Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment

Prostate Cancer Clinical Trial

Official title:

Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04011865
• Other study ID #: BD022019
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2020
• Source: Binh Dan Hospital
• Contact: Hoang PC Nguyen, Associate Professor, MD, PhD
• Phone: +84 913 719 346
• Email: npchoang[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Radical prostatectomy
The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.

Locations

Country	Name	City	State
Vietnam	Binh Dan Hospital	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Binh Dan Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The console time	The time which surgeon spends on the robot console by minuite	During the surgery
Primary	Mean of blood loss	Milliliter	During the surgery
Primary	Perioperative transfusion rate (%)	The number of cases which will be transfused.	Up to 1 month after operation
Primary	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
Primary	Number of blood units transfused	Milliliter	Up to 1 week after operation
Primary	the rate of conversion to open surgery, the rate of intraoperative incidents (%),	Percentage	Up to 1 weeks after the surgery.
Primary	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
Primary	Change of hemoglobin from baseline	(mg/mL)	Up to 1 week after operation
Primary	The drainage time	(day),	Up to 3 months after surgery
Primary	To assess urethral catheter time, urethral catheter time	(day)	Up to 3 months after surgery
Primary	To assess bowel movement recovery time,	(day)	Up to 1 week after surgery
Primary	To assess postoperative hospital stay	(day)	Up to 1 month after surgery
Primary	The rate of postoperative complications (including infections)	Percentage	in day 3, day 7, and 1 month after surgery.
Primary	PSA level in blood	(mg/mL)	Before operation
Primary	PSA level in blood	(mg/mL)	6 weeks post-operation
Primary	PSA level in blood	(mg/mL)	3 months post-operation
Primary	PSA level in blood	(mg/mL)	6 months post-operation
Primary	PSA level in blood	(mg/mL)	12 months post-operation
Primary	local and regional recurrences on sonography	including ultrasound when PSA rising or any indication of recurrent	through study completion, an average of 1 year
Primary	local and regional recurrences, on MRI	including MRI when PSA rising or any indication of recurrent	through study completion, an average of 1 year
Primary	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	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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