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

Prostate Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06238713
• Other study ID #: SINO-TOP-23
• Status: Recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Shanghai Changzheng Hospital
• Contact: Shancheng Ren, MD/PhD
• Phone: 139 1779 3885
• Email: renshancheng[@]gmai.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Changzheng hospital	Shanghai	Shanghai

Sponsors (7)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital	Shanghai Zhongshan Hospital, ShuGuang Hospital, Sichuan Provincial People's Hospital, Sir Run Run Shaw Hospital, The First Affiliated Hospital of Guangzhou Medical University, The Third Affiliated Hospital of Naval Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	PSA	PSA status postoperatively,measured in ng/mL	Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively
Secondary	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
Secondary	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)
Secondary	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 )
Secondary	Estimated blood loss	Estimated blood loss, measured in volume (mL)	During operation(on an average of 90-120minutes )
Secondary	Number of additional ports	Number of additional ports needed in surgery	During operation(on an average of 90-120minutes )
Secondary	Period of hospitalization	Hospital stay, counted in days from the first day of hospitalization to discharge	During period of hospitalization (up to 7 days)
Secondary	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)