Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Radical prostatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men aged 18 years and over; Undergoing RARP or LRP. prostatectomy for prostate cancer at Binh Dan Hospital; Clinically suitable for radical prostatectomy (cT1-3, No, Mo); Cognitively able to give written informed consent for participation; Elective procedure. Exclusion Criteria: The patient lacks the ability to consent for themselves; Patients unwilling to undergo pre- and post-operative evaluation according to the protocol;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Robotic-assisted surgery<br> | Procedure: Radical prostatectomy<br>* The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.<br>|
| Sham Comparator: Laparoscopic surgery<br> | Procedure: Radical prostatectomy<br>* The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The console time | The time which surgeon spends on the robot console by minuite | During the surgery | 
| Mean of blood loss | Milliliter | During the surgery | 
| Perioperative transfusion rate (%) | The number of cases which will be transfused. | Up to 1 month after operation | 
| The rate of positive surgical margins, extracapsular extension, seminal vesicle invasion, (5)perineural invasion, the number of lymph node yield and node involvement, | Number of cases, based on the result of pathology. | Up to 1 week after operation | 
| Number of blood units transfused | Milliliter | Up to 1 week after operation | 
| the rate of conversion to open surgery, the rate of intraoperative incidents (%), | Percentage | Up to 1 weeks after the surgery. | 
| The postoperative recovery parameters using Numeric Pain Rating Scale (NPRS), | 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. | Up to 3 month after surgery | 
| Change of hemoglobin from baseline | (mg/mL) | Up to 1 week after operation | 
| The drainage time | (day), | Up to 3 months after surgery | 
| To assess urethral catheter time, urethral catheter time | (day) | Up to 3 months after surgery | 
| To assess bowel movement recovery time, | (day) | Up to 1 week after surgery | 
| To assess postoperative hospital stay | (day) | Up to 1 month after surgery | 
| The rate of postoperative complications (including infections) | Percentage | in day 3, day 7, and 1 month after surgery. | 
| PSA level in blood | (mg/mL) | Before operation | 
| PSA level in blood | (mg/mL) | 6 weeks post-operation | 
| PSA level in blood | (mg/mL) | 3 months post-operation | 
| PSA level in blood | (mg/mL) | 6 months post-operation | 
| PSA level in blood | (mg/mL) | 12 months post-operation | 
| local and regional recurrences on sonography | including ultrasound when PSA rising or any indication of recurrent | through study completion, an average of 1 year | 
| local and regional recurrences, on MRI | including MRI when PSA rising or any indication of recurrent | through study completion, an average of 1 year | 
| local and regional recurrences, on PET Scan | including PET Scan, when PSA rising or any indication of recurrent | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS) | 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. | Preoperative | 
| Evaluating the pre and postoperative lower urinary tract symptoms using International Prostate Symptoms Scores (IPSS) | 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. | 3 months postoperative | 
| Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS) | 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. | 6 months, postoperative | 
| Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS) | 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. | 12 months postoperative. | 
| Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score | 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. | Preoperative | 
| Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score | 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. | 3 months, postoperative | 
| Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score | 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. | 6 months, postoperative. | 
| Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score | 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. | 12 months postoperative | 
| The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire | 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. | Preoperative | 
| The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire | 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. | 3 months, postoperative. | 
| The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire | 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. | 6 months, postoperative | 
| The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire | 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. | 12 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic radical prostatectomy, robotic-assisted laparoscopic radical prostatectomy, prostate cancer