Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)
NCT ID: NCT06238713
Last Updated: 2024-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
480 participants
INTERVENTIONAL
2024-01-08
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Single-port extraperitoneal RARP
Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy (VIP) techniques
Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques
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.
Multi-port transperitoneal RARP
Multi-port transperitoneal RARP with bilateral intrafascial nerve-sparing techniques
Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques
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.
Interventions
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Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques
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.
Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques
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
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Inclusion Criteria
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
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;
18 Years
75 Years
MALE
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
ShuGuang Hospital
OTHER
The Third Affiliated Hospital of Naval Medical University
UNKNOWN
The First Affiliated Hospital of Guangzhou Medical University
OTHER
Sir Run Run Shaw Hospital
OTHER
Sichuan Provincial People's Hospital
OTHER
Shanghai Changzheng Hospital
OTHER
Responsible Party
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Ren Shancheng
Professor，Chief of Urology
Locations
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Changzheng hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SINO-TOP-23
Identifier Type: -
Identifier Source: org_study_id
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