Recruiting
Phase 2

Exercise Therapy

Sponsor:

City of Hope Medical Center

Code:

NCT05751434

Conditions

Prostate Cancer

Prostate Adenocarcinoma

Localized Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise Therapy

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Prostate Adenocarcinoma

Localized Prostate Carcinoma

Study ID

NCT05751434

Start date

Feb 10, 2023

Status verified date

Jul, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

102 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants Assigned to Exercise Therapy

Participants with histologically confirmed localized prostate cancer undergoing active surveillance

no intervention: Participants Assigned to Usual Care

Participants with histologically confirmed localized prostate cancer undergoing active surveillance

Interventions

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).

Primary outcome measure

  • Change in molecular, radiologic, and pathologic nimbosus hallmarks from baseline to follow-up [ Time Frame: 6-12 months ]

Central Contacts and Locations

Central contacts

Lee Jones

6262184673leejones@coh.org

Locations

City of Hope Medical Center

Recruiting

Durate, California, United States, 91010

Contacts

Lee Jones

6262184673leejones@coh.org

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • Prostate Cancer
  • Prostate Adenocarcinoma
  • Localized Prostate Carcinoma
  • exercise therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-07-30.