Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)
Recruiting · NCT06238713 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniquesSingle-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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\<8.
- 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;
- ECOG\>1.
- 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;
Where it is running
1 location listed.
- Changzheng hospital - Shanghai, Shanghai Municipality, China