Prostate CancerESCAPENCT07518888
Exercise-induced Steroid Changes in Active Surveillance for Prostate Cancer
A study testing High-Intensity Interval Training (HIIT) Exercise in people with Prostate Cancer, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- High-Intensity Interval Training (HIIT) Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami Hospitals and Clinics
Miami, Florida, 33141
Elena Cortizas, MS, (305) 243-3593, ecortizas@med.miami.edu
About this study
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
- Being tested
- High-Intensity Interval Training (HIIT) Exercise
- Keywords
- Prostate Cancer, Exercise, Steroids, Active Surveillance
- Medical subject headings
- Prostatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval Training (HIIT) ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 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. Receives: Behavioral: High-Intensity Interval Training (HIIT) Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately after protocol completion (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start30 Nov 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nima Sharifi, University of Miami
- Investigators
- Nima Sharifi, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518888
- Sponsor's protocol ID
- 20251282
- Acronym
- ESCAPE
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-induced Steroid Changes in Active Surveillance for Prostate Cancer
- ClinicalTrials.gov ID
- NCT07518888
- Acronym / sponsor ID
- ESCAPE / 20251282
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Exercise, Steroids, Active Surveillance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-Based High Intensity Interval Training (HIIT) Exercise Session + Saliva Collection | Experimental | Behavioral: High-Intensity Interval Training (HIIT) ExerciseParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Interval Training (HIIT) ExerciseParticipants 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. | Behavioural | Home-Based High Intensity Interval Training (HIIT) Exercise Session + Saliva Collection |
Primary outcome
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.
1 secondary outcome
Acceptability of the Exercise and Saliva Collection Protocol
Time frame: Immediately after protocol completion (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nima Sharifi, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Training (HIIT) Exercise in people with Prostate Cancer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nima Sharifi, MD (305-243-1350, nimasharifi@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protocol Completion Rate (time frame: From enrollment through completion of all study procedures (up to Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.