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NCT Number: NCT07518888

Exercise-induced Steroid Changes in Active Surveillance for Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Behavior Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

High-Intensity Interval Training (HIIT) Exercise

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

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

Elena Cortizas, MS

CONTACT

[email protected]

(305) 243-3593

Nima Sharifi, MD

CONTACT

[email protected]

305-243-1350

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Acronym: ESCAPE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 9, 2026
Registry last updated
Jul 17, 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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