Phase II Trial of ArtemiCoffee for Men With Biochemical Recurrence of Prostate Cancer After Initial Local Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of patients who achieve a 50% decline in PSA levels
研究概览
简要总结
Until now, clinicians have been challenged to improve the treatment of biochemically recurrent (BCR) prostate cancer in which prostatic specific antigen (PSA) rises without radiological or clinical progression years after localized treatment (radical prostatectomy or radiation therapy) with or without hormonal treatment. Approximately 50-90% of men with high-risk prostate cancer will experience a BCR. Artesunate has demonstrated anti-tumor activity in both in vivo and in vitro cell lines. It is hypothesized that Artemisia annua (Aa) coffee has the potential to decrease rising PSA among patients with biochemical recurrence of prostate cancer.
详细描述
This is an open-labeled phase II study of Artemisia annua (Aa) decaf coffee in patients with biochemical recurrence of prostate cancer.
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
- •Completion of localized therapy (prostatectomy or radiotherapy) for prostate adenocarcinoma (either histologically or cytologically confirmed)
- •Biochemical PSA recurrence
- •Age ≥18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤3
- •Total bilirubin ≤ 1.5 x upper normal limit (ULN), and AST (aspartate transaminase) and ALT (alanine transaminase) ≤ 3.0 x ULN
- •Patients with a prior or concurrent malignancy (non-prostate) whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen as determined by the treating physician are eligible.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Any radiological evidence of metastatic disease (determined by standard of care computed tomography (CT) scans of abdomen, pelvis, chest, whole body bone scan or Axium PET/CT scan or prostate specific membrane antigen (PSMA) PET/CT scan).
- •Receipt of prior cytotoxic chemotherapy for recurrent prostate cancer
- •Use of androgen deprivation therapy (for example, bicalutamide, flutamide, nilutamide, or leuprolide acetate) concurrently or within the previous 3 months.
- •Uncontrolled intercurrent illness such as active infections. Other illnesses will be evaluated and eligibility status determined at the discretion of the treating physician and the investigator.
- •Psychiatric illness/social situations that would limit compliance with study requirements.
- •Concomitant use of nevirapine, ritonavir, and strong UGT inducers or strong UGT inhibitors such as phenobarbital, rifampin, carbamazepine, diclofenac, imatinib, axitinib, and vandetanib
- •Concurrent use of strong inducers of CYP2A6, including phenobarbital and rifampin
研究组 & 干预措施
Prostate cancer patients
Men with biochemical recurrence of prostate cancer after initial local therapy.
干预措施: ArtemiCoffee (Drug)
结局指标
主要结局
Proportion of patients who achieve a 50% decline in PSA levels
时间窗: 24 weeks
Proportion of patients who achieve greater than 50% decline in PSA within 24- weeks of coffee treatment.
次要结局
- Percentage change in serial PSA(24 weeks (Baseline, 3-mos, 6-mos and post-treatment))
- Percentage change in serial testosterone levels(24 weeks (Baseline, 3-mos, 6-mos and post-treatment))
- Change in PSA velocity and slope from pre-treatment to post-treatment(24 weeks (Baseline and 24 weeks))
研究者
Zin W Myint
Assistant Professor
University of Kentucky