ClinicalTrials.gg
RecruitingNCT07518888ESCAPEUpdated Oct 23, 2026

Exercise-induced Steroid Changes in Active Surveillance for Prostate Cancer

An interventional study of High-Intensity Interval Training (HIIT) Exercise in Prostate Cancer, sponsored by University of Miami. Recruiting at 1 site in United States. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by University of Miami · Not applicable, Interventional, and Basic science

Updated Oct 23, 2026Now RecruitingSite recruiting status changed+4 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostate Cancer

Keywords

  • Prostate Cancer
  • Exercise
  • Steroids
  • Active Surveillance
03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.

Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Males currently receiving treatment for prostate cancer
  • Diagnosis of 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 metabolism
  • Unable to sign consent and/or comply with study requirements
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • 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 performed at a moderate-to-high intensity lasting approximately 20 minutes. Saliva samples will be collected immediately prior to exercise, immediately following exercise (0-5 minutes), and 15-20 minutes post-exercise.

    Behavioral: High-Intensity Interval Training (HIIT) Exercise

Interventions

  • BehavioralHigh-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 3 rounds of moderate to high intensity bodyweight exercises, including movements such as hip thrusts, lateral squats, wall pushups, lat pull downs, lunges, and jumping jacks.

06

What researchers measure

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.

    Time frame: From enrollment through completion of all study procedures (up to Day 1)

Secondary outcomes

  1. Acceptability of the Exercise and Saliva Collection Protocol

    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.

    Time frame: Immediately after protocol completion (Day 1)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 23, 2026
Sites
University of Miami Hospitals and Clinics is now Recruiting
Oct 23, 2026
Start date
Oct 2026→Nov 30, 2026
Oct 23, 2026
Primary completion
Aug 2027→Feb 2028
Oct 23, 2026
Study completion
Aug 2028→Feb 2029
Oct 23, 2026
Enrollment
49→50
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    Not yet recruiting→Recruiting
    University of Miami Hospitals and Clinics is now Recruiting
    Start date Oct 2026→Nov 30, 2026
    Primary completion Aug 2027→Feb 2028
    Study completion Aug 2028→Feb 2029
    Enrollment 49→50
    + 3 other changes: verification date, conditions and arm descriptions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07518888
Responsible party
Nima Sharifi (Professor and Scientific Director of the Desai Sethi Urology Institute, University of Miami) — Principal investigator
First posted
Apr 9, 2026
Start date
Nov 30, 2026 (estimated)
Primary completion
Feb 2028 (estimated)
Completion
Feb 2029 (estimated)
Last update
Oct 23, 2026

Study contacts

Nima Sharifi, MD
Contact
nimasharifi@miami.edu
305-243-1350
Elena Cortizas, MS
Contact
ecortizas@med.miami.edu
(305) 243-3593
Nima Sharifi, MD
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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