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Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)

RecruitingNAAges 18 Years - 75 YearsMaleShanghai Changzheng Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Men aged 18 years ≤ age ≤ 75 years; 2. Prostate biopsy within 6 months with diagnosis of organ-localized prostate cancer with preoperative staging of T1c to T2b,N0M0;. 3. Gleason Score\<8. 4. PSA\<20ng/ml. 5. Pathologic diagnosis of prostate follicular adenocarcinoma or prostate ductal adenocarcinoma; 6. The patient has healthy sexual function before surgery and intention for sexual activities after surgery; 7. Physiological condition acceptable for laparoscopic surgery; 8. Willing to cooperate and complete the study follow-up and related examinations; 9. The subject or his agent voluntarily participates in this trial and signs the written informed consent; 10. The questionnaire can be completed in Chinese. 11. The patient has been informed of the trial; Exclusion Criteria: 1. High-risk and non-organ localized prostate cancer (clinical stage ≥ T2c, GS ≥ 8, PSA \> 20ng/ml); 2. Special type of prostate cancer, such as neuroendocrine etc.; 3. History of previous abdominal surgery and radiotherapy which may affect abdominal incision and Port placement; 4. Recent surgery of rectum, perianal abscess or around fistula and perineal area; 5. Patients who have undergone previous electro-prostatectomy/enucleation of the prostate; 6. Non-recurrent patients with less than 12 months of follow-up; 7. ECOG\>1. 8. Combination of other systemic tumors; 9. had received any type of preoperative antitumor therapy; 10. 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; 11. Participation in other clinical studies or previous treatment with any gene therapy product within the last 3 months; 12. Other conditions that the researchers believe may affect the experimental results or are unethical;
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What it tests

  • Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy(VIP) techniques
  • Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques
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Where

1 site
Changzheng hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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