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Trial Title:
Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)
NCT ID:
NCT06238713
Condition:
Prostate Adenocarcinoma
Localized Prostate Carcinoma
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate Cancer
Robotic-assisted Radical Prostatectomy
da Vinci surgical robot
Potency
Non-inferiority
RCT
Continence
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques
Description:
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.
Arm group label:
Single-port extraperitoneal RARP
Intervention type:
Procedure
Intervention name:
Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques
Description:
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.
Arm group label:
Multi-port transperitoneal RARP
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.
Detailed description:
Multicenter enrollment of 480 patients with localized prostate cancer meeting enrollment
criteria are randomized to undergo either single-port robotic extraperitoneal VIP radical
prostatectomy or multi-port robotic transperitoneal bilateral intrafascial radical
prostatectomy for perioperative data recording, treatment, and monitoring with 1 year
follow up.
Criteria for 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;
Gender:
Male
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Changzheng hospital
Address:
City:
Shanghai
Zip:
201109
Country:
China
Status:
Recruiting
Contact:
Last name:
Shancheng Ren, PhD
Phone:
13917793885
Email:
renshancheng@gmail.com
Start date:
January 8, 2024
Completion date:
December 2025
Lead sponsor:
Agency:
Shanghai Changzheng Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Collaborator:
Agency:
ShuGuang Hospital
Agency class:
Other
Collaborator:
Agency:
The Third Affiliated Hospital of Naval Medical University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Sir Run Run Shaw Hospital
Agency class:
Other
Collaborator:
Agency:
Sichuan Provincial People's Hospital
Agency class:
Other
Source:
Shanghai Changzheng Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06238713
