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Comparing Robotic Partial Prostatectomy and HIFU for Prostate Cancer

This study is comparing two treatments for prostate cancer: Transvesical Single Port Robotic Partial Prostatectomy and High-intensity focused ultrasound (HIFU). Both are ways to treat localized prostate cancer that hasn't spread. The study is looking at how well these treatments prevent the cancer from coming back over one, two, and three years. You might be able to join if you are a man aged 19 or older with biopsy-confirmed prostate cancer (stages T1a, T2a, T2b, or T2c), a PSA (Prostate-Specific Antigen) level of 10 ng/ml or less, and a specific grade of cancer seen on an MRI. The study aims to enroll 276 participants. The current status of the study is unclear.

Study design
This interventional study plans to enroll 276 men. It compares two different procedures for treating prostate cancer.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for recurrence-free survival for at least three years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05610852

Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound

Recruiting
NAAges 19+InterventionalTreatment
Case Comprehensive Cancer Center
~276 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Transvesical Single Port Robotic Partial ProstatectomyHigh-intensity focused ultrasound (HIFU)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence free survival Recurrence free survival
Measured over 1 year after treatment
+2 more outcomes measured

Conditions

Prostate Adenocarcinoma
Prostate Cancer

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Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Jihad Kaouk, MD · PRINCIPAL_INVESTIGATOR · Glickman Urological & Kidney Institute: Professor of Urology

Who to contact

Jihad Kaouk, MD
[email protected]
216-444-2976
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Subjects must have histologically or cytologically: Biopsy-confirmed prostate cancer, stage T1a, T2a, T2b, or T2c prostate cancer using MRI staging, with a region of interest (ROI) PIRADs grade 3 or greater, Serum PSA 10 ng/ml or less, Region of interest on MRI of grade 3 or greater
The MRI performed must include at least:
A T2-weighted sequence in sections ≤ 4 mm, centered on the prostate and seminal vesicles, at least in the axial plane. Alternatively, a 3D T2-weighted sequence can be realized,
A diffusion sequence of ≤ 4 mm slice in the axial plane. An ADC card will be provided and calculated from at least two values of b, the maximum value of b being ≥ 600 s / mm2,
A dynamic sequence after gadolinium injection. It will be a sequence of echo T1-weighted gradient of slice ≤ 4 mm, centered on the prostate and seminal vesicles in the axial plane, with or without fat saturation. A first series will be performed without contrast injection, and will be repeated iteratively for the arrival of a bolus of gadolinium chelates. The time resolution (that is to say, the acquisition time of one dynamic series will be ≤ 20 seconds). The number of chained dynamic series is calculated so that the total length of the dynamic acquisition be at least 3 minutes
A total dose of 0.1 mmol / kg of gadolinium chelate will be injected at a rate of 3-4 mL / s by using an automatic injector, in a vein of the hand of the forearm or elbow.
If necessary, subtracted images are calculated
Clinically significant prostate cancer defined as Gleason score 3+4 or less in any core
Biopsies for preoperative diagnosis of prostate cancer will have included: At least 12 randomized samples (2 samples per sextant), At least two targeted sampling on each target score MRI ESUR ≥ 3/5
Life expectancy greater than 10 years.
Age \>18 years.
Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion

Patients with any prior extensive pelvic surgery, pelvic fractures, hemorrhoid, fissure surgery, cardiac pacemaker, or metal prosthesis
Prior treatment for prostate cancer 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 irritative or obstructive symptoms
Poor surgical risk (defined as American Society of Anesthesiology score \> 3).
Any condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions that significantly affect the life expectancy, chronic opiate use, pain syndrome, or drug abuse.)
Prostate size larger than 80 grams.
Subjects with prostatic Calcification (\>0.5 cc) close to the area to be treated.
Subjects with extraprostatic extension or cribriform pattern on biopsy.
Subjectes with sexual dysfunction defined as SHIM score \< 17
Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

What this trial measures

  • Recurrence free survival Recurrence free survival1 year after treatment

    Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy

  • Recurrence free survival2 years after treatment

    Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy

  • Recurrence free survival3 years after treatment

    Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy