Exercise-induced Steroid Changes in Active Surveillance for Prostate Cancer (ESCAPE)

April 1, 2026 updated by: Nima Sharifi, University of Miami
The purpose of this research study is to understand how a short session of a home-based bodyweight high-intensity interval training (HIIT) affects steroid hormone levels in men on active surveillance for low-grade prostate cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33141
        • University Of Miami Hospitals And Clinics
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males 18 to 80 years old
  • Diagnosis of localized prostate cancer
  • Currently under active surveillance
  • Ability to perform moderate-to-high intensity physical activity as demonstrated by self-assessment using the Physical Activity Readiness Questionnaire (PAR-Q+)
  • Able to independently perform activities of daily living, without limitations in mobility
  • Ability to read, write, speak, and understand English
  • Able and willing to sign consent and comply with study requirements

Exclusion Criteria:

  • Males currently receiving treatment for prostate cancer
  • Diagnosis of metastatic prostate cancer
  • Individuals with medical conditions contraindicating exercise
  • Uncontrolled cardiovascular or circulatory diseases, hypertension, and diabetes, as determined by the study doctor or treating physician
  • Ongoing use of medications affecting steroid metabolism
  • Unable to sign consent and/or comply with study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home-Based High Intensity Interval Training (HIIT) Exercise Session + Saliva Collection
Participants will complete a single supervised, online high intensity interval training (HIIT) exercise session with six bouts of 1-minute exercises performed at a moderate-to-high intensity lasting approximately 20 minutes. Saliva samples will be collected immediately prior to exercise, immediately following exercise, and 15 minutes post-exercise.
Behavioral: High-Intensity Interval Training (HIIT) Exercise
Participants will complete a single supervised, online high intensity interval training (HIIT) exercise session lasting approximately 20 minutes. The exercise protocol consists of six 1-minute bouts with 1-minute rest intervals of moderate to high intensity bodyweight exercises, including movements such as lateral squats, wall pushups, and chair assisted sit to stands.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protocol Completion Rate
Time Frame: From enrollment through completion of all study procedures (up to Day 1)
Protocol Completion Rate is defined as the proportion of enrolled participants who complete both the supervised home-based HIIT exercise session and return all scheduled saliva samples to the laboratory.
From enrollment through completion of all study procedures (up to Day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of the Exercise and Saliva Collection Protocol
Time Frame: Immediately after protocol completion (Day 1)
Acceptability will be assessed using a participant-reported questionnaire adapted from the Theoretical Framework of Acceptability (TFA). The questionnaire evaluates acceptability across seven domains: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy. Each domain is assessed using 1-2 items rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Domain scores are averaged, and an overall Acceptability Index score is calculated, with higher scores indicating greater acceptability.
Immediately after protocol completion (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Nima Sharifi, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20251282

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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