Clinical trial NCT04011865: Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
Official title: Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: laparoscopic radical prostatectomy
robotic-assisted laparoscopic radical prostatectomy
prostate cancer
Lead sponsor: Binh Dan Hospital
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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;

Primary outcomes:
measure: The console time
timeFrame: During the surgery
measure: Mean of blood loss
timeFrame: During the surgery
measure: Perioperative transfusion rate (%)
timeFrame: Up to 1 month after operation
measure: The rate of positive surgical margins, extracapsular extension, seminal vesicle invasion, (5)perineural invasion, the number of lymph node yield and node involvement,
timeFrame: Up to 1 week after operation
measure: Number of blood units transfused
timeFrame: Up to 1 week after operation
measure: the rate of conversion to open surgery, the rate of intraoperative incidents (%),
timeFrame: Up to 1 weeks after the surgery.
measure: The postoperative recovery parameters using Numeric Pain Rating Scale (NPRS),
timeFrame: Up to 3 month after surgery
measure: Change of hemoglobin from baseline
timeFrame: Up to 1 week after operation
measure: The drainage time
timeFrame: Up to 3 months after surgery
measure: To assess urethral catheter time, urethral catheter time
timeFrame: Up to 3 months after surgery
measure: To assess bowel movement recovery time,
timeFrame: Up to 1 week after surgery
measure: To assess postoperative hospital stay
timeFrame: Up to 1 month after surgery
measure: The rate of postoperative complications (including infections)
timeFrame: in day 3, day 7, and 1 month after surgery.
measure: PSA level in blood
timeFrame: Before operation
measure: PSA level in blood
timeFrame: 6 weeks post-operation
measure: PSA level in blood
timeFrame: 3 months post-operation
measure: PSA level in blood
timeFrame: 6 months post-operation
measure: PSA level in blood
timeFrame: 12 months post-operation
measure: local and regional recurrences on sonography
timeFrame: through study completion, an average of 1 year
measure: local and regional recurrences, on MRI
timeFrame: through study completion, an average of 1 year
measure: local and regional recurrences, on PET Scan
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
timeFrame: Preoperative
measure: Evaluating the pre and postoperative lower urinary tract symptoms using International Prostate Symptoms Scores (IPSS)
timeFrame: 3 months postoperative
measure: Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
timeFrame: 6 months, postoperative
measure: Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
timeFrame: 12 months postoperative.
measure: Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
timeFrame: Preoperative
measure: Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
timeFrame: 3 months, postoperative
measure: Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
timeFrame: 6 months, postoperative.
measure: Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
timeFrame: 12 months postoperative
measure: The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
timeFrame: Preoperative
measure: The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
timeFrame: 3 months, postoperative.
measure: The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
timeFrame: 6 months, postoperative
measure: The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
timeFrame: 12 months postoperative
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Binh Dan Hospital
Study officials:
affiliation: Binh Dan Hospital
name: Hung V Tran, MD, PhD
role: STUDY_DIRECTOR
References: