NCT06238713Recruiting
Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 480 (estimated)
- First submitted
- 15 Jan 2024
- Start date
- 8 Jan 2024
- Primary completion date
- Jun 2028
- Lead sponsor
- Shanghai Changzheng Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT06238713
What you commit to
- Study type: Interventional
- Planned participants: 480
- From 8 Jan 2024 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous abdominal surgery and radiotherapy which may affect abdominal incision and Port placement;
- Patients who have undergone previous electro-prostatectomy/enucleation of the prostate;
- had received any type of preoperative antitumor therapy;
- Participation in other clinical studies or previous treatment with any gene therapy product within the last 3 months;
Other illness
- 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.;
- Recent surgery of rectum, perianal abscess or around fistula and perineal area;
- 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;
- Other conditions that the researchers believe may affect the experimental results or are unethical;
Other
- Non-recurrent patients with less than 12 months of follow-up;
- ECOG\>1.
- Combination of other systemic tumors;
Who the study is looking for
- 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;
Age in the registry: 18 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Changzheng Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.