Actively Recruiting
Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)
Led by Shanghai Changzheng Hospital · Updated on 2024-08-05
480
Participants Needed
1
Research Sites
99 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
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.
CONDITIONS
Official 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 within 6 months, clinical stage T1c to T2b, N0M0
- Gleason Score less than 8
- PSA less than 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
- Willing to cooperate and complete study follow-up and related examinations
- Voluntary participation with signed informed consent
- Ability to complete the questionnaire in Chinese
- Patient has been informed about the trial
You will not qualify if you...
- High-risk or non-organ localized prostate cancer (clinical stage ≥ T2c, Gleason Score ≥ 8, PSA > 20 ng/ml)
- Special types of prostate cancer such as neuroendocrine
- History of abdominal surgery or radiotherapy affecting abdominal incision or port placement
- Recent surgery near rectum, perianal abscess, fistula, or perineal area
- Prior electro-prostatectomy or prostate enucleation
- Follow-up less than 12 months in non-recurrent patients
- ECOG performance status greater than 1
- Presence of other systemic tumors
- Any preoperative antitumor therapy received
- Poor general health including severe mental disorders, cardiovascular disease, active infections, bone marrow transplant within 3 months, or significant organ function abnormalities
- Participation in other clinical studies or gene therapy within the last 3 months
- Other conditions that researchers believe may affect results or be unethical
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Changzheng hospital
Shanghai, Shanghai Municipality, China, 201109
Actively Recruiting
Research Team
S
Shancheng Ren, MD/PhD
CONTACT
Y
Yi fan Chang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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