GU-01: Glycyrrhizin in Prostate Cancer: A Window-of-Opportunity Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate anti-tumor activity of GLY by assessing changes in prostate-specific antigen (PSA) after GLY treatment administration and prior to radical prostatectomy
研究概览
简要总结
This is a pilot, randomized, window-of-opportunity treatment trial in which participants with previously untreated prostate cancer (PCa) who are candidates for surgery (radical prostatectomy)
详细描述
This is a pilot, randomized, window-of-opportunity treatment trial in which participants with previously untreated prostate cancer who are candidates for surgery (radical prostatectomy) will receive one cycle of therapy consisting of Glycyrrhizin (GLY) (Observation, Dose Level 1 75mg daily, or Dose Level 2, 150mg daily) for 5 weeks (+/- 2 weeks) prior to surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥ 18 years of age at time of consent
- •ECOG performance status of 0, 1, or 2
- •Histologic diagnosis of prostate cancer
- •Patient suitable for radical prostatectomy as determined by surgical team
- •Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.
- •Willing to use barrier contraceptive method during study intervention
排除标准
- •Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating urologic oncology team.
- •Previous chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents and/or investigational agents within 30 days of starting study treatment.
- •Potent or moderate inhibitors and inducers of CYP3A4 if taken within a 1 week wash-out period
- •Concomitant medications known to prolong QT interval, or with factors that increase the risk of QTc prolongation, or History of Torsades de Pointes. This may include patients who have sub-optimally controlled hypertension, serum potassium levels <4.0 mEq/L, serum magnesium ≤1.8 mg/dL, prolonged gastrointestinal transit time, or decreased 11-β-hydroxysteriod dehydrogenase-2 activity.
研究组 & 干预措施
Glycyrrhizin Arm 3 (Dose Level 2)
25 participants will be randomized to receive 150mg daily for 5 weeks (+/- 2 weeks)
干预措施: Glycyrrhizin - 150 mg (Drug)
Glycyrrhizin Arm 2 (Dose Level 1)
25 participants will be randomized to receive 75mg daily for 5 weeks (+/- 2 weeks)
干预措施: Glycyrrhizin - 75 mg (Drug)
Observational Arm 1 (Dose Level 0)
10 participants will be randomized to observational arm
干预措施: Observation (Other)
结局指标
主要结局
To evaluate anti-tumor activity of GLY by assessing changes in prostate-specific antigen (PSA) after GLY treatment administration and prior to radical prostatectomy
时间窗: 2 months
Changes in prostate specific antigen (PSA) in patients with prostate cancer will be assessed before and after administration of GLY
次要结局
- To evaluate the tolerability of GLY treatment administered daily prior to prostatectomy.(2 months)
- To assess of clinical laboratory and pathologic correlates in patients in relation to GLY treatment administration(2 months)
- To evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires(2 months)
研究者
Natalie Reizine
Principal Investigator
University of Illinois at Chicago