NCT05610852

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective is to evaluate the in-field recurrence rates and recurrence free survival - defined as the absence of clinically significant prostate cancer within the treated zone (identified by prostate MRI and subsequent targeted prostate biopsy). Secondary objectives of interest are: * Perioperative parameters such as operative time, perioperative complications, analgesic requirement, postoperative hospital stay, foley catheter duration * Functional outcomes such as time to urinary continence, urinary continence, and erectile dysfunction * Oncologic outcomes such as biochemical recurrence rates (defined in section 2.1), recurrence free survival, presence of secondary intervention for prostate cancer (HIFU, radiation, surgery, ADT)

Conditions

• Prostate Adenocarcinoma
• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-07-01
• Completion: 2028-07-01
• First posted: 2022-11-09
• Last updated: 2025-07-30

Locations

1 site across 1 country: United States