A Prospective, Open-label, Exploratory Interventional Trial of Preoperative Semaglutide Prior to Radical Prostatectomy for Intermediate-risk Localized Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Caspase-3 (CC3) activation between baseline biopsy and radical prostatectomy specimen
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Caspase-3 (CC3) activation between baseline biopsy and radical prostatectomy specimen
时间窗: Baseline (pre-treatment biopsy) through radical prostatectomy, assessed up to 6 months
Measured via immunohistochemistry on prostate biopsy tissue and radical prostatectomy specimens; change assessed between pre-treatment biopsy and surgical specimen.
Change in Ki-67 proliferative index between baseline biopsy and radical prostatectomy specimen
时间窗: Baseline through radical prostatectomy, assessed up to 6 months
Percentage of Ki-67 expression measured via immunohistochemistry; compared between pre-treatment biopsy and radical prostatectomy specimen.
Change in Gleason score from biopsy to prostatectomy specimen
时间窗: Baseline biopsy through radical prostatectomy specimen collection, assessed up to 6 months
Pathologic Gleason Score assessed using the Gleason Grading System (score range 6-10). Higher scores indicate more aggressive prostate cancer pathology.
Change in Decipher genomic score in prostate tumor tissue
时间窗: Baseline biopsy through radical prostatectomy specimen collection, assessed up to 6 months
Decipher Genomic Classifier Score (continuous scale ranging from 0 to 1.0). Higher scores indicate greater risk of adverse oncologic outcomes.
次要结局
- Incidence of postoperative complications following radical prostatectomy assessed by Clavien-Dindo classification(30 days and 90 days following radical prostatectomy)
- Incidence of Grade 2 or higher adverse events as assessed by CTCAE criteria(From initiation of semaglutide through 90 days post-radical prostatectomy)
- Change in body weight(Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months)
- Change in body mass index (BMI)(Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months)
- Change in hemoglobin A1c (HbA1c)(Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months)
- Change in c-peptide levels(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)(Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months)
- Change in lipid profile parameters(Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months)