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

Prostate Cancer Clinical Trial

Official title:

Phase 2 Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05751434
• Other study ID #: 22-419
• Status: Recruiting
• Phase: Phase 2
• Start date: February 10, 2023
• Est. completion date: February 10, 2027

Study information

• Verified date: January 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Lee Jones, PhD
• Phone: 646-888-8103
• Email: jonesl3[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: February 10, 2027
• Est. primary completion date: February 10, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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).

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Limited protocol activities)	Harrison	New York
United States	University of California, Los Angeles (Data and Specimen Analysis Only)	Los Angeles	California
United States	Memorial Sloan Kettering Monmouth (Limited protocol activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited protocol activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited protocol activites)	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center