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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Potency recovery rate [Time frame: 3 months after surgery]

Secondary outcome measures (9)

• Continence recovery rate [Time frame: Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively]
• PSA [Time frame: Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively]
• Potency recovery rate [Time frame: Up to 1 year, at a frequency of 1, 6, and 12 months postoperatively]
• Clavien-Dindo complication score [Time frame: Every day during period of hospitalization (up to 7 days)]
• Operative time [Time frame: During operation（on an average of 90-120minutes ）]
• Estimated blood loss [Time frame: During operation（on an average of 90-120minutes ）]
• Number of additional ports [Time frame: During operation（on an average of 90-120minutes ）]
• Period of hospitalization [Time frame: During period of hospitalization (up to 7 days)]
• Period of hospitalization post surgery [Time frame: Post surgery, during period of hospitalization (up to 7 days)]

Eligibility criteria

Inclusion criteria

• Men aged 18 years ≤ age ≤ 75 years;
• Prostate biopsy within 6 months with diagnosis of organ-localized prostate cancer with preoperative staging of T1c to T2b,N0M0;.
• Gleason Score<8.
• PSA<20ng/ml.
• Pathologic diagnosis of prostate follicular adenocarcinoma or prostate ductal adenocarcinoma;
• The patient has healthy sexual function before surgery and intention for sexual activities after surgery;
• Physiological condition acceptable for laparoscopic surgery;
• Willing to cooperate and complete the study follow-up and related examinations;
• The subject or his agent voluntarily participates in this trial and signs the written informed consent;
• The questionnaire can be completed in Chinese.
• The patient has been informed of the trial;

Exclusion criteria

• High-risk and non-organ localized prostate cancer (clinical stage ≥ T2c, GS ≥ 8, PSA > 20ng/ml);
• Special type of prostate cancer， such as neuroendocrine etc.;
• History of previous abdominal surgery and radiotherapy which may affect abdominal incision and Port placement;
• Recent surgery of rectum, perianal abscess or around fistula and perineal area;
• Patients who have undergone previous electro-prostatectomy/enucleation of the prostate;
• Non-recurrent patients with less than 12 months of follow-up;
• ECOG>1.
• Combination of other systemic tumors;
• had received any type of preoperative antitumor therapy;
• 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;
• Participation in other clinical studies or previous treatment with any gene therapy product within the last 3 months;
• Other conditions that the researchers believe may affect the experimental results or are unethical;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Changzheng hospital — Shanghai

Identifiers

NCT: NCT06238713 · SINO-TOP-23

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗