Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound

  • Recruiting
  • Treatment
  • Interventional
  • Randomized
  • Procedure
  • Case Comprehensive Cancer Center
  • 19 Years -


Study Purpose

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.

Intervention

Procedure : Transvesical Single Port Robotic Partial Prostatectomy

Procedure : High-intensity focused ultrasound (HIFU)


Eligibility Requirements

info icon 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

info icon The MRI performed must include at least:

info icon 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,

info icon 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,

info icon 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

info icon 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.

info icon If necessary, subtracted images are calculated

info icon Clinically significant prostate cancer defined as Gleason score 3+4 or less in any core

info icon 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

info icon Life expectancy greater than 10 years.

info icon Age \>18 years.

info icon Subjects must have the ability to understand and the willingness to sign a written informed consent document.

info icon Patients with any prior extensive pelvic surgery, pelvic fractures, hemorrhoid, fissure surgery, cardiac pacemaker, or metal prosthesis

info icon Prior treatment for prostate cancer such as radiotherapy, focal or hormonal therapy

info icon Uncorrected coagulopathy or history of Latex allergy

info icon Active soft tissue or urinary infection, indwelling Foley catheter or severe irritative or obstructive symptoms

info icon Poor surgical risk (defined as American Society of Anesthesiology score \> 3).

info icon 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.)

info icon Prostate size larger than 80 grams.

info icon Subjects with prostatic Calcification (\>0.5 cc) close to the area to be treated.

info icon Subjects with extraprostatic extension or cribriform pattern on biopsy.

info icon Subjectes with sexual dysfunction defined as SHIM score \< 17

info icon 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.

Recruiting status

Recruiting

Estimated enrollment

276

 
Study start date

Jan 01, 2024

Study end date

Jul 01, 2028

Last updated

Mar 22, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Procedure

Study phase

NA

Allocation

Randomized

 

Sponsor:

Case Comprehensive Cancer Center

Collaborator:

N/A

Investigator:

Jihad Kaouk, MD

NCT05610852

Clinic Location Investigator Distance RECRUITING STATUS Contact