Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound

Prostate Cancer Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostate Cancer

• NCT number: NCT05610852
• Study type: Interventional
• Source: Case Comprehensive Cancer Center
• Contact: Jihad Kaouk, MD
• Phone: 216-444-2976
• Email: kaoukj@ccf.org
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Completion date: July 1, 2028