Randomized Phase II Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- AGE Level Reduction
研究概览
简要总结
The purpose of this study is to look at the effect that the study drug OPC has on AGE levels in patients with prostate cancer.
详细描述
AGEs are a type of metabolite, or substance, found in the food. The AGE content in food is determined by the types of food you eat and also how you prepare your food. The researchers helping conduct this study have found a potential link between AGE levels and cancer. The purpose of this study is to see if Oligomeric Procyanidin Complex (OPC) has an effect on the AGE levels in your blood and to see if those AGE levels have an effect on your cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Confirmation of adenocarcinoma of the prostate that is documented by one of the following: pathology report or clinic note with documented history of prostate cancer.
- •Subjects must be receiving ADT with a GnRH agonist or antagonist, with or without an anti-androgen, with a current testosterone level documented to be <50ng/dL at enrollment. Subjects whose ADT is interrupted may enroll or continue on study as long as the testosterone is documented to remain <50ng/dL for the entire duration of study participation. Subjects who have undergone orchiectomy are also eligible.
- •Prior cytotoxic chemotherapy for metastatic prostate cancer; prior treatment with genomically-targeted agents, or Provenge is allowed.
- •Subjects must have adequate hematologic, renal, and hepatic function at baseline, as follows:
- •Hematology parameters: ANC >1000/mcL, platelets > 100,000/mcL, Hgb >8.0gm/dL
- •Renal Function: eGFR of > 45mls/min using Cockgroft and Gault formula (see appendix C).
- •Liver Function: Total bilirubin ≤ULN, AST and ALT <1.5xULN
- •Able to swallow and retain oral medication
- •ECOG performance status of 0 - 2
- •Ability to sign written informed consent
- •Testosterone level <50ng/dL
排除标准
- •Known allergy to grapes or grape seed
- •History of receiving more than 2 classes of ADT.
- •Current use of strong antioxidants (extracts from grape seed, milk thistle; pine bark, green tea, saw palmetto; resveratrol; flavonoids; catechins; ellagic acid), large quantities of red grapes, white button mushrooms, red wine. See section 4.7 for more details.
研究组 & 干预措施
Metformin plus OPC
During week 1, subjects will take one metformin tablet in the morning and one OPC tablet in the morning and in the evening, about12 hours apart.
During weeks 2-12 the metformin tablet will betaken approximately 12 hours apart and one OPC about 12 hours apart, in the morning and in the evening.
干预措施: Metformin (Drug)
Metformin plus OPC
During week 1, subjects will take one metformin tablet in the morning and one OPC tablet in the morning and in the evening, about12 hours apart.
During weeks 2-12 the metformin tablet will betaken approximately 12 hours apart and one OPC about 12 hours apart, in the morning and in the evening.
干预措施: OPC (Other)
Metformin Only
Subjects will be supplied with metformin tablets850mg. During the ramp up phase subjects will take metformin in the morning. During weeks 2-12 the metformin tablet will be taken approximately 12 hours apart.
干预措施: Metformin (Drug)
OPC Only
Subjects will take one OPC capsule at the same time each morning and evening, approximately 12 hours apart during weeks 1-12.
干预措施: OPC (Other)
结局指标
主要结局
AGE Level Reduction
时间窗: 85 days
The primary objective is to determine if any of the test agent are able to reduce AGE levels by an average of 30% (or greater) in 50% or more of test subjects.
次要结局
- Correlation Between Changes to AGE Level and Changes to Insulin Resistance (HOMA-IR)(85 days)
- Correlation Between Changes to AGE Level and Changes to A1C.(85 days)
- Correlations Between Changes to AGE Level and Changes to Testosterone.(85 days)
- Correlation Between Changes to AGE Level and Changes to Lipids.(85 days)
- Correlation Between AGE Levels and Plasma IL6(85 days)
- Correlation Between AGE Levels and Leptin(85 days)
- Correlation Between AGE Levels and C-reactive Protein (CRP)(85 days)
- Correlation Between AGE Levels and Malondialdehyde (MDA)(85 days)
- Correlation Between AGE Levels and oxLDLs (Low Density Lipoprotein)(85 days)
- Correlation Between AGE Levels and sRAGE (Soluble Receptor for AGE)(85 days)
- Correlation Between Changes to AGE Level and Changes to PSA(85 days)
- Correlation Between Changes to AGE Level and Changes to BMI(85 days)
- Correlation Between Changes to AGE Level and Changes to Quality of Life(85 days)
- Frequency of Adverse Events as Assessed by CTCAE v. 4(85 days)
- Correlation Between Changes to AGE Level and Changes to Diet(85 days)