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

Last updated: August 2, 2024
Sponsor: Shanghai Changzheng Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques

Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy(VIP) techniques

Clinical Study ID

NCT06238713
SINO-TOP-23
  • Ages 18-75
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Men aged 18 years ≤ age ≤ 75 years;

  2. Prostate biopsy within 6 months with diagnosis of organ-localized prostate cancerwith preoperative staging of T1c to T2b,N0M0;.

  3. Gleason Score<8.

  4. PSA<20ng/ml.

  5. Pathologic diagnosis of prostate follicular adenocarcinoma or prostate ductaladenocarcinoma;

  6. The patient has healthy sexual function before surgery and intention for sexualactivities 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 thewritten informed consent;

  10. The questionnaire can be completed in Chinese.

  11. The patient has been informed of the trial;

Exclusion

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 abdominalincision 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 theprostate;

  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 followingconditions: including severe mental disorders, cardiovascular disease, activeinfections, bone marrow transplantation within 3 months, or significantabnormalities in organ function;

  11. Participation in other clinical studies or previous treatment with any gene therapyproduct within the last 3 months;

  12. Other conditions that the researchers believe may affect the experimental results orare unethical;

Study Design

Total Participants: 480
Treatment Group(s): 2
Primary Treatment: Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques
Phase:
Study Start date:
January 08, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Changzheng hospital

    Shanghai, Shanghai 201109
    China

    Active - Recruiting

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