RecruitingNot ApplicableNCT05610852

Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound

Prospective Single-Center Randomized Study Of Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound (HIFU)


Sponsor

Case Comprehensive Cancer Center

Enrollment

276 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study compares two surgical approaches for treating localized prostate cancer: a new single-incision surgery that goes through the bladder (transvesical partial prostatectomy) versus high-intensity focused ultrasound (HIFU), which uses sound waves to destroy the tumor without cutting. **You may be eligible if...** - You have biopsy-confirmed prostate cancer (stage T1a to T2c based on MRI) - Your PSA (prostate-specific antigen) is 10 ng/mL or lower - Your MRI shows a region of concern rated PIRADs grade 3 or higher - Your MRI includes required imaging sequences (T2-weighted and diffusion imaging) **You may NOT be eligible if...** - Your prostate cancer is higher stage (T3 or beyond) - Your PSA is above 10 ng/mL - Your MRI region of interest is rated below PIRADs 3 - You have other significant health conditions that may prevent surgery or HIFU Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETransvesical 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.

PROCEDUREHigh-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.


Locations(1)

Glickman Urological & Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

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NCT05610852


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