Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)
1 other identifier
interventional
480
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 8, 2024
CompletedFirst Submitted
Initial submission to the registry
January 15, 2024
CompletedFirst Posted
Study publicly available on registry
February 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedAugust 5, 2024
August 1, 2024
1.4 years
January 15, 2024
August 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Potency recovery rate
Potency recovery rate 3 months postoperatively, based on the patient's description of whether the erection is firm enough for sexual activity or intercourse.
3 months after surgery
Secondary Outcomes (9)
Continence recovery rate
Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively
PSA
Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively
Potency recovery rate
Up to 1 year, at a frequency of 1, 6, and 12 months postoperatively
Clavien-Dindo complication score
Every day during period of hospitalization (up to 7 days)
Operative time
During operation（on an average of 90-120minutes ）
- +4 more secondary outcomes
Study Arms (2)
Single-port extraperitoneal RARP
EXPERIMENTALSingle-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy (VIP) techniques
Multi-port transperitoneal RARP
ACTIVE COMPARATORMulti-port transperitoneal RARP with bilateral intrafascial nerve-sparing techniques
Interventions
Patients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up.
Patients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up.
Eligibility Criteria
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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Changzheng Hospitallead
- Shanghai Zhongshan Hospitalcollaborator
- ShuGuang Hospitalcollaborator
- Eastern Hepatobiliary Surgery Hospitalcollaborator
- The First Affiliated Hospital of Guangzhou Medical Universitycollaborator
- Sir Run Run Shaw Hospitalcollaborator
- Sichuan Provincial People's Hospitalcollaborator
Study Sites (1)
Changzheng hospital
Shanghai, Shanghai Municipality, 201109, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor，Chief of Urology
Study Record Dates
First Submitted
January 15, 2024
First Posted
February 2, 2024
Study Start
January 8, 2024
Primary Completion
June 1, 2025
Study Completion
December 1, 2025
Last Updated
August 5, 2024
Record last verified: 2024-08