Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment

Not Applicable

• Conditions: Prostate Cancer
• Interventions: Procedure: Radical prostatectomy

• Registration Number: NCT04011865
• Lead Sponsor: Binh Dan Hospital

Brief Summary

This study is to compare the outcomes of robotic-assisted laparoscopic radical prostatectomy (RARP) and laparoscopic radical prostatectomy (LRP) for prostate cancer treatment in terms of perioperative surgical, functional and oncological outcomes.

Detailed Description

Participants will either have robotic-assisted laparoscopic radical prostatectomy (RARP) or laparoscopic radical prostatectomy (LRP) as determined by the treating surgeon. All participants will undergo tests and questionnaires to determine urinary and erectile function, biopsies to determine perioperative surgical, functional and oncological outcomes. These assessments will be conducted pre-operatively, post-operatively and at certain follow-up time points up to 12 months.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-07-04
• Study First Posted: 2019-07-09
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-12
• Last Update Posted: 2020-07-14
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

1. Adult men aged 18 years and over;
2. Undergoing RARP or LRP. prostatectomy for prostate cancer at Binh Dan Hospital;
3. Clinically suitable for radical prostatectomy (cT1-3, No, Mo);
4. Cognitively able to give written informed consent for participation;
5. Elective procedure.

Exclusion Criteria

1. The patient lacks the ability to consent for themselves;
2. Patients unwilling to undergo pre- and post-operative evaluation according to the protocol;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic surgery	Radical prostatectomy	-
Robotic-assisted surgery	Radical prostatectomy	-

Primary Outcome Measures

Name	Time	Method
The drainage time	Up to 3 months after surgery	(day),
To assess urethral catheter time, urethral catheter time	Up to 3 months after surgery	(day)
Perioperative transfusion rate (%)	Up to 1 month after operation	The number of cases which will be transfused.
The console time	During the surgery	The time which surgeon spends on the robot console by minuite
The postoperative recovery parameters using Numeric Pain Rating Scale (NPRS),	Up to 3 month after surgery	The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain, in a total of 10 points, higher score means worse, with 0 means no pain and 10 is the worst pain. The mean score will be calculated to reflect the post-operative pain.
The rate of postoperative complications (including infections)	in day 3, day 7, and 1 month after surgery.	Percentage
PSA level in blood	12 months post-operation	(mg/mL)
To assess postoperative hospital stay	Up to 1 month after surgery	(day)
Mean of blood loss	During the surgery	Milliliter
the rate of conversion to open surgery, the rate of intraoperative incidents (%),	Up to 1 weeks after the surgery.	Percentage
The rate of positive surgical margins, extracapsular extension, seminal vesicle invasion, (5)perineural invasion, the number of lymph node yield and node involvement,	Up to 1 week after operation	Number of cases, based on the result of pathology.
To assess bowel movement recovery time,	Up to 1 week after surgery	(day)
local and regional recurrences on sonography	through study completion, an average of 1 year	including ultrasound when PSA rising or any indication of recurrent
local and regional recurrences, on MRI	through study completion, an average of 1 year	including MRI when PSA rising or any indication of recurrent
local and regional recurrences, on PET Scan	through study completion, an average of 1 year	including PET Scan, when PSA rising or any indication of recurrent
Number of blood units transfused	Up to 1 week after operation	Milliliter
Change of hemoglobin from baseline	Up to 1 week after operation	(mg/mL)

Secondary Outcome Measures

Name	Time	Method
Evaluating the pre and postoperative lower urinary tract symptoms using International Prostate Symptoms Scores (IPSS)	3 months postoperative	It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life. The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points. The sum score will be calculated and the mean score will be evaluated.
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)	12 months postoperative.	It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life. The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points. The sum score will be calculated and the mean score will be evaluated.
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire	12 months postoperative	The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The mean score will be calculated.
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score	12 months postoperative	The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity). The mean score will be calculated.

Trial Locations

Locations (1)

Binh Dan Hospital; 🇻🇳 Ho Chi Minh City, Vietnam