Clinical trial NCT02687308: Open Anterograde Radical Prostatectomy Compared to Open Retrograde Technique
Official title: Open Retropubic Radical Prostatectomy With Anterograde Anatomical Dissection Technique (RRP2A), Compared With Walsh Open Anatomical Retrograde Radical Prostatectomy (RRP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Cancer
Prostatic Neoplasm
Keywords: Prostatic cancer
Radical prostatectomy
Minimally invasive prostate cancer surgery
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 240
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Introduction The best way to treat localized prostate cancer is radical prostatectomy (RP). This surgery has been performed since 1905, introduced by Young. Initial results were disappointing due to high rates of bleeding, incontinence, impotence and other surgical complications. It was from the knowledge of the anatomical basis of vascularization and innervation of male pelvis by Patrick Walsh that the radical retropubic prostatectomy (RRP) had its development and has become the first choice in the treatment of initial stages of prostate cancer.

Large series of literature results show excellent long-term cancer control, with about 80% of patients with no evidence of disease (biochemical or clinical) in 10 years.

Urinary incontinence rates after RRP vary widely, those regarding absence of the urinary incontinence after 18 months of surgery are uniform in presenting continence rates above 90%. However the continence rates over the short term are much lower.

The definition of recovery of sexual function after surgery is the ability to keep satisfactory sexual intercourse with or without the use of oral drugs. The key factors for the recovery of erectile capacity power prior to surgery are the patient's age and the surgical technique employed. Academic series of open RRP report recovery rates of about 70% with bilateral preservation of nerves, and about 50% with unilateral preservation after 18 months.

Recent studies have shown benefits in the minimally invasive approaches, laparoscopic radical prostatectomy (LRP) and, more recently, robot-assisted radical prostatectomy (RARP), with respect to complications like intraoperative bleeding, but still do not demonstrate conclusively advantages as oncological control. However the recovery of erectile function and urinary continence seems to recover better and earlier. It is believed that there are about 200-250 cases of learning curve to reach levels that the rates of complications and positive surgical margins become stable and similar to the open radical prostatectomy, and the high cost of robotic technology still has limited the generalization of this approach in many countries.

The exponential adoption of minimally invasive robot-assisted radical prostatectomy (RARP) has been remarkable and unprecedented. According to unverified estimates from the Da Vinci surgical system manufacturer (Intuitive Surgical, Sunnyvale, CA) over 80% of radical prostatectomy within the US were performed robotically in 2010. This dramatic shift in radical prostatectomy practice patterns occurred despite the lack of evidence of high quality of the method, not yet demonstrating its oncology benefits, safety or cost effectiveness compared to open surgery.

While the majority of studies made by comparing the radical prostatectomy: robot X laparoscopic X open, show a slight advantage in the first two in regard intraoperative complications, especially bleeding, and post operative complications as the speed of recovery of continence and sexual potency. 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 prostate surgery was based on an entirely different anatomical benchmark of that described by Patrick Walsh for open radical prostatectomy.

While robotics and laparoscopic 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, incremental or not careful nerve-sparing procedures with meticulous rectoprostatic dissection of the posterior layer of Denonvilliers' fascia, with the aim of maximizing the preservation of the fibers located within the periprostatic tissue that covers the lateral and anterior surface of the prostate, and urethrovesical anastomosis performed through a monofilament running suture. The Walsh open radical retropubic prostatectomy (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.

This trial proposes a prospective randomized study performing radical prostatectomy due to open surgery using the same technique of minimally invasive surgery, antegrade, from bladder neck to the apex, with careful bladder neck dissection and preservation, incremental or not careful nerve-sparing procedures and urethrovesical anastomosis performed by monofilament running suture, described by the Pasadena consensus for the procedure assisted by robot.

A pilot study was performed to test the feasibility of this technique and managed to complete ten surgeries in all its stages without conversion to the standard radical prostatectomy technique of Patrick Walsh.

Patients and methods

This technique will be performed by incision (open surgery) and will be compared with the anatomical radical prostatectomy technique described by Patrick Walsh and performed by the same surgeons.

Two hundred and forty patients will be selected with localized prostate cancer with indication for radical surgery, confirmed by biopsy and staged as protocol of urology service HUPE UERJ of Rio de Janeiro, Brazil.

Patients will be randomized into two arms, according to the kind of technique, and in three sets according to the three different main surgeons. Randomization was performed by software on the site "www.randomizer.org/" on November 17, 2015, as follows:

Arm 1 - open retrograde radical retropubic prostatectomy (RRP).

Arm 2 - open anterograde anatomical radical retropubic prostatectomy (RRP2A).

Set 1 - Surgeon A. 1, 1, 2, 2, 1, 2, 2, 2, 1, 1, 1, 2, 1, 1, 1, 2, 2, 1, 1, 1, 1, 2, 2, 1, 2, 2, 1, 2, 1, 2, 2, 2, 2, 2, 2, 1, 2, 1, 1, 2, 2, 2, 1, 1, 2, 2, 2, 2, 2, 2, 2, 1, 2, 1, 2, 2, 1, 1, 2, 2, 1, 2, 1, 2, 1, 1, 2, 2, 2, 2, 1, 1, 1, 1, 2, 1, 1, 1, 1, 1

Set 2 - Surgeon B. 2, 2, 2, 1, 1, 2, 1, 1, 1, 2, 1, 1, 1, 2, 1, 2, 2, 2, 2, 1, 1, 2, 2, 2, 2, 2, 2, 2, 2, 1, 1, 2, 2, 2, 1, 2, 2, 2, 2, 2, 2, 1, 2, 2, 1, 2, 1, 2, 1, 1, 1, 2, 2, 2, 1, 2, 2, 2, 2, 1, 2, 2, 2, 2, 1, 1, 2, 2, 2, 2, 2, 1, 1, 2, 2, 2, 1, 2, 2, 1

Set 3 - Surgeon C. 2, 2, 1, 2, 2, 1, 1, 1, 1, 1, 2, 2, 2, 2, 1, 2, 2, 1, 2, 2, 1, 1, 1, 2, 2, 1, 2, 1, 2, 2, 2, 2, 2, 1, 1, 1, 2, 2, 2, 1, 2, 1, 1, 2, 1, 2, 1, 1, 1, 2, 1, 2, 1, 1, 1, 2, 2, 1, 1, 1, 1, 2, 2, 1, 1, 1, 2, 2, 2, 1, 1, 1, 1, 1, 1, 2, 2, 1, 2, 2

A prostatectomy technique of "open anterograde anatomical radical retropubic prostatectomy (RRP2A)" dissects the prostate, bladder neck and the neurovascular bundle, antegrade, from bladder neck to the apex, with careful bladder neck dissection and preservation, incremental or not careful nerve-sparing procedures with meticulous rectoprostatic dissection of the posterior layer of Denonvilliers' fascia, with the aim of maximizing the preservation of the fibers located within the periprostatic tissue that covers the lateral and anterior surface of the prostate, and urethrovesical anastomosis performed through a monofilament running suture, follow the step-by-step described in Pasadena consensus for robot-assisted radical prostatectomy and adapted to open surgery.

Selection of Study Population Patients will be selected with localized prostate cancer confirmed by biopsy and staged as protocol of urology service of Pedro Ernesto Hospital of State University of Rio de Janeiro, Brazil (HUPE UERJ). All patients with localized prostate cancer and indication for open radical retropubic prostatectomy (RRP) will be invited to participate in this study.

The Visits Procedures:

Day 0. Screening may be performed before or in the same visit of Randomization with the patient signed the informed consent before or in the day of surgery.

Evaluation of inclusion and exclusion criteria. Randomization may also be performed just before starting the surgical procedure. Patient identification as age and race, as well data as result of the biopsy, prostate specific antigen (PSA) levels and clinical stage are transcribed to the protocol. The surgery information is recorded in details at the end of surgery. Model protocol annotation form in appendix 1.

Visit 1 - Day 7 to RRP2A and day 14 for RRP. In this visit the bladder catheter is taken and collected information of postoperative complications, time and drainage volume of suction drain, wound aspect, length of hospital stay.

After removal of the bladder catheter will be observed if the patient has a urethral drip or if he can retain urine in the bladder.

PSA dosage will be requested. Visit 2 - Day 30. This visit will be harvested postoperative complications information, PSA results and the result of the pathological examination of the surgical specimens, prostate, seminal vesicles and pelvic nodes. Evaluation of the surgical margins, urethral, bladder and circumferential and pathological staging.

In this visit will be applied two questionnaires for evaluation of urinary continence and sexual function, International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and International Index of Erectile Function-5 (IIEF5).

In this visit the patients will also be asked about their continence, if they are completely continent, ie, without the use of any pad, or partial continent, use of only one pad per day for protection against accidents. If this one pad is used only to protect any occasional urine leakage, but not wets every day, he will be asked how many times a week this pad is wet, with the following response options: once, twice, three times or more, almost every day or all days of the week. If the patient answers that the pad wets once or twice a week, he will be considered partial continent, to answer it wets three or more times, almost every day or every day of the week, the patient will be considered incontinent.

Visit 3 - Day 60. This visit will be harvested postoperative complications information, PSA results and the result of the pathological examination of the surgical specimens if these results are not ready in the previous visit. Application of the questionnaires ICIQ-SF and IIEF5. In this visit will also be asked to the patients about their continence, classified as completely continent, partial continent and incontinent. They will be also asked about sexual intercourse with penetration and if they are using medication as phosphodiesterase type 5 (PDE5) inhibitors.

Visit 4 - Day 90. This visit will be harvested postoperative complications information and PSA results.

Application of the questionnaires ICIQ-SF and IIEF5. In this visit it will also be asked to the patients about their continence, classified as completely continent, partial continent and incontinent. They will be ask also about sexual intercourse with penetration and if they are using medication as PDE5 inhibitors.

Visit 5 - Day 180. This visit will be assessed the result of PSA. Application of the questionnaires ICIQ-SF and IIEF5 and asked to patients about their continence, classified as completely continent, partial continent and incontinent. They will also be asked about sexual intercourse with penetration and if they are using medication as PDE5 inhibitors.

Visit 6 - 1 year - End of Study. This visit will be assessed the result of PSA. Application of the questionnaires ICIQ-SF and IIEF5 and ask the patients about their continence, classified as completely continent, partial continent and incontinent. They will also be asked about sexual intercourse with penetration and if they are using medication as PDE5 inhibitors.

Eligibility criteria: 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.

Primary outcomes:
measure: Surgical time for completed prostatectomy
timeFrame: Day of surgery
Secondary outcomes:
measure: PSA
timeFrame: One year
measure: Time of urinary catheter
timeFrame: Three months
measure: Time of urethrovesical anastomosis
timeFrame: Day of surgery
measure: Hospital length of stay
timeFrame: One month
measure: Positive surgical margins
timeFrame: Three months
measure: Urinary Continence
timeFrame: One year
measure: Erectile function
timeFrame: One year
measure: Surgical complication
timeFrame: Three months postsurgery
measure: Postoperative complications
timeFrame: One year
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: State University of Rio de Janeiro
Study officials:
affiliation: State University of Rio de Janeiro
name: Fabricio B Carrerette
role: PRINCIPAL_INVESTIGATOR
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