Comparing two robotic surgery methods for prostate cancer treatment

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

This study is testing which of two robotic surgery methods works better for treating localized prostate cancer and helps patients recover faster.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 480 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Male
• Sponsor: Shanghai Changzheng Hospital (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06238713 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multicenter, randomized controlled trial that aims to compare the effectiveness of single-port extraperitoneal robotic-assisted radical prostatectomy (RARP) versus multi-port transperitoneal RARP in treating localized prostate cancer. A total of 480 patients will be enrolled and randomly assigned to one of the two surgical approaches, with a focus on measuring functional recovery rates and other important outcomes. The study will monitor patients for one year post-surgery to gather comprehensive perioperative data and assess recovery metrics.

Who should consider this trial

Good fit: Ideal candidates for this study are men aged 18 to 75 with localized prostate cancer and healthy sexual function prior to surgery.

Not a fit: Patients with high-risk or non-organ localized prostate cancer, or those with specific types of prostate cancer, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into which surgical approach offers better functional recovery for patients undergoing prostate cancer surgery.

How similar studies have performed: Previous studies have shown promising results with robotic-assisted surgeries, but this specific comparison of single-port versus multi-port techniques is relatively novel.

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;

Where this trial is running

Shanghai, Shanghai Municipality

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

Study contacts

• Study coordinator: Shancheng Ren, MD/PhD

Conditions: Prostate Adenocarcinoma, Localized Prostate Carcinoma, Prostate Cancer, Robotic-assisted Radical Prostatectomy, da Vinci surgical robot, Potency, Non-inferiority, RCT