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A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05751434
Recruitment Status : Recruiting
First Posted : March 2, 2023
Last Update Posted : January 10, 2024
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE February 10, 2023
First Posted Date  ICMJE March 2, 2023
Last Update Posted Date January 10, 2024
Actual Study Start Date  ICMJE February 10, 2023
Estimated Primary Completion Date February 10, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2023)		 Change in molecular, radiologic, and pathologic nimbosus hallmarks from baseline to follow-up [ Time Frame: 6-12 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 6-12 (confirmatory biopsy), as per standard procedures.
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2023)
  • 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.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
Official Title  ICMJE Phase 2 Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer
  • Prostate Adenocarcinoma
  • Localized Prostate Carcinoma
Intervention  ICMJE 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).
Study Arms  ICMJE
  • Experimental: Participants Assigned to Exercise Therapy
    Participants with histologically confirmed localized prostate cancer undergoing active surveillance
    Intervention: Behavioral: Exercise Therapy
  • No Intervention: Participants Assigned to Usual Care
    Participants with histologically confirmed localized prostate cancer undergoing active surveillance
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 20, 2023)		 102
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 10, 2027
Estimated Primary Completion Date February 10, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lee Jones, PhD 646-888-8103 jonesl3@mskcc.org
Contact: Behfar Ehdaie, MD, MPH 646-422-4406 EhdaieB@mskcc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05751434
Other Study ID Numbers  ICMJE 22-419
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Current Responsible Party Memorial Sloan Kettering Cancer Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lee Jones, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date January 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP