Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)

Not Applicable

Recruiting

• Conditions: Prostate Adenocarcinoma; Localized Prostate Carcinoma
• Interventions: Procedure: Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques; Procedure: Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques

• Registration Number: NCT06238713
• Lead Sponsor: Shanghai Changzheng Hospital

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.

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.

Study Timeline

• Study Start: 2024-01-08
• Study First Submitted: 2024-01-15
• Study First Submitted QC: 2024-02-01
• Study First Posted: 2024-02-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 480

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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
Multi-port transperitoneal RARP	Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques	Multi-port transperitoneal RARP with bilateral intrafascial nerve-sparing techniques

Primary Outcome Measures

Name	Time	Method
Potency recovery rate	3 months after surgery	Potency recovery rate 3 months postoperatively, based on the patient's description of whether the erection is firm enough for sexual activity or intercourse.

Secondary Outcome Measures

Name	Time	Method
Continence recovery rate	Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively	The rate of recovery of continence postoperatively, measured in the number of pads used per day.
Potency recovery rate	Up to 1 year, at a frequency of 1, 6, and 12 months postoperatively	Potency recovery rate will be assessed by patient's self-reported erectile firmness for sexual activity or intercourse, International Index of Erectile Dysfunction(IIEF-5) score（from 0-25 score, a higher score means a worse outcome）, and phosphodiesterase5 (PDE-5）inhibitor intake frequency according to patients' despciption (a higher intake means a worse outcome）.
Estimated blood loss	During operation（on an average of 90-120minutes ）	Estimated blood loss, measured in volume (mL)
Number of additional ports	During operation（on an average of 90-120minutes ）	Number of additional ports needed in surgery
PSA	Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively	PSA status postoperatively，measured in ng/mL
Period of hospitalization	During period of hospitalization (up to 7 days)	Hospital stay, counted in days from the first day of hospitalization to discharge
Clavien-Dindo complication score	Every day during period of hospitalization (up to 7 days)	Clavien-Dindo complication score measured in the following grades（a higher grade means a worse outcome） ： First grade：complications that do not require medication, surgery or endoscopic treatment.; Second grade： complications require to be treated with drugs, including blood transfusion and parenteral nutrition.; Third grade： complications that require surgery, endoscopy, or radiation therapy.; Fourth grade: the emergence of life-threatening complications, including cerebral hemorrhage, etc., which is also divided into 4a and 4b, 4a is single-organ dysfunction, 4b is mainly multi-organ dysfunction and injury.; Fifth grade: death.
Operative time	During operation（on an average of 90-120minutes ）	Time elapsed from skin incision to placement of the final skin suture, measured in minutes
Period of hospitalization post surgery	Post surgery, during period of hospitalization (up to 7 days)	Hospital stay, counted in days from the time of transfer to the post anesthesia care unit (PACU) to discharge

Trial Locations

Locations (1)

Changzheng hospital; 🇨🇳 Shanghai, Shanghai, China