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Набор скоро начнётся NCT07727473

Preoperative Semaglutide Prior to Radical Prostatectomy

Ранняя фаза I 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: Semaglutide 2.4 mg.
Кому может быть актуально
Состояния в реестре: Prostate Cancer. Базовые параметры: от 18 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
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Официальное название

A Prospective, Open-label, Exploratory Interventional Trial of Preoperative Semaglutide Prior to Radical Prostatectomy for Intermediate-risk Localized Prostate Cancer

Обзор

In this exploratory, single-arm, nonrandomized trial, the impact of the preoperative utilization of the glucagon-like peptide-1 (GLP-1) receptor agonist (RA) semaglutide prior to radical prostatectomy in participants with intermediate risk prostate cancer will be investigated. Semaglutide will be administered according to the FDA-approved label for chronic weight management and participants will be dosed with a weekly subcutaneous injection. The primary aim of this trial is to explore the tumor biological activity of semaglutide in these participants. The trial will also evaluate the safety and tolerability of this preoperative treatment, along with the impact on physiologic/metabolic parameters.

Вмешательства

  • Препарат Semaglutide 2.4 mg
    Semaglutide will be administered as a weekly subcutaneous injection. The dose will be titrated according to the FDA-approved labeling, starting at 0.25 mg once weekly and increasing as tolerated to a target maintenance dose of up to 2.4 mg once weekly. Treatment will continue for 3 to 6 months prior to planned radical prostatectomy.

Первичные конечные точки

  • Change in Caspase-3 (CC3) activation between baseline biopsy and radical prostatectomy specimen [Срок оценки: Baseline (pre-treatment biopsy) through radical prostatectomy, assessed up to 6 months]
  • Change in Ki-67 proliferative index between baseline biopsy and radical prostatectomy specimen [Срок оценки: Baseline through radical prostatectomy, assessed up to 6 months]
  • Change in Gleason score from biopsy to prostatectomy specimen [Срок оценки: Baseline biopsy through radical prostatectomy specimen collection, assessed up to 6 months]
  • Change in Decipher genomic score in prostate tumor tissue [Срок оценки: Baseline biopsy through radical prostatectomy specimen collection, assessed up to 6 months]
Вторичные конечные точки (8)
  • Incidence of postoperative complications following radical prostatectomy assessed by Clavien-Dindo classification [Срок оценки: 30 days and 90 days following radical prostatectomy]
  • Incidence of Grade 2 or higher adverse events as assessed by CTCAE criteria [Срок оценки: From initiation of semaglutide through 90 days post-radical prostatectomy]
  • Change in body weight [Срок оценки: Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months]
  • Change in body mass index (BMI) [Срок оценки: Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months]
  • Change in hemoglobin A1c (HbA1c) [Срок оценки: Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months]
  • Change in c-peptide levels [Срок оценки: Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months]
  • Change in high-sensitivity C-reactive protein (hsCRP) [Срок оценки: Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months]
  • Change in lipid profile parameters [Срок оценки: Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months]

Критерии участия

Критерии включения

  • Male participants aged ≥18 years
  • Biopsy-proven intermediate-risk localized prostate cancer per NCCN risk stratification criteria
  • Planning to undergo radical prostatectomy, and surgical delay of 3-6 months is deemed appropriate by the investigator
  • Body mass index (BMI) >35 kg/m²
  • No prior exposure to androgen deprivation therapy or androgen receptor pathway inhibitors

Критерии исключения

  • Prostate cancer risk classification other than intermediate risk
  • Hemoglobin A1c (HbA1c) >9%
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
  • Baseline gastroparesis, dysphagia, or other significant gastrointestinal disease limiting oral intake
  • Current or recent (within 12 months) exposure to GLP-1 receptor agonist therapy
  • Delay of radical prostatectomy by 3-6 months is not deemed advisable by the investigator

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Banner MD Anderson Cancer Center at Gateway — Gilbert

Идентификаторы

NCT: NCT07727473 · 2241-2114

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗