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.
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®
- Type of treatment
- Injection or infusion, Medical device
- 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
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.
- Conditions
- Robotic Radical Perineal Prostatectomy
- 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 group | Role | What they receive |
|---|---|---|
| Robotic perineal radical prostatectomy | Experimental | 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. Receives: Device: GelPOINT® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Complications after study intervention
Post treatment complication
Measured: During the 1-year post-operation study period
Positive margin rate
Positive margin rate in the prostatectomy specimen pathology
Measured: At week-6
Disease recurrence
Any biochemical recurrence
Measured: During the 1-year post-operation study period
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
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.
- First posted9 Jun 2021
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Why it stopped: Study abandon due to logistical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Robotic Radical Perineal ProstatectomyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi Hang Yee, Chinese University of Hong Kong
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 4651353Walsh 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 6889192Binder 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 11251539Resnick 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 14511023Janoff 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 15879765Kaouk 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 27233935Tugcu 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 29201511Tugcu 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 30978167Tugcu 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