PROVENT: A Randomised, Double Blind, Placebo Controlled Feasibility Study to Examine the Clinical Effectiveness of Aspirin and/or Vitamin D3 to Prevent Disease Progression in Men on Active Surveillance for Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 7
- 主要终点
- Rate of Patient Recruitment to a Randomised Chemoprevention Study in Men Enrolled on an Active Surveillance Programme for Prostate Cancer. Number Accrued Per Month.
研究概览
简要总结
To demonstrate the acceptability and feasibility of recruitment to a randomised chemoprevention study of standard (300mg) or low dose (100mg) aspirin vs. placebo and/or Vitamin D3 vs. placebo in patients enrolled on an Active Surveillance programme for prostate cancer.
详细描述
The PROVENT study is a randomised, double blind, placebo controlled feasibility study to examine the clinical effectiveness of aspirin and/or Vitamin D3 to prevent disease progression in men on Active Surveillance for prostate cancer
The main outcome measure of the trial is the rate of patient recruitment to a randomised chemoprevention study in men enrolled on an Active Surveillance programme for prostate cancer
Secondary outcomes include the response to treatment as determined by serial multi-parametric magnetic resonance imaging (MRI) of the prostate, biochemical disease progression and histological disease progression after 12 months of therapy and finally toxicity and/or allergy to both aspirin and Vitamin D3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Previously treated prostate cancer (including radiotherapy, hormone therapy, brachytherapy or surgery)
- •Currently enrolled, or has been a participant within the last 30 days, in any other investigational drug or device study.
- •Current daily use of aspirin or NSAIDs; or daily dietary supplements/medication containing more than 400 IU (10 micrograms per day) Vitamin D; or chronic use (defined as > 6 months continuous daily use) of either aspirin or >400IU Vitamin D within two years of study enrolment
- •Current or previous use of 5-α reductase inhibitors such as finasteride or dutasteride
- •Not willing to comply with the procedural requirements of this protocol including repeat prostate biopsies
- •Known allergy/sensitivity to or intolerance of aspirin, other salicylates or NSAIDs e.g. ibuprofen/ naproxen
- •Prior history of gastro-intestinal bleeding or ulceration, severe dyspepsia or inflammatory bowel disease
- •Haemophilia or other bleeding diatheses
- •Prior history of renal stone disease
- •Chronic renal disease (≥stage 4)
- •Known hypercalcaemia (corrected serum calcium >2.65 mmol/l) or untreated hyperparathyroidism
- •Any bowel condition that would make repeat transrectal biopsy hazardous or difficult to perform e.g. recto-urethral fistula, or prior bowel surgery such as abdomino-perineal resection.
- •Any malignancy (other than non-melanoma skin cancer) that has not been in complete remission for five years
- •Any serious co-existent medical condition that would make repeat prostate biopsy hazardous e.g. anti-coagulation requiring continuous administration
- •Severe Asthma
- •G6PD ( glucose-6-phosphate dehydrogenase) deficiency
- •Pre-existing macular degeneration
- •All contraindications to aspirin and Vitamin D3 (e.g. Sarcoidosis), including concomitant therapy with any medication that may interact with aspirin or Vitamin D3 (see section 4.10)
- •Tuberculosis
- •Regular consumption of alcohol units greater than the recommended daily limit of 3-4 units per day (men)
研究组 & 干预措施
High dose Aspirin & Vitamin D
Aspirin high dose (300mgs) daily & Vitamin D 4,000 IU (0.1mg) per day
干预措施: High dose Aspirin & Vitamin D (Drug)
High dose Aspirin, Vitamin D placebo
high dose aspirin (300mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
干预措施: High dose Aspirin, Vitamin D placebo (Drug)
High dose Aspirin, Vitamin D placebo
high dose aspirin (300mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
干预措施: Aspirin placebo, Vitamin D placebo (Drug)
Low dose Aspirin , Vitamin D
Low dose aspirin (100mgs) daily & Vitamin D 4,000 IU (0.1mg) per day
干预措施: Low dose Aspirin , Vitamin D (Drug)
Low dose Aspirin, Vitamin D placebo
Low dose aspirin (100mgs) daily and Vitamin D placebo (Miglyol®812 Oil)
干预措施: Low dose Aspirin, Vitamin D placebo (Drug)
Aspirin Placebo, Vitamin D
Aspirin placebo and Vitamin D active ingredient - Vigantol® Oil
干预措施: Low dose Aspirin , Vitamin D (Drug)
Aspirin Placebo, Vitamin D
Aspirin placebo and Vitamin D active ingredient - Vigantol® Oil
干预措施: Aspirin Placebo, Vitamin D (Drug)
Aspirin placebo, Vitamin D placebo
Aspirin placebo and Vitamin D placebo - Miglyol®812 Oil
干预措施: Aspirin placebo, Vitamin D placebo (Drug)
结局指标
主要结局
Rate of Patient Recruitment to a Randomised Chemoprevention Study in Men Enrolled on an Active Surveillance Programme for Prostate Cancer. Number Accrued Per Month.
时间窗: 12 months
The proportion of eligible patients that join the trial over the 12-month trial recruitment period.
次要结局
- Number of Participants With Biochemical (PSA) Disease Progression(12 months)
- Number of Participants With Histological Disease Progression(3 years)
- Response to Treatment as Determined by Serial Multi-parametric Magnetic Resonance Imaging (MRI) of the Prostate. New Lesion Present or Existing Lesion + or - in Size.(3 years)
- Number of Patients With Adverse With Toxicity, Allergy or Symptoms From Aspirin or Vitamin D(18 months + 30 days)