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:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer Prostate Adenocarcinoma Localized Prostate Carcinoma | Behavioral: Exercise Therapy | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 102 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase 2 Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer |
| Actual Study Start Date : | February 10, 2023 |
| Estimated Primary Completion Date : | February 10, 2027 |
| Estimated Study Completion Date : | February 10, 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Prostate cancer
| 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
|
Primary Outcome Measures :
- 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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| 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 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05751434
Contacts
| Contact: Lee Jones, PhD | 646-888-8103 | jonesl3@mskcc.org | |
| Contact: Behfar Ehdaie, MD, MPH | 646-422-4406 | EhdaieB@mskcc.org |
Locations
| United States, California | |
| University of California, Los Angeles (Data and Specimen Analysis Only) | Not yet recruiting |
| Los Angeles, California, United States, 90095-1781 | |
| Contact: Paul Boutros, PhD 310-794-7160 | |
| 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: Lee Jones, PhD 646-888-8103 | |
| Memorial Sloan Kettering Monmouth (Limited protocol activities) | Recruiting |
| Middletown, New Jersey, United States, 07748 | |
| Contact: Lee Jones, PhD 646-888-8103 | |
| Memorial Sloan Kettering Bergen (Limited protocol activities) | Recruiting |
| Montvale, New Jersey, United States, 07645 | |
| 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: Lee Jones, PhD 646-888-8103 | |
| Memorial Sloan Kettering Westchester (Limited protocol activities) | Recruiting |
| Harrison, New York, United States, 10604 | |
| Contact: Lee Jones, PhD 646-888-8103 | |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Lee Jones, PhD 646-888-8103 | |
| Memorial Sloan Kettering Nassau (Limited protocol activites) | Recruiting |
| Rockville Centre, New York, United States, 11553 | |
| Contact: Lee Jones, PhD 646-888-8103 | |
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
| Principal Investigator: | Lee Jones, PhD | Memorial Sloan Kettering Cancer Center |
Additional Information:
| Responsible Party: | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT05751434 |
| Other Study ID Numbers: |
22-419 |
| First Posted: | March 2, 2023 Key Record Dates |
| Last Update Posted: | January 10, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Memorial Sloan Kettering Cancer Center:
|
Prostate Cancer Prostate Adenocarcinoma Localized Prostate Carcinoma |
exercise therapy Memorial Sloan Kettering Cancer Center 22-419 |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Genital Neoplasms, Male |
Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases |