The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy (CGMH-SPEAR-P)

The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy-a Single Arm Pivotal Trial Initiated by Chang Gung Memorial Hospital, Taiwan

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

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: da Vinci SP system

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).

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Po-Hung Lin, MD; Phone Number: +886975366240; Email: m7587@cgmh.org.tw
• Study Contact Backup: Name: Hung-Jen Wang, MD; Phone Number: +886975356239

Study Locations

• Taiwan
  • Taoyuan City, Taiwan, 333
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Po-Hung Lin; Phone Number: +886975366240; Email: m7587@cgmh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Patients with biopsy-proved prostate cancer
2. Stage clinical T1-T2N0M0
3. Prostate volume ≦ 70cm (by transrectal ultrasound or other image studies)
4. BMI ≦ 35 kg/m
5. Low priority of nerve sparing (pre-op sexual dysfunction or don't care about sexual function)
6. Age between 18 and 78 years old
7. Suitable for minimally invasive surgery
8. Patients willing and able to provide informed consent
9. Patients willing and able to comply with study protocol requirements and follow-up

Exclusion Criteria:

1. Previous abdominal or pelvic major operation history
2. Previous radiation treatment to the pelvic area
3. Patients received transurethral resection of prostate in three months

4. 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)
5. Anatomy unsuitable for endoscopic visualization or minimally invasive surgery
6. Hemodynamic or respiratory instability after anesthesia
7. Working space restriction (e.g. kyphosis or severe scoliosis)
8. Emergency surgery
9. Untreated active infection
10. vulnerable populations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study arm; Patients with prostate cancer	Device: da Vinci SP system; using da Vinci SP system to perform extraperitoneal approach radical prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	immediately after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative parameters-incision length (cm)	incision length	immediately after the surgery
Perioperative parameters-console time (minutes)	console time	immediately after the surgery
Perioperative parameters-blood loss (ml)	blood loss	immediately after the surgery
Perioperative parameters-blood transfusion type	blood transfusion type	immediately after the surgery
Perioperative parameters-blood transfusion unit	blood transfusion unit	immediately after the surgery
Perioperative parameters-intra-operative complications (SATAVA system)	intra-operative complications accessed with SATAVA system, Grade 1 to 3, higher grade indicates serious complications	immediately after the surgery
Perioperative parameters-oxidative stress	oxidative stress measured by the arterial malondialdehyde (MDA) level (micromole/L)	immediately after the surgery
Postoperative parameters-length of hospital stay (days)	length of hospital stay	immediately after discharge (assessed up to 10 days)
Postoperative parameters-pain scale (VAS score)	pain scale accessed with visual analog scale (VAS) score, 1-10, higher score indicates more pain	Every day during admission after the surgery (up to 7 days)
Postoperative parameters-analgesic type	analgesic type	Every day during admission after the surgery (up to 7 days)
Postoperative parameters-analgesic dose	analgesic dose	Every day during admission after the surgery (up to 7 days)
Postoperative parameters-postoperative complications (CLAVIEN-DINDO system)	postoperative complications accessed with CLAVIEN-DINDO system, Grade I to V, higher grade indicates severe complications	During admission after the surgery (up to 10 days)
Postoperative parameters-readmission and reoperation	Thirty-day readmission and reoperations in relation to the index procedure	If happens, on the day of re-admission or reoperations (up to 30 days)
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.	Post-operation 1/3/6/12 months
Functional outcomes-continence (pad amount)	pads used per day (for patients with incontinence)	Post-operation 1/3/6/12 months
Functional outcomes-continence (leak amount in gram)	24hr total weight of pads (for patients with incontinence)	Post-operation 1/3/6/12 months
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.	Baseline, Post-operation 1/3/6/12 months
Oncologic outcomes-margin status (positive or negative)	surgical margin status	when the pathology report is available (up to day 10)
Oncologic outcomes-biochemical recurrence	biochemical recurrence (PSA level ng/ml)	Post-operation 1/3/6/12 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: Intuitive Surgical
• Investigators: Principal Investigator: Chun-Te Wu, Professor, MD, PhD, Chang Gung Memorial Hospital at Keelung

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 30, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: prostate cancer; radical prostatectomy; da Vinci SP system; extraperitoneal approach
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 202101419A0C601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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