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Robotic Radical Perineal ProstatectomyNCT04919057

Robotic Radical Perineal Prostatectomy Study

A study testing GelPOINT® in people with Robotic Radical Perineal Prostatectomy, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

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… Read more about this study

Who is it for?
Ages 40 to 80 years, men only
Conditions the study is for
Robotic Radical Perineal Prostatectomy
What is being tested?
GelPOINT®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteHong Kong
Study dates
1 Jul 2025to 31 Mar 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • Patients with urethral stricture
  • Patients with neurogenic bladder and/or sphincter abnormalities
  • Patients who fail to give informed consent

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Prince of Wales Hospital, Chinese University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: 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.

Read the 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.

Being tested
GelPOINT®
Keywords
Robotic Radical Prostatectomy, Perineal, Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GelPOINT®Device

    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.

Study groups in NCT04919057
Study groupRoleWhat they receive
Robotic perineal radical prostatectomyExperimentalThe 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.
Receives: Device: GelPOINT®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of robotic RPP

    As defined by completion of prostatectomy via robotic perineal approach

    Measured: During the 1-year post-operation study period

Secondary outcomes (5)
  1. Complications after study intervention

    Post treatment complication

    Measured: During the 1-year post-operation study period

  2. Positive margin rate

    Positive margin rate in the prostatectomy specimen pathology

    Measured: At week-6

  3. Disease recurrence

    Any biochemical recurrence

    Measured: During the 1-year post-operation study period

  4. Functional outcome after robotic RPP

    Change in scores in EPIC-26 questionnaires

    Measured: At immediate post-operation, 2-month, 6-month, 9-month and 12-month

  5. Quality of life after robotic RRP

    Change in scores in IPSS questionnaires

    Measured: At immediate post-operation, 2-month, 6-month, 9-month and 12-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2021
  2. Study start1 Jul 2025 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Mar 2026 (estimated)

Why it stopped: Study abandon due to logistical issues

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04919057
Sponsor's protocol ID
CRE 2020.019
Status last verified
Sep 2026
First submitted
23 Mar 2020
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Davis WH, Scardino PL, Carlton FE. Radical perineal prostatectomy: a 20-year overview. J Urol. 1972 Oct;108(4):604-8. doi: 10.1016/s0022-5347(17)60814-0. No abstract available.

    PubMed 4651353
  • Walsh PC, Lepor H, Eggleston JC. Radical prostatectomy with preservation of sexual function: anatomical and pathological considerations. Prostate. 1983;4(5):473-85. doi: 10.1002/pros.2990040506.

    PubMed 6889192
  • Binder J, Kramer W. Robotically-assisted laparoscopic radical prostatectomy. BJU Int. 2001 Mar;87(4):408-10. doi: 10.1046/j.1464-410x.2001.00115.x. No abstract available.

    PubMed 11251539
  • Resnick MI. Radical perineal prostatectomy. BJU Int. 2003 Oct;92(6):522-3. doi: 10.1046/j.1464-410x.2003.04423.x. No abstract available.

    PubMed 14511023
  • Janoff DM, Parra RO. Contemporary appraisal of radical perineal prostatectomy. J Urol. 2005 Jun;173(6):1863-70. doi: 10.1097/01.ju.0000161483.65619.b3.

    PubMed 15879765
  • Kaouk JH, Akca O, Zargar H, Caputo P, Ramirez D, Andrade H, Albayrak S, Laydner H, Angermeier K. Descriptive Technique and Initial Results for Robotic Radical Perineal Prostatectomy. Urology. 2016 Aug;94:129-38. doi: 10.1016/j.urology.2016.02.063. Epub 2016 May 24.

    PubMed 27233935
  • Tugcu V, Akca O, Simsek A, Yigitbasi I, Sahin S, Tasci AI. Robot-assisted radical perineal prostatectomy: first experience of 15 cases. Turk J Urol. 2017 Dec;43(4):476-483. doi: 10.5152/tud.2017.35488. Epub 2017 Dec 1.

    PubMed 29201511
  • Tugcu V, Akca O, Simsek A, Yigitbasi I, Sahin S, Yenice MG, Tasci AI. Robotic-assisted perineal versus transperitoneal radical prostatectomy: A matched-pair analysis. Turk J Urol. 2019 Apr 3;45(4):265-272. doi: 10.5152/tud.2019.98254. Print 2019 Jul.

    PubMed 30978167
  • Tugcu V, Akca O, Simsek A, Yigitbasi I, Yenice MG, Sahin S, Tasci AI. Robotic perineal radical prostatectomy and robotic pelvic lymph node dissection via a perineal approach: The Tugcu Bakirkoy Technique. Turk J Urol. 2018 Mar;44(2):114-118. doi: 10.5152/tud.2018.24603. Epub 2018 Mar 1.

    PubMed 29511579

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