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.
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<8.
PSA<20ng/ml.
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;
Parallel
Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques
Procedure/SurgeryPatients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up.
Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques
Procedure/SurgeryPatients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up.
Potency recovery rate
Potency recovery rate 3 months postoperatively, based on the patient's description of whether the erection is firm enough for sexual activity or intercourse.
Continence recovery rate
The rate of recovery of continence postoperatively, measured in the number of pads used per day.
PSA
PSA status postoperatively，measured in ng/mL
Potency recovery rate
Potency recovery rate will be assessed by patient's self-reported erectile firmness for sexual activity or intercourse, International Index of Erectile Dysfunction(IIEF-5) score（from 0-25 score, a higher score means a worse outcome）, and phosphodiesterase5 (PDE-5）inhibitor intake frequency according to patients' despciption (a higher intake means a worse outcome）.
Clavien-Dindo complication score
Clavien-Dindo complication score measured in the following grades（a higher grade means a worse outcome） ： First grade：complications that do not require medication, surgery or endoscopic treatment. Second grade： complications require to be treated with drugs, including blood transfusion and parenteral nutrition. Third grade： complications that require surgery, endoscopy, or radiation therapy. Fourth grade: the emergence of life-threatening complications, including cerebral hemorrhage, etc., which is also divided into 4a and 4b, 4a is single-organ dysfunction, 4b is mainly multi-organ dysfunction and injury. Fifth grade: death.
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Shanghai Changzheng Hospital
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
ShuGuang Hospital
Collaborator
Eastern Hepatobiliary Surgery Hospital
Collaborator
The First Affiliated Hospital of Guangzhou Medical University
Collaborator
Sir Run Run Shaw Hospital
Collaborator
Sichuan Provincial People's Hospital
Collaborator
