Exercise-induced Steroid Changes in Active Surveillance for Prostate Cancer

NCT07518888 | Not Yet Recruiting

• 1 other identifier: 20251282
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Exercise; Steroids

Outcome Measures

Primary Outcomes (1)

• Protocol Completion Rate

  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 Outcomes (1)

• Acceptability of the Exercise and Saliva Collection Protocol

  Immediately after protocol completion (Day 1)

Study Arms (1)

Home-Based High Intensity Interval Training (HIIT) Exercise Session + Saliva Collection

EXPERIMENTAL

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

Interventions

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.

Home-Based High Intensity Interval Training (HIIT) Exercise Session + Saliva Collection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Hospitals and Clinics

Miami, Florida, 33141, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Interventions

High-Intensity Interval Training; Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nima Sharifi, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nima Sharifi, MD

CONTACT

305-243-1350; nimasharifi@miami.edu

Elena Cortizas, MS

CONTACT

(305) 243-3593; ecortizas@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Scientific Director of the Desai Sethi Urology Institute

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 9, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)