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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Adenocarcinoma; Localized Prostate Carcinoma
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shancheng Ren, MD/PhD; Phone Number: 139 1779 3885; Email: renshancheng@gmai.com
• Study Contact Backup: Name: Yi fan Chang; Phone Number: 13661652533; Email: 13661652533@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201109
      • Recruiting
      • Changzheng hospital
      • Contact: Shancheng Ren, PhD; Phone Number: 13917793885; Email: renshancheng@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-port extraperitoneal RARP; Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy (VIP) techniques	Procedure: 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.
Active Comparator: Multi-port transperitoneal RARP; Multi-port transperitoneal RARP with bilateral intrafascial nerve-sparing techniques	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continence recovery rate	The rate of recovery of continence postoperatively, measured in the number of pads used per day.	Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively
PSA	PSA status postoperatively，measured in ng/mL	Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively
Potency recovery rate	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）.	Up to 1 year, at a frequency of 1, 6, and 12 months postoperatively
Clavien-Dindo complication score	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.	Every day during period of hospitalization (up to 7 days)
Operative time	Time elapsed from skin incision to placement of the final skin suture, measured in minutes	During operation（on an average of 90-120minutes ）
Estimated blood loss	Estimated blood loss, measured in volume (mL)	During operation（on an average of 90-120minutes ）
Number of additional ports	Number of additional ports needed in surgery	During operation（on an average of 90-120minutes ）
Period of hospitalization	Hospital stay, counted in days from the first day of hospitalization to discharge	During period of hospitalization (up to 7 days)
Period of hospitalization post surgery	Hospital stay, counted in days from the time of transfer to the post anesthesia care unit (PACU) to discharge	Post surgery, during period of hospitalization (up to 7 days)

Collaborators and Investigators

• Sponsor: Shanghai Changzheng Hospital
• Collaborators: Shanghai Zhongshan Hospital; The First Affiliated Hospital of Guangzhou Medical University; Sir Run Run Shaw Hospital; Sichuan Provincial People's Hospital; ShuGuang Hospital; The Third Affiliated Hospital of Naval Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Prostate Cancer; RCT; Non-inferiority; Continence; Potency; da Vinci surgical robot; Robotic-assisted Radical Prostatectomy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: SINO-TOP-23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No