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History of Changes for Study: NCT05751434
A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
Latest version (submitted January 9, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 20, 2023 None (earliest Version on record)
2 March 15, 2023 Outcome Measures, Contacts/Locations and Study Status
3 April 24, 2023 Study Status
4 July 11, 2023 Study Status
5 July 26, 2023 Eligibility and Study Status
6 January 9, 2024 Study Status
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Study NCT05751434
Submitted Date:  February 20, 2023 (v1)
Open or close this module Study Identification
Unique Protocol ID: 22-419
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
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2023
Overall Status: Recruiting
Study Start: February 10, 2023
Primary Completion: February 10, 2027 [Anticipated]
Study Completion: February 10, 2027 [Anticipated]
First Submitted: February 10, 2023
First Submitted that
Met QC Criteria:		 February 20, 2023
First Posted: March 2, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:		 February 20, 2023
Last Update Posted: March 2, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Memorial Sloan Kettering Cancer Center
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
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
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 102 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change in Nimbosus hallmarks evaluation from baseline to 6 months
[ Time Frame: 6 months ]

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 (confirmatory biopsy), as per standard procedures.
2. Change in Nimbosus hallmarks evaluation from baseline to 12 months
[ Time Frame: 12 months ]

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 12 (confirmatory biopsy), as per standard procedures.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Male
Gender Based:
Accepts Healthy Volunteers: No
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
  • Any history of systemic anticancer therapy
  • 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
Open or close this module Contacts/Locations
Central Contact Person: Lee Jones, PhD
Telephone: 646-888-8103
Email: jonesl3@mskcc.org
Central Contact Backup: Behfar Ehdaie, MD, PhD
Telephone: 646-422-4406
Email: EhdaieB@mskcc.org
Study Officials: Lee Jones, PhD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Locations: United States, California
University of California, Los Angeles
[Not yet recruiting]
Los Angeles, California, United States, 90095-1781
Contact:Contact: Paul Boutros, PhD 310-794-7160
Contact:Contact: Jaron Arbet, PhD
United States, New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
[Recruiting]
Basking Ridge, New Jersey, United States, 07920
Contact:Contact: Lee Jones, PhD 646-888-8103
Memorial Sloan Kettering Monmouth (Limited protocol activities)
[Recruiting]
Middletown, New Jersey, United States, 07748
Contact:Contact: Lee Jones, PhD 646-888-8103
Memorial Sloan Kettering Bergen (Limited protocol activities)
[Recruiting]
Montvale, New Jersey, United States, 07645
Contact:Contact: Lee Jones, PhD 646-888-8103
United States, New York
Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)
[Recruiting]
Commack, New York, United States, 11725
Contact:Contact: Lee Jones, PhD 646-888-8103
Memorial Sloan Kettering Westchester (Limited protocol activities)
[Recruiting]
Harrison, New York, United States, 10604
Contact:Contact: Lee Jones, PhD 646-888-8103
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
[Recruiting]
New York, New York, United States, 10065
Contact:Contact: Lee Jones, PhD 646-888-8103
Memorial Sloan Kettering Nassau (Limited protocol activites)
[Recruiting]
Rockville Centre, New York, United States, 11553
Contact:Contact: Lee Jones, PhD 646-888-8103
Open or close this module IPDSharing
Plan to Share IPD: Yes
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.
Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Citations:
Links: Description: Memorial Sloan Kettering Cancer Center
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services