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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Potency recovery rate [Срок оценки: 3 months after surgery]

Вторичные конечные точки (9)

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

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Changzheng hospital — Шанхай

Идентификаторы

NCT: NCT06238713 · SINO-TOP-23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗