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NCT Number: NCT05751434

A Study on the Effects of Exercise Therapy on Signs of 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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

City of Hope Medical Center, Durate, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Therapy

Behavioral

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).

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lee Jones

CONTACT

[email protected]

6262184673

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Mar 2, 2023
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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