Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011865
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Radical prostatectomy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: Robotic-assisted surgery 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.

Sham Comparator: Laparoscopic surgery 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.




Primary Outcome Measures :
  1. The console time [ Time Frame: During the surgery ]
    The time which surgeon spends on the robot console by minuite

  2. Mean of blood loss [ Time Frame: During the surgery ]
    Milliliter

  3. Perioperative transfusion rate (%) [ Time Frame: Up to 1 month after operation ]
    The number of cases which will be transfused.

  4. The rate of positive surgical margins, extracapsular extension, seminal vesicle invasion, (5)perineural invasion, the number of lymph node yield and node involvement, [ Time Frame: Up to 1 week after operation ]
    Number of cases, based on the result of pathology.

  5. Number of blood units transfused [ Time Frame: Up to 1 week after operation ]
    Milliliter

  6. the rate of conversion to open surgery, the rate of intraoperative incidents (%), [ Time Frame: Up to 1 weeks after the surgery. ]
    Percentage

  7. The postoperative recovery parameters using Numeric Pain Rating Scale (NPRS), [ Time Frame: 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.

  8. Change of hemoglobin from baseline [ Time Frame: Up to 1 week after operation ]
    (mg/mL)

  9. The drainage time [ Time Frame: Up to 3 months after surgery ]
    (day),

  10. To assess urethral catheter time, urethral catheter time [ Time Frame: Up to 3 months after surgery ]
    (day)

  11. To assess bowel movement recovery time, [ Time Frame: Up to 1 week after surgery ]
    (day)

  12. To assess postoperative hospital stay [ Time Frame: Up to 1 month after surgery ]
    (day)

  13. The rate of postoperative complications (including infections) [ Time Frame: in day 3, day 7, and 1 month after surgery. ]
    Percentage

  14. PSA level in blood [ Time Frame: Before operation ]
    (mg/mL)

  15. PSA level in blood [ Time Frame: 6 weeks post-operation ]
    (mg/mL)

  16. PSA level in blood [ Time Frame: 3 months post-operation ]
    (mg/mL)

  17. PSA level in blood [ Time Frame: 6 months post-operation ]
    (mg/mL)

  18. PSA level in blood [ Time Frame: 12 months post-operation ]
    (mg/mL)

  19. local and regional recurrences on sonography [ Time Frame: through study completion, an average of 1 year ]
    including ultrasound when PSA rising or any indication of recurrent

  20. local and regional recurrences, on MRI [ Time Frame: through study completion, an average of 1 year ]
    including MRI when PSA rising or any indication of recurrent

  21. local and regional recurrences, on PET Scan [ Time Frame: through study completion, an average of 1 year ]
    including PET Scan, when PSA rising or any indication of recurrent


Secondary Outcome Measures :
  1. Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS) [ Time Frame: Preoperative ]
    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.

  2. Evaluating the pre and postoperative lower urinary tract symptoms using International Prostate Symptoms Scores (IPSS) [ Time Frame: 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.

  3. Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS) [ Time Frame: 6 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.

  4. Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS) [ Time Frame: 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.

  5. Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score [ Time Frame: Preoperative ]
    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. Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score [ Time Frame: 3 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.

  7. Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score [ Time Frame: 6 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.

  8. Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score [ Time Frame: 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.

  9. The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire [ Time Frame: Preoperative ]
    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.

  10. The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire [ Time Frame: 3 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.

  11. The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire [ Time Frame: 6 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.

  12. The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011865


Contacts
Layout table for location contacts
Contact: Hoang PC Nguyen, Associate Professor, MD, PhD +84 913 719 346 npchoang@gmail.com
Contact: Linh NK Tran, MD, PhD +84 989 047 088 khaclinh@gmail.com

Locations
Layout table for location information
Vietnam
Binh Dan Hospital Recruiting
Ho Chi Minh City, Vietnam, 700000
Contact: Hoang PC Nguyen, Associate Professor, MD, PhD    +84 913 719 346    npchoang@gmail.com   
Sponsors and Collaborators
Binh Dan Hospital
Investigators
Layout table for investigator information
Study Director: Hung V Tran, MD, PhD Binh Dan Hospital
Layout table for additonal information
Responsible Party: Binh Dan Hospital
ClinicalTrials.gov Identifier: NCT04011865    
Other Study ID Numbers: BD022019
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Binh Dan Hospital:
laparoscopic radical prostatectomy
robotic-assisted laparoscopic radical prostatectomy
prostate cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases