Actively Recruiting
Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound
Led by Case Comprehensive Cancer Center · Updated on 2026-05-07
276
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to compare the novel single-port robotic partial prostatectomy to High-intensity focused ultrasound (HIFU) in patients with low to intermediate risk localized prostate cancer. These interventions have become acceptable focal therapies prevalent with beneficial oncologic outcomes and therefore need to be examined further.
CONDITIONS
Official Title
Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-confirmed prostate cancer, stage T1a, T2a, T2b, or T2c by MRI staging
- MRI region of interest (ROI) PIRADs grade 3 or greater
- Serum PSA 10 ng/ml or less
- MRI includes T2-weighted, diffusion, and dynamic contrast-enhanced sequences with specified technical details
- Clinically significant prostate cancer defined as Gleason score 3+4 or less in any core
- Preoperative biopsy includes at least 12 randomized samples and two targeted samples per MRI target
- Life expectancy greater than 10 years
- Age over 18 years
- Ability and willingness to sign informed consent
You will not qualify if you...
- Prior extensive pelvic surgery, pelvic fractures, hemorrhoid or fissure surgery, cardiac pacemaker, or metal prosthesis
- Previous prostate cancer treatment such as radiotherapy, focal, or hormonal therapy
- Uncorrected coagulopathy or history of latex allergy
- Active soft tissue or urinary infection, indwelling Foley catheter, or severe urinary symptoms
- Poor surgical risk (ASA score greater than 3)
- Conditions or history that may confound study results or increase risk (e.g., significant cardiovascular disease, chronic opiate use, pain syndrome, drug abuse)
- Prostate size larger than 80 grams
- Prostatic calcification greater than 0.5 cc near treatment area
- Extraprostatic extension or cribriform pattern on biopsy
- Sexual dysfunction defined as SHIM score less than 17
- Uncontrolled intercurrent illness including infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Glickman Urological & Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
J
Jihad Kaouk, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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