Robotic Radical Perineal Prostatectomy Study

March 5, 2025 updated by: Chi Hang Yee, Chinese University of Hong Kong

Robotic Radical Perineal Prostatectomy for Localized Prostate Cancer: A Feasibility Study

Radical perineal prostatectomy (RPP) was the first approach utilized for the removal of the entire prostate gland for prostate cancer. In the minimally invasive surgery era, the robotic-assisted laparoscopic prostatectomy (RALP) was first described in the early 2000s, and has become the mainstay of prostatectomy in Hong Kong and many parts of the world. Incorporating the robotic technology into the technique of RPP has been studied recently. Some preliminary data showed that such approach resulted in a better functional outcome in continence and erectile function. Our study aims at assessing the safety and effectiveness of robotic RPP in prostate cancer management.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Radical perineal prostatectomy (RPP) was the first approach utilized for the removal of the entire prostate gland for prostate cancer [1]. It continued to be the favoured approach for radical prostatectomy for several decades before the description of the radical retropubic prostatectomy (RRP) by Walsh in 1970s, who has refined the anatomical retropubic approach [2]. In the minimally invasive surgery era, the robotic-assisted laparoscopic prostatectomy (RALP) was first described in the early 2000s [3]. With time, the robotic retropubic approach became one of the most common approaches for prostate removal in prostate cancer patients. In parallel with the implementation of robotic surgery in retropubic prostatectomy, a revival in interest was experienced for the RPP approach in its role for the management of localized prostate cancer. In 2003, Resnick reported a cohort of RPP with reasonable operative times and cancer control concluding that the procedure was safe and effective [4]. Janoff and Parra noted that in comparison to RRP, patients undergoing RPP had less postoperative discomfort, shorter return of bowel function and hospital stay with a decreased transfusion rate [5]. Incorporating the robotic technology into the technique of RPP, Kaouk et al. performed robotic RPP in four patients with localized prostate cancer using a multi-arm da Vinci Surgical system (Intuitive Surgical Inc., Sunnyvale, CA). The procedures were successfully completed applying a robotic perineal approach with patients discharged within 48 hours [6]. Tugku et al reported their clinical experience with 15 patients who underwent robotic RPP [7]. Early continence rate was shown to be 40% at urethral catheter removal and 94% at third months postoperatively. Furthermore, a study was performed by the same group comparing outcomes of robotic RPP versus transperitoneal RALP [8]. Eighty patients (40 robotic RPP vs 40 RALP) with localized prostate cancer were included in the study. Continence rates were 94% in the robotic RPP and 72% in the RALP (p = 0.001) group at the 6th-month follow-up. In terms of erectile function, the rates favoured robotic RPP at 3, 6, and 9-month follow-ups with 44%, 66%, and 75%, respectively. In addition, compared with conventional RALP, robotic RPP would offer an advantage for those patients who had previous intra-abdominal surgery. Moreover, not having the need of putting the patients into steep Trendelenburg position is another potential benefit of robotic RPP over conventional RALP. In this study, we evaluate the early oncological outcome and objective functional outcome of patients undergoing robotic RPP for the treatment of localized prostate cancer.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men aged between 40 - 80 years
  • Localized prostate cancer without obvious lymph node or distant metastases

Exclusion Criteria:

  • Clinical T stage T3 or above
  • Prostate size >80 ml
  • Patients with previous treatment of prostate cancer
  • Patients with previous surgery on the prostate
  • Patients with active urinary tract infection
  • Patients with bladder pathology including bladder stone and bladder cancer
  • Patients with urethral stricture
  • Patients with neurogenic bladder and/or sphincter abnormalities
  • Patients who fail to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robotic perineal radical prostatectomy
The patient is laid in the exaggerated lithotomy and 15 degree Trendelenburg position. An incision is made between both ischial tuberosities. Perineal dissection is performed till the apex of the prostate is seen. Subcutaneous tissue laying under the incision borders is dissected deeply over the superficial perineal fascia to place the GelPOINT®.Once the robotic system is docked, dissection of prostate is started.
Device: GelPOINT®
The patient is laid in the exaggerated lithotomy and 15 degree Trendelenburg position. An incision is made between both ischial tuberosities. Perineal dissection is performed till the apex of the prostate is seen. Subcutaneous tissue laying under the incision borders is dissected deeply over the superficial perineal fascia to place the GelPOINT®.Once the robotic system is docked, dissection of prostate is started.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of robotic RPP
Time Frame: During the 1-year post-operation study period
As defined by completion of prostatectomy via robotic perineal approach
During the 1-year post-operation study period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications after study intervention
Time Frame: During the 1-year post-operation study period
Post treatment complication
During the 1-year post-operation study period
Positive margin rate
Time Frame: At week-6
Positive margin rate in the prostatectomy specimen pathology
At week-6
Disease recurrence
Time Frame: During the 1-year post-operation study period
Any biochemical recurrence
During the 1-year post-operation study period
Functional outcome after robotic RPP
Time Frame: At immediate post-operation, 2-month, 6-month, 9-month and 12-month
Change in scores in EPIC-26 questionnaires
At immediate post-operation, 2-month, 6-month, 9-month and 12-month
Quality of life after robotic RRP
Time Frame: At immediate post-operation, 2-month, 6-month, 9-month and 12-month
Change in scores in IPSS questionnaires
At immediate post-operation, 2-month, 6-month, 9-month and 12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

March 23, 2020

First Submitted That Met QC Criteria

June 2, 2021

First Posted (Actual)

June 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRE 2020.019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Robotic Radical Perineal Prostatectomy

Clinical Trials on GelPOINT®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe