Clinical trial · Interventional
Open Anterograde Radical Prostatectomy Compared to Open Retrograde Technique
Open Retropubic Radical Prostatectomy With Anterograde Anatomical Dissection Technique (RRP2A), Compared With Walsh Open Anatomical Retrograde Radical Prostatectomy (RRP)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective randomized study performing open anterograde anatomical radical retropubic prostatectomy (RRP2A) using the same technique of minimally invasive surgery described by the Pasadena consensus for the procedure assisted by robot, compared with the anatomical radical prostatectomy technique described by Patrick Walsh (RRP). Recent studies have shown benefits in the minimally invasive surgical techniques approaches, laparoscopic radical prostatectomy (LRP) and, more recently, robot-assisted radical prostatectomy (RARP). These minimally invasive techniques were associated with advantages in complications, like intraoperative bleeding, transfusion rates and in earlier recovery of important genitourinary functions such as urinary continence and penile erection. But still has not been demonstrated conclusively advantages as oncological control and it is believed that there are about 200 to 250 cases of learning curve so that the rates of complications and positive surgical margins become stable and similar to the open radical prostatectomy. These facts associated with the high cost of robotic technology still have limited the generalization of this approach in many developing countries such as Brazil. While the majority of studies made by comparing the radical prostatectomy (RP), robot X laparoscopic X open, show a slight advantage in the first two, there is a significant bias in these studies, which is that the surgical technique used in each procedure differs significantly from minimally invasive and open surgical techniques. The evolution of minimally invasive radical prostatectomy was based on an entirely different anatomical benchmark of that described by Patrick Walsh. While robotics and laparoscopic techniques dissect the prostate, bladder neck and the neurovascular bundle in an antegrade way, from bladder neck to the apex, the Walsh RRP technique is completely different in several ways, the dissection is made from prostatic apex to the bladder neck, so the retrograde direction, the posterior layer of Denonvilliers' fascia, is always included with the specimen, and urethrovesical anastomosis, usually performed with multifilament interrupted suture, only for indicating the major differences. The RRP2A will be performed by incision (open surgery) and will be compared with the anatomical radical prostatectomy technique described by Patrick Walsh RRP, and performed by the same surgeons.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Cancer | — | UNRESOLVED | — |
| Prostatic Neoplasm | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1 Retrograde radical prostatectomy RRP | Procedure | — | UNRESOLVED |
| 2 Anterograde radical prostatectomy RRP2A | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1Retrograde radical prostatectomy RRP
- description
- This opem surgical prostatectomy techniques described by Patrick Walsh is made through prostatic dissection, from apex to the bladder neck, so the retrograde direction, the posterior layer of Denonvilliers' fascia is always included with the specimen, and urethrovesical anastomosis usually performed with multifilament interrupted suture
- interventionNames
- Procedure: 1 Retrograde radical prostatectomy RRP
- type
- EXPERIMENTAL
- label
- 2Anterograde radical prostatectomy RRP2A
- description
- This opem surgical prostatectomy techniques dissect the prostate, bladder neck and the neurovascular bundle, in an antegrade way, from bladder neck to the apex. With careful bladder neck dissection and preservation, careful nervesparing procedures with meticulous retroprostatic dissection of the posterior layer of Denonvilliers' fascia, and urethrovesical anastomosis performed through a monofilament running suture.
- interventionNames
- Procedure: 2 Anterograde radical prostatectomy RRP2A
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 40 years or older and willing and able to provide informed consent; 2. Histologically and clinically confirmed localized adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features; 3. Surgical indication for open radical prostatectomy; 4. PSA less than 20 ng/mL; 5. No evidence of metastasis disease; 6. Cleared by the primary medical doctor for surgery; 7. No prior systemic therapy for prostate cancer; 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: 1. Refuses to give informed consent; 2. Refuses or is unable to have radical prostatectomy; 3. Stage T4; 4. Deemed a poor surgical risk per primary medical doctor; 5. Received prior therapeutic intervention for prostate cancer; 6. Deep vein thrombosis (DVT)/pulmonary embolism (PE) in the past 6 months; 7. Neurogenic bladder; 8. Urinary incontinence.
References
Publications (30)
- BACKGROUNDYatani R, Chigusa I, Akazaki K, Stemmermann GN, Welsh RA, Correa P. Geographic pathology of latent prostatic carcinoma. Int J Cancer. 1982 Jun 15;29(6):611-6. doi: 10.1002/ijc.2910290602. PMID 7107064
- BACKGROUNDFicarra V, Borghesi M, Suardi N, De Naeyer G, Novara G, Schatteman P, De Groote R, Carpentier P, Mottrie A. Long-term evaluation of survival, continence and potency (SCP) outcomes after robot-assisted radical prostatectomy (RARP). BJU Int. 2013 Aug;112(3):338-45. doi: 10.1111/bju.12001. Epub 2013 Mar 7. PMID 23470027
- RESULTWalsh PC, Donker PJ. Impotence following radical prostatectomy: insight into etiology and prevention. J Urol. 1982 Sep;128(3):492-7. doi: 10.1016/s0022-5347(17)53012-8. No abstract available. PMID 7120554
- RESULTMohler J, Bahnson RR, Boston B, Busby JE, D'Amico A, Eastham JA, Enke CA, George D, Horwitz EM, Huben RP, Kantoff P, Kawachi M, Kuettel M, Lange PH, Macvicar G, Plimack ER, Pow-Sang JM, Roach M 3rd, Rohren E, Roth BJ, Shrieve DC, Smith MR, Srinivas S, Twardowski P, Walsh PC. NCCN clinical practice guidelines in oncology: prostate cancer. J Natl Compr Canc Netw. 2010 Feb;8(2):162-200. doi: 10.6004/jnccn.2010.0012. No abstract available. PMID 20141676
- RESULTWalsh PC, Partin AW, Epstein JI. Cancer control and quality of life following anatomical radical retropubic prostatectomy: results at 10 years. J Urol. 1994 Nov;152(5 Pt 2):1831-6. doi: 10.1016/s0022-5347(17)32396-0. PMID 7523730
- RESULTEastham JA, Scardino PT, Kattan MW. Predicting an optimal outcome after radical prostatectomy: the trifecta nomogram. J Urol. 2008 Jun;179(6):2207-10; discussion 2210-1. doi: 10.1016/j.juro.2008.01.106. Epub 2008 Apr 18. PMID 18423693
- RESULTCatalona WJ, Carvalhal GF, Mager DE, Smith DS. Potency, continence and complication rates in 1,870 consecutive radical retropubic prostatectomies. J Urol. 1999 Aug;162(2):433-8.