Back to resultsThe Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy (CGMH-SPEAR-P)
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
da Vinci SP system
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, radical prostatectomy, da Vinci SP system, extraperitoneal approach
Eligibility Criteria
Inclusion Criteria:
- Patients with biopsy-proved prostate cancer
- Stage clinical T1-T2N0M0
- Prostate volume ≦ 70cm (by transrectal ultrasound or other image studies)
- BMI ≦ 35 kg/m
- Low priority of nerve sparing (pre-op sexual dysfunction or don't care about sexual function)
- Age between 18 and 78 years old
- Suitable for minimally invasive surgery
- Patients willing and able to provide informed consent
- Patients willing and able to comply with study protocol requirements and follow-up
Exclusion Criteria:
- Previous abdominal or pelvic major operation history
- Previous radiation treatment to the pelvic area
- Patients received transurethral resection of prostate in three months
Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions
- Severe heart disease (NYHA functional class III-IV)
- Severe lung disease (GOLD Group C-D)
- Anatomy unsuitable for endoscopic visualization or minimally invasive surgery
- Hemodynamic or respiratory instability after anesthesia
- Working space restriction (e.g. kyphosis or severe scoliosis)
- Emergency surgery
- Untreated active infection
- vulnerable populations
Sites / Locations
- Chang Gung Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study arm
Arm Description
Patients with prostate cancer
Outcomes
Primary Outcome Measures
Success rate (%)
Percentage of successful extraperitoneal approach radical prostatectomy with da Vinci SP system (no conversion to conventional laparoscopic, multiport da Vinci surgery or open surgery; addition of access port to complete the procedure would not be considered as conversion.)
Secondary Outcome Measures
Perioperative parameters-incision length (cm)
incision length
Perioperative parameters-console time (minutes)
console time
Perioperative parameters-blood loss (ml)
blood loss
Perioperative parameters-blood transfusion type
blood transfusion type
Perioperative parameters-blood transfusion unit
blood transfusion unit
Perioperative parameters-intra-operative complications (SATAVA system)
intra-operative complications accessed with SATAVA system, Grade 1 to 3, higher grade indicates serious complications
Perioperative parameters-oxidative stress
oxidative stress measured by the arterial malondialdehyde (MDA) level (micromole/L)
Postoperative parameters-length of hospital stay (days)
length of hospital stay
Postoperative parameters-pain scale (VAS score)
pain scale accessed with visual analog scale (VAS) score, 1-10, higher score indicates more pain
Postoperative parameters-analgesic type
analgesic type
Postoperative parameters-analgesic dose
analgesic dose
Postoperative parameters-postoperative complications (CLAVIEN-DINDO system)
postoperative complications accessed with CLAVIEN-DINDO system, Grade I to V, higher grade indicates severe complications
Postoperative parameters-readmission and reoperation
Thirty-day readmission and reoperations in relation to the index procedure
Functional outcomes-continence status
Continence status after Foley catheter removed. Pad-free or one safe pad used are defined as continence intact. More than one pad used is defined as post-operative incontinence.
Functional outcomes-continence (pad amount)
pads used per day (for patients with incontinence)
Functional outcomes-continence (leak amount in gram)
24hr total weight of pads (for patients with incontinence)
Functional outcomes-sexual function change (IIEF-5)
sexual function at baseline and 1/3/6/12 months with International Index of Erectile Function (IIEF-5), 0-25, higher score indicates better sexual function.
Oncologic outcomes-margin status (positive or negative)
surgical margin status
Oncologic outcomes-biochemical recurrence
biochemical recurrence (PSA level ng/ml)
Full Information
NCT ID
NCT05403190
First Posted
May 18, 2022
Last Updated
February 21, 2023
Sponsor
Chang Gung Memorial Hospital
Collaborators
Intuitive Surgical
1. Study Identification
Unique Protocol Identification Number
NCT05403190
Brief Title
The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy
Acronym
CGMH-SPEAR-P
Official Title
The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy-a Single Arm Pivotal Trial Initiated by Chang Gung Memorial Hospital, Taiwan
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Intuitive Surgical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to evaluate the performance and safety of da Vinci Single Port (SP) system on the surgery for extraperitoneal approach radical prostatectomy
Detailed Description
Enrolled subjects would receive extraperitoneal approach radical prostatectomy using da Vinci SP system and be assessed at baseline (preoperatively), during hospitalization, and postoperatively (at 1 month +/-4 days, 3 month +/- 7 days, 6 months +/- 10 days, 12month +/-14 days). The preoperative assessment includes any diagnostic tests to confirm the subjects' cancer status and eligibility for the intervention under consideration such as transrectal or transperineal biopsy, image studies for staging including MRI/CT and bone scan, and cardiopulmonary tests to evaluate risks for anesthesia. The hospitalization assessment includes the collection of perioperative and postoperative details, conversions, and complications. The postoperative assessment includes regular follow up studies to evaluate cancer status and functional outcome (For sexual function, the International Index of Erectile Function (IIEF-5) would be recorded before and after the surgery. For continence, the number of pads per day and 24hr total weight of pads would be recorded. No pad used or one safe pad per day with net wet ≤ 50gm would be considered as continent. International Prostate Symptom Score (IPSS) wound be recorded before and after the surgery to access voiding function).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, radical prostatectomy, da Vinci SP system, extraperitoneal approach
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study arm
Arm Type
Experimental
Arm Description
Patients with prostate cancer
Intervention Type
Device
Intervention Name(s)
da Vinci SP system
Intervention Description
using da Vinci SP system to perform extraperitoneal approach radical prostatectomy
Primary Outcome Measure Information:
Title
Success rate (%)
Description
Percentage of successful extraperitoneal approach radical prostatectomy with da Vinci SP system (no conversion to conventional laparoscopic, multiport da Vinci surgery or open surgery; addition of access port to complete the procedure would not be considered as conversion.)
Time Frame
immediately after the surgery
Secondary Outcome Measure Information:
Title
Perioperative parameters-incision length (cm)
Description
incision length
Time Frame
immediately after the surgery
Title
Perioperative parameters-console time (minutes)
Description
console time
Time Frame
immediately after the surgery
Title
Perioperative parameters-blood loss (ml)
Description
blood loss
Time Frame
immediately after the surgery
Title
Perioperative parameters-blood transfusion type
Description
blood transfusion type
Time Frame
immediately after the surgery
Title
Perioperative parameters-blood transfusion unit
Description
blood transfusion unit
Time Frame
immediately after the surgery
Title
Perioperative parameters-intra-operative complications (SATAVA system)
Description
intra-operative complications accessed with SATAVA system, Grade 1 to 3, higher grade indicates serious complications
Time Frame
immediately after the surgery
Title
Perioperative parameters-oxidative stress
Description
oxidative stress measured by the arterial malondialdehyde (MDA) level (micromole/L)
Time Frame
immediately after the surgery
Title
Postoperative parameters-length of hospital stay (days)
Description
length of hospital stay
Time Frame
immediately after discharge (assessed up to 10 days)
Title
Postoperative parameters-pain scale (VAS score)
Description
pain scale accessed with visual analog scale (VAS) score, 1-10, higher score indicates more pain
Time Frame
Every day during admission after the surgery (up to 7 days)
Title
Postoperative parameters-analgesic type
Description
analgesic type
Time Frame
Every day during admission after the surgery (up to 7 days)
Title
Postoperative parameters-analgesic dose
Description
analgesic dose
Time Frame
Every day during admission after the surgery (up to 7 days)
Title
Postoperative parameters-postoperative complications (CLAVIEN-DINDO system)
Description
postoperative complications accessed with CLAVIEN-DINDO system, Grade I to V, higher grade indicates severe complications
Time Frame
During admission after the surgery (up to 10 days)
Title
Postoperative parameters-readmission and reoperation
Description
Thirty-day readmission and reoperations in relation to the index procedure
Time Frame
If happens, on the day of re-admission or reoperations (up to 30 days)
Title
Functional outcomes-continence status
Description
Continence status after Foley catheter removed. Pad-free or one safe pad used are defined as continence intact. More than one pad used is defined as post-operative incontinence.
Time Frame
Post-operation 1/3/6/12 months
Title
Functional outcomes-continence (pad amount)
Description
pads used per day (for patients with incontinence)
Time Frame
Post-operation 1/3/6/12 months
Title
Functional outcomes-continence (leak amount in gram)
Description
24hr total weight of pads (for patients with incontinence)
Time Frame
Post-operation 1/3/6/12 months
Title
Functional outcomes-sexual function change (IIEF-5)
Description
sexual function at baseline and 1/3/6/12 months with International Index of Erectile Function (IIEF-5), 0-25, higher score indicates better sexual function.
Time Frame
Baseline, Post-operation 1/3/6/12 months
Title
Oncologic outcomes-margin status (positive or negative)
Description
surgical margin status
Time Frame
when the pathology report is available (up to day 10)
Title
Oncologic outcomes-biochemical recurrence
Description
biochemical recurrence (PSA level ng/ml)
Time Frame
Post-operation 1/3/6/12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with biopsy-proved prostate cancer
Stage clinical T1-T2N0M0
Prostate volume ≦ 70cm (by transrectal ultrasound or other image studies)
BMI ≦ 35 kg/m
Low priority of nerve sparing (pre-op sexual dysfunction or don't care about sexual function)
Age between 18 and 78 years old
Suitable for minimally invasive surgery
Patients willing and able to provide informed consent
Patients willing and able to comply with study protocol requirements and follow-up
Exclusion Criteria:
Previous abdominal or pelvic major operation history
Previous radiation treatment to the pelvic area
Patients received transurethral resection of prostate in three months
Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions
Severe heart disease (NYHA functional class III-IV)
Severe lung disease (GOLD Group C-D)
Anatomy unsuitable for endoscopic visualization or minimally invasive surgery
Hemodynamic or respiratory instability after anesthesia
Working space restriction (e.g. kyphosis or severe scoliosis)
Emergency surgery
Untreated active infection
vulnerable populations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Po-Hung Lin, MD
Phone
+886975366240
Email
m7587@cgmh.org.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Hung-Jen Wang, MD
Phone
+886975356239
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Te Wu, Professor, MD, PhD
Organizational Affiliation
Chang Gung Memorial Hospital at Keelung
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Po-Hung Lin
Phone
+886975366240
Email
m7587@cgmh.org.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy
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