Clinical trial NCT06238713: Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)
Official title: Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Adenocarcinoma
Localized Prostate Carcinoma
Keywords: Prostate Cancer
Robotic-assisted Radical Prostatectomy
da Vinci surgical robot
Potency
Non-inferiority
RCT
Continence
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: ShuGuang Hospital
name: The Third Affiliated Hospital of Naval Medical University
name: The First Affiliated Hospital of Guangzhou Medical University
name: Sir Run Run Shaw Hospital
name: Sichuan Provincial People's Hospital
First posted: 2024-02-02
Enrollment: 480
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Potency recovery rate
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Continence recovery rate
timeFrame: Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively
measure: PSA
timeFrame: Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively
measure: Potency recovery rate
timeFrame: Up to 1 year, at a frequency of 1, 6, and 12 months postoperatively
measure: Clavien-Dindo complication score
timeFrame: Every day during period of hospitalization (up to 7 days)
measure: Operative time
timeFrame: During operation（on an average of 90-120minutes ）
measure: Estimated blood loss
timeFrame: During operation（on an average of 90-120minutes ）
measure: Number of additional ports
timeFrame: During operation（on an average of 90-120minutes ）
measure: Period of hospitalization
timeFrame: During period of hospitalization (up to 7 days)
measure: Period of hospitalization post surgery
timeFrame: Post surgery, during period of hospitalization (up to 7 days)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changzheng hospital
state: Shanghai
Study officials:
References: