NCT06238713 Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)
| NCT ID | NCT06238713 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Changzheng Hospital |
| Condition | Prostate Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2024-01-08 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 480 participants in total. It began in 2024-01-08 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06238713 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 75 Years, studying Prostate Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06238713 currently recruiting?
Yes, NCT06238713 is actively recruiting participants. Contact the research team at renshancheng@gmail.com for enrollment information.
Where is the NCT06238713 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06238713 clinical trial?
NCT06238713 is sponsored by Shanghai Changzheng Hospital. The trial plans to enroll 480 participants.