A Phase II Pharmacokinetic and Efficacy Study of Nordihydroguaiaretic Acid (NDGA) in Non-Metastatic Recurrent Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Prostate Specific Antigen (PSA) Response According to Consensus Criteria
研究概览
简要总结
This is a Phase II, single center study measuring the pharmacokinetic parameters of NDGA administration and assessing the proportion of patients who experience a 50% decline in PSA.
详细描述
This study is a phase II trial of NDGA in patients with hormone-sensitive non-metastatic prostate cancer with a pharmacokinetics component. The first six patients enrolled will be treated with a single 750 mg dose of oral NDGA on day -7 with measurement of pharmacokinetic parameters over eight hours after the dose, then begin treatment with 2000 mg of oral NDGA daily. Every four weeks, measurement of pharmacokinetic parameters at steady state will be done for all patients. All patients will continue dosing with NDGA and will be followed for PSA response and for safety. Measurement of pharmacokinetics for a 750 mg dose has been chosen to evaluate levels with the dosage that patients will be taking at one time point during the day (this is roughly one-third of the daily dose, which is administered in three divided doses).
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
- •Rising prostate-specific antigen (PSA) value after local therapy with a PSA doubling time (PSADT) between 6 and 24 months (four or more readings at least two weeks apart within the last six months)
- •Prior definitive therapy for prostate cancer consisting of one of the following:
- •External beam radiotherapy with or without hormone therapy
- •Brachytherapy with or without pelvic external beam radiation or hormone therapy
- •Radical prostatectomy with or without adjuvant or salvage radiation therapy
- •PSA > 1 ng/ml, which has risen serially on two determinations at least one week apart
- •Progressive disease by "Phoenix" consensus definition for patients who have undergone primary radiation therapy (PSA nadir + 2 ng/mL)
- •No metastatic disease
- •Prior adjuvant or neoadjuvant androgen deprivation is permitted, provided:
- •> 6 months since last day of effective androgen deprivation
- •Testosterone > 250 ng/dL
- •Patient is not on intermittent androgen deprivation
- •Karnofsky performance status (KPS) of > 70%
- •Liver Function Tests are within normal range
- •Glycated hemoglobin (HgA1c) < 6%
- •Patients must be four weeks from major surgery or radiotherapy to be eligible
排除标准
- •Presence of another active malignancy other than prostate cancer, or treated squamous/basal cell carcinoma of the skin. Concomitant medical condition which would make it undesirable, in the physician's opinion, for the patient to participate in the protocol or would jeopardize compliance with the protocol requirements
- •Diabetes mellitus, unless diet-controlled
- •Must be off saw palmetto, pomegranate juice, finasteride, or any herbal agent intended to lower PSA for > 4 weeks. Baseline PSADT calculation must occur off of these agents
- •Patients may not have evidence of local-only recurrence of prostate cancer
- •No history of liver disease, including Hepatitis B or C, alcoholic liver disease, or autoimmune liver disease. A prior history of Hepatitis A is allowed provided that baseline liver function tests are within normal limits
- •Patients with castration resistant prostate cancer are ineligible (prostate cancer which has progressed on androgen deprivation therapy with a Luteinizing hormone-releasing hormone (LHRH)-agonist or orchiectomy)
研究组 & 干预措施
1
干预措施: Nordihydroguaiaretic Acid (NDGA) (Drug)
结局指标
主要结局
Prostate Specific Antigen (PSA) Response According to Consensus Criteria
时间窗: Monthly, up to 29 months
Participants who experienced a PSA decline of at least 50%, confirmed by a second PSA value 4 or more weeks later. The reference PSA for decline was a PSA measured within 2 weeks of beginning study treatment. If at most 1 PSA response was observed among the first 12 patients, then accrual would stop and the trial would close for futility.
次要结局
未报告次要终点