Clinical trial · Interventional
Robotic Radical Perineal Prostatectomy Study
Robotic Radical Perineal Prostatectomy for Localized Prostate Cancer: A Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Why stopped (as posted): Study abandon due to logistical issues
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Robotic Radical Perineal Prostatectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GelPOINT® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Robotic perineal radical prostatectomy
- description
- 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.
- interventionNames
- Device: GelPOINT®
Primary outcomes (1)
- measure
- Feasibility of robotic RPP
- timeFrame
- During the 1-year post-operation study period
- description
- As defined by completion of prostatectomy via robotic perineal approach
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (9)
- BACKGROUNDDavis 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. PMID 4651353
- BACKGROUNDWalsh 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. PMID 6889192
- BACKGROUNDBinder 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. PMID 11251539
- BACKGROUNDResnick MI. Radical perineal prostatectomy. BJU Int. 2003 Oct;92(6):522-3. doi: 10.1046/j.1464-410x.2003.04423.x. No abstract available. PMID 14511023
- BACKGROUNDJanoff 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. PMID 15879765
- BACKGROUNDKaouk 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. PMID 27233935
- BACKGROUNDTugcu 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. PMID 29201511
- BACKGROUNDTugcu 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.