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Идёт набор NCT05155501

Clinical Trial of Approaches to Prostate Cancer Surgery

Без фазы С лечением Prostate Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Robot-assisted radical prostatectomy (RP), Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP).
Кому может быть актуально
Состояния в реестре: Prostate Cancer. Базовые параметры: 40 лет — 80 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Clinical TrIAL of Approaches to Prostate cAncer suRgery

Обзор

This is a prospective, randomized controlled trial to compare cancer control and health-related quality of life following pelvic fascia-sparing radical prostatectomy versus standard radical prostatectomy. The investigators hypothesize that pelvic fascia-sparing radical prostatectomy will have similar cancer control (primary outcome) and sexual function outcomes; and significantly better urinary function, penile shortening/deformity and inguinal hernia risks as compared to radical prostatectomy.

Подробное описание

Traditional radical prostatectomy is the most popular treatment for clinically significant prostate cancer, however significant risks including urinary incontinence, erectile dysfunction, penile shortening, penile curvature/ deformation (Peyronie's disease), and inguinal hernia, are common. Pelvic fascia-sparing radical prostatectomy is a new surgical technique that may preserve fascial support structures, arterial supply to the penis, and nerves that are severed and resected during conventional radical prostatectomy.

This study will enroll adult men undergoing radical prostatectomy for clinically localized prostate cancer. Subjects will be randomized to receive either radical prostatectomy or pelvic fascia-sparing radical prostatectomy. Investigators will compare cancer control and health-related quality of life outcomes through patient questionnaires and medical record review.

Вмешательства

  • Процедура Robot-assisted radical prostatectomy (RP)
    The conventional approach to prostate cancer surgery
  • Процедура Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)
    A novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate.

Первичные конечные точки

  • Surgical Margin Status as assessed by surgical pathology results [Срок оценки: 1 week post-surgery]
  • Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA) [Срок оценки: 6 months post-surgery]
  • Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA) [Срок оценки: 12 months post-surgery]
  • Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA) [Срок оценки: 24 months post-surgery]
Вторичные конечные точки (6)
  • Surgery-Related Adverse Events as assessed by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Срок оценки: Up to 30 days following surgery]
  • Change in Urinary and Sexual Function, as measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) [Срок оценки: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery]
  • Change in Patient-Reported Penile Shortening and Sexual Function, as measured by a 5-item questionnaire [Срок оценки: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery]
  • Change in patient-Reported Penile Curvature/Deformity (Peyronie's Disease), as measured by a 3-item questionnaire [Срок оценки: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery]
  • Patient-reported Decision Regret, as measured by a 5-item questionnaire [Срок оценки: 12 months post-surgery]
  • Patient-reported Decision Regret, as measured by a 5-item questionnaire [Срок оценки: 24 months post-surgery]

Критерии участия

Критерии включения

  • Male sex
  • Age ≥40 years or ≤80 years
  • Scheduled for radical prostatectomy for clinically localized prostate cancer
  • Able to read and speak English or Spanish
  • Willingness to sign informed consent and adhere to the study protocol

Критерии исключения

  • Prior major pelvic surgery or radiotherapy
  • Suspicion of N1 disease (i.e., any lymph node greater than 1cm in maximal diameter)

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
Простое слепое
Основная цель
Лечение

Центры проведения

США · 9 центров
  • Beckman Research Institute of City of Hope — Duarte
  • Georgetown University — Washington D.C.
  • Northwestern University — Chicago
  • Johns Hopkins University — Baltimore
  • Beth Israel Deaconess Medical Center (BIDMC) — Boston
  • Hackensack Meridian Health — Hackensack
  • NewYork-Presbyterian Queens — Flushing
  • Memorial Sloan Kettering Cancer Center — New York
  • … и ещё 1 центр

Публикации

  • Stangl-Kremser J, Kowalczyk K, Schaeffer EM, Allaf M, Scherr D, Yang X, Matoso A, Azumi N, Robinson B, Vickers A, Hu JC. Study protocol for a prospective, multi-centered randomized controlled trial comparing pelvic fascia-sparing radical prostatectomy with conventional robotic-assisted prostatectomy: The PARTIAL trial. Contemp Clin Trials. 2023 May;128:107168. doi: 10.1016/j.cct.2023.107168. Epub PMID 37015291

Идентификаторы

NCT: NCT05155501 · 21-07023781 · 1R01CA259173

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗