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

Recruiting now · Not applicable

Conditions studied: Prostate Adenocarcinoma, Localized Prostate Carcinoma

In brief

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.

Key facts

Study ID

NCT06238713

Run by

Shanghai Changzheng Hospital

People needed

480

Starts

2024-01-08

Expected to finish

2028-12-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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

• Changzheng hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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