not yet recruiting
      • Hartford Healthcare Alliance (Data Collection Only)
      • Contact: Andrew Salner, MD; Phone Number: (860) 972-2803
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Not yet recruiting
      • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
      • Contact: Jessica Scott, PhD; Phone Number: 646-888-8093
    • Middletown, New Jersey, United States, 07748
      • Not yet recruiting
      • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
      • Contact: Jessica Scott, PhD; Phone Number: 646-888-8093
    • Montvale, New Jersey, United States, 07645
      • Not yet recruiting
      • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
      • Contact: Jessica Scott, PhD; Phone Number: 646-888-8093
  • New York
    • Commack, New York, United States, 11725
      • Not yet recruiting
      • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
      • Contact: Jessica Scott, PhD; Phone Number: 646-888-8093
    • Harrison, New York, United States, 10604
      • Not yet recruiting
      • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
      • Contact: Jessica Scott, PhD; Phone Number: 646-888-8093
    • New York, New York, United States, 10065
      • Not yet recruiting
      • Memorial Sloan Kettering Cancer Center (All protocol activities)
      • Contact: Jessica Scott, PhD; Phone Number: 646-888-8093
    • Rockville Centre, New York, United States, 11553
      • Not yet recruiting
      • Memorial Sloan Kettering Nassau (Limited Protocol Activites)
      • Contact: Jessica Scott, PhD; Phone Number: 646-888-8093

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants Assigned to Exercise Therapy; Participants with histologically confirmed localized prostate cancer undergoing active surveillance	Behavioral: Exercise Therapy; 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).
No Intervention: Participants Assigned to Usual Care; Participants with histologically confirmed localized prostate cancer undergoing active surveillance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Investigators: Principal Investigator: Lee Jones, City of Hope Medical Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): July 30, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Prostate Cancer; Prostate Adenocarcinoma; exercise therapy; Localized Prostate Carcinoma
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Therapeutics; Physical Therapy Modalities; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Exercise Therapy
• Other Study ID Numbers: 25780

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No