Actively Recruiting
Extraperitoneal Single-port Robotic-assisted Radical Prostatectomy Versus Transperitoneal Multi-port RARP in Localized Prostate Cancer Treatment
Led by Shanghai Changzheng Hospital · Updated on 2024-08-05
480
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
S
Shanghai Changzheng Hospital
Lead Sponsor
S
Shanghai Zhongshan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter, randomized clinical trial to compare two types of robotic-assisted radical prostatectomy (RARP) for treating localized prostate cancer. The study aims to determine if single-port extraperitoneal VIP RARP is not worse than the multi-port transperitoneal RARP in terms of functional recovery and other important outcomes. This trial involves 480 male patients aged 18 to 75 with organ-localized prostate cancer and specific diagnostic criteria. Participants are randomly assigned to one of two groups: one receiving single-port extraperitoneal robotic-assisted radical prostatectomy using Vattikuti Institute Prostatectomy (VIP) techniques, and the other undergoing multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques. Both groups will be monitored for perioperative data and followed up for one year after surgery. During the study, researchers will assess outcomes such as potency recovery rate at 3 months and up to 1 year, continence recovery rate, PSA levels, complication scores during hospitalization, operative time, blood loss, number of additional ports used, and length of hospital stay. Follow-up evaluations occur at 1, 3, 6, and 12 months postoperatively to track recovery and safety. Participants will complete questionnaires in Chinese and cooperate with all study follow-ups and examinations.
CONDITIONS
Brief Title
Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged 18 to 75 years
- Diagnosis of organ-localized prostate cancer with clinical stage T1c to T2b, N0M0 within 6 months
- Gleason Score less than 8
- PSA level below 20 ng/ml
- Pathologic diagnosis of prostate follicular adenocarcinoma or prostate ductal adenocarcinoma
- Healthy sexual function before surgery and intention for sexual activity after surgery
- Physiological condition suitable for laparoscopic surgery
- Willingness to cooperate and complete study follow-up and examinations
- Ability to complete questionnaires in Chinese
- Voluntary participation with signed informed consent
- Patient has been informed about the trial
You will not qualify if you...
- High-risk or non-organ localized prostate cancer (clinical stage T2c or higher, Gleason Score 8 or above, PSA over 20 ng/ml)
- Special types of prostate cancer such as neuroendocrine
- History of abdominal surgery or radiotherapy affecting incision or port placement
- Recent surgery near rectum, perianal abscess, fistula, or perineal area
- Previous electro-prostatectomy or prostate enucleation
- Less than 12 months of follow-up for non-recurrent patients
- ECOG performance status greater than 1
- Combination with other systemic tumors
- Prior antitumor therapy before surgery
- Poor general condition including severe mental disorders, cardiovascular disease, active infections, recent bone marrow transplant, or significant organ dysfunction
- Participation in other clinical studies or gene therapy within the last 3 months
- Other conditions that may affect study results or are unethical
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants undergo either single-port extraperitoneal or multi-port transperitoneal robotic-assisted radical prostatectomy. They receive perioperative care including hospitalization lasting up to 7 days.
Hospitalization during this period
Duration - 1 year
Participants are monitored for recovery of continence and potency, PSA levels, and safety outcomes after surgery.
Visits at 1, 3, 6, and 12 months postoperatively
Trial Site Locations
Total: 1 location
1
Changzheng hospital
Shanghai, Shanghai Municipality, China, 201109
Actively Recruiting
Research Team
S
Shancheng Ren, MD/PhD
Y
Yi fan Chang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here