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Compares treatment options for Prostate Adenocarcinoma
Official title Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)
ClinicalTrials.gov ID: NCT06238713
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, men only
You may be able to join 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;
You likely can't join 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;
See the full eligibility criteria
- 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;
- 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...
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.