prostate cancer
Conditions
Interventions
Test group:Unilateral intrafascial robot-assisted radical prostatectomy
Control group:Bilateral interfascial robot-assisted radical prostatectomy
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Men aged 18 to 80 years. 2.Newly diagnosed prostate adenocarcinoma confirmed pathologically by biopsy. 3.Clinically localized disease belonging to very low, low, or intermediate-risk group as per NCCN guidelines (2019 v4). 4.Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 5.Life expectancy greater than 10 years. 6.Patients who are well-informed of the current treatment options and are willing to participate in the trial. 7.Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1.Enlarged or bulky regional lymph node over 3 cm by preoperative imaging. 2.Bone or distant organ metastasis 3.Any contraindication for surgery 4.History of prior exposure to any treatment for prostate cancer, including but not limited to surgery, hormonal therapy, chemotherapy, radiotherapy, targeted therapy, and immunotherapy. 5.History of transurethral enucleation or resection of the prostate. 6.History of pelvic and lower abdominal surgery. 7.Any other previous or concurrent malignancies. 8.Disease complicated by other severe systemic diseases which, in the judgment of the investigators, are likely to interfere with the treatment, assessment or compliance associated with this trial. 9.Severe central nervous system diseases and/or mental disorders. 10.Participation in any other trial which is ongoing or has been completed within 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year biochemical recurrence-free survival rate;Pelvic floor muscle function (pelvic floor muscle ultrasound and pelvic floor electromyography); | — |
Secondary
| Measure | Time frame |
|---|---|
| Perioperative complications;Duration of postoperative in-hospital stay;Rate of positive surgical margin ;Intraoperative blood loss; pre-, per- and postoperative blood transfusion requirements;Patient-reported outcomes (PROs) on pain, urinary incontinence, bowel function and erectile function;atient-reported outcomes;In-hospital costs;prostate-cancer specific survival;overall survive; | — |
Countries
China
Contacts
Public ContactYicheng Chen
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed