Evaluation of Cytotoxicity and Genetic Changes of High Dose Vitamin C Infusions in Castration Resistant Metastatic Human Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- PSA changes after 12-20 weeks of treatment
研究概览
简要总结
Can high dose, intravenous Vitamin C prolong life for patients with metastatic prostate cancer?
Prostate cancer is the most common cancer (excluding skin cancer) in men in Denmark and the Unites States. When metastatic disease is present cure is no longer possible. The main treatment at this stage is castration, either surgical or medical, ending the patients testosterone production and causing a temporary regression in disease activity.
Eventually, the cancer will progress, usually within 2 years from the castration, with a more aggressive course and a survival of 2-3 years.
The current treatment option for the patients, who have undergone castration and have disease progression, is chemotherapy with only limited gains in quality of life and survival.
This clinical study is a phase 2 study to evaluate the effects of high dose intravenous vitamin c in subjects with early castration resistant prostate cancer.
Primary endpoint:
- Prostate specific antigen (PSA) changes after 12 to 20 weekly vitamin c infusions
Secondary endpoints:
- Bone metastases changes after 12 to 20 weekly vitamin c infusions
- Changes in bone specific alkaline phosphates, oxidative DNA-damage, PINP, NTX after 12 to 20 weekly vitamin c infusions
- RNA-expression changes in prostatic tumor tissue after 12 to 20 weekly vitamin c infusions
- RNA-expression changes in lymphocytes after 12 to 20 weekly vitamin c infusions
Tertiary endpoints:
- Pharmacokinetics of vitamin c in the elderly cancer patients
Methods and material:
- 80 subjects are included (efficacy evaluation when 20 subjects have been evaluated for extension arm)
- Each subject receives a weekly infusion of 60 grams vitamin c (in the form of ascorbate) for 12 to 20 weeks
详细描述
Vitamin C for palliative treatment:
Intravenous vitamin C has been used since the 1970's for terminally ill cancer patients claiming big increases in survival time. The efficacy of the drug is questioned and no randomized, controlled trial of Vitamin C's efficacy on cancer patients survival has been made.
Recent results from in vitro and xenograft studies in mice has shown some promise for vitamin c as a cytotoxic agent against cancer cells.
The following parameters are recorded for baseline:
- Biomarkers (PSA, bALP, NTX, PINP)
- Routine blood work (hgb, creatinine, p-vitamin c etc.)
- Radio nucleotide bone scintigraphy
- Prostate biopsies for later microarray (Affymetrix ST1.0)
- Urine samples 8-oxo-guanine(for oxidative DNA-damage measurements)
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
- •Castration resistant metastatic prostate cancer (bony or visceral metastases)
- •Gleason sum > 6
- •PSA > 10 ng/ml
- •ECOG < 3
- •Prior orchidectomy or LHRH antagonist/agonist treatment
- •Must give informed content
排除标准
- •Synchronous active cancer (skin cancer excluded)
- •Prior chemotherapy
- •History of oxalate renal stones
- •Glucose-6-phosphate dehydrogenase deficiency
- •Impaired renal function (creatinine > 200micromoles/L
- •Haemochromatosis
- •Cardiac disease (NYHA > 2, CSS > 2, recent AMI (less than 6 months)
- •Recent major surgery (less than 4 weeks before inclusion and more than 2 days of admittance time)
- •Prior intended curative treatment of prostate cancer
研究组 & 干预措施
Vitamin C treatment
Each subjects receive 12 weeks of 1 weekly treatment with intravenous vitamin c.
5grams are given at week 1, 30 grams at week 2 and 60 grams at week 3-12. If eligibility criteria are met the subject may continue with 1 weekly vitamin c treatment of 60 grams at week 13-20.
干预措施: Ascorbic Acid (Vitamin C) (Drug)
结局指标
主要结局
PSA changes after 12-20 weeks of treatment
时间窗: 12, 20 and 26 weeks
次要结局
- Bone metastases changes(12, 26 and 52 weeks)
- bALP changes(12, 20, 26 and 52 weeks)
- NTX changes(12, 20, 26 and 52 weeks)
- PINP changes(12, 20, 26 and 52 weeks)
- 8-oxo-guanine changes(12 weeks)