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Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound

NCT05610852 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2026-05-07

No results posted yet for this study

Summary

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

Interventions

PROCEDURE

Transvesical Single Port Robotic Partial Prostatectomy

A foley catheter is inserted on the sterile field. A suprapubic midline incision is made and the da Vinci SP surgical system is docked percutaneously directly to the bladder. Prior to the operation, a radiologist identifies and segments tumors and the urethra. A transrectal ultrasound probe is inserted and secured into a fixed position. The Koelis software is utilized to fuse MRI and ultrasound images to identify the target lesion in real-time, allowing for intraoperative guidance. The ultrasound probe rotates automatically, allowing for localization of the tumor intraoperatively. Then depending on the area of the tumor, a Hemi or quadrant resection is completed while preserving the nerves, vas deferens, and seminal vesicles. The urethrovesical anastomosis is then performed.

PROCEDURE

High-intensity focused ultrasound (HIFU)

Three contoured measurements are required for the MR fusion system to reproduce the volume of the prostate. Following this, the area to be targeted will be selected in graded fashion from the anterior to posterior of the prostate. Once planning of ROI (region of interest) is complete, the HIFU treatment may begin. Quadrant or hemi ablation will be performed based on the size and complexity of the tumor. The distal margin of the ablation will be kept at least 4 mm away from the external sphincter. The rectal temperature and its distance from the probe will be carefully monitored throughout the procedure.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2026-07-01
Completion
2028-07-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05610852 on ClinicalTrials.gov