Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Shanghai Changzheng Hospital
- Enrollment
- 480
- Locations
- 1
- Primary Endpoint
- Potency recovery rate
Study Overview
Brief Summary
This study is a two-arm, multicenter, randomized controlled clinical trial on whether single-port extraperitoneal VIP RARP is non-inferior to multi-port transperitoneal RARP in terms of functional recovery rate and other key metrics.
Detailed Description
Multicenter enrollment of 480 patients with localized prostate cancer meeting enrollment criteria are randomized to undergo either single-port robotic extraperitoneal VIP radical prostatectomy or multi-port robotic transperitoneal bilateral intrafascial radical prostatectomy for perioperative data recording, treatment, and monitoring with 1 year follow up.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men aged 18 years ≤ age ≤ 75 years;
- •Prostate biopsy within 6 months with diagnosis of organ-localized prostate cancer with preoperative staging of T1c to T2b,N0M0;.
- •Gleason Score<
- •PSA<20ng/ml.
- •Pathologic diagnosis of prostate follicular adenocarcinoma or prostate ductal adenocarcinoma;
- •The patient has healthy sexual function before surgery and intention for sexual activities after surgery;
- •Physiological condition acceptable for laparoscopic surgery;
- •Willing to cooperate and complete the study follow-up and related examinations;
- •The subject or his agent voluntarily participates in this trial and signs the written informed consent;
- •The questionnaire can be completed in Chinese.
- •The patient has been informed of the trial;
Exclusion Criteria
- •High-risk and non-organ localized prostate cancer (clinical stage ≥ T2c, GS ≥ 8, PSA > 20ng/ml);
- •Special type of prostate cancer， such as neuroendocrine etc.;
- •History of previous abdominal surgery and radiotherapy which may affect abdominal incision and Port placement;
- •Recent surgery of rectum, perianal abscess or around fistula and perineal area;
- •Patients who have undergone previous electro-prostatectomy/enucleation of the prostate;
- •Non-recurrent patients with less than 12 months of follow-up;
- •Combination of other systemic tumors;
- •had received any type of preoperative antitumor therapy;
- •Suffering from poor general condition with the presence of one of the following conditions: including severe mental disorders, cardiovascular disease, active infections, bone marrow transplantation within 3 months, or significant abnormalities in organ function;
- •Participation in other clinical studies or previous treatment with any gene therapy product within the last 3 months;
- •Other conditions that the researchers believe may affect the experimental results or are unethical;
Arms & Interventions
Multi-port transperitoneal RARP
Multi-port transperitoneal RARP with bilateral intrafascial nerve-sparing techniques
Intervention: Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques (Procedure)
Single-port extraperitoneal RARP
Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy (VIP) techniques
Intervention: Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques (Procedure)
Outcomes
Primary Outcomes
Potency recovery rate
Time Frame: 3 months after surgery
Potency recovery rate 3 months postoperatively, based on the patient's description of whether the erection is firm enough for sexual activity or intercourse.
Secondary Outcomes
- Continence recovery rate(Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively)
- Potency recovery rate(Up to 1 year, at a frequency of 1, 6, and 12 months postoperatively)
- Estimated blood loss(During operation（on an average of 90-120minutes ）)
- Number of additional ports(During operation（on an average of 90-120minutes ）)
- PSA(Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively)
- Period of hospitalization(During period of hospitalization (up to 7 days))
- Clavien-Dindo complication score(Every day during period of hospitalization (up to 7 days))
- Operative time(During operation（on an average of 90-120minutes ）)
- Period of hospitalization post surgery(Post surgery, during period of hospitalization (up to 7 days))
Investigators
Ren Shancheng
Professor，Chief of Urology
Shanghai Changzheng Hospital