ISRCTN91422391已完成未知
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
Queen Mary University of London (UK)0 个研究点目标入组 130 人开始时间: 2014年4月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 130
研究概览
简要总结
2022 Results article in https://doi.org/10.1002/bco2.169 (added 08/07/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •Current inclusion criteria as of 10/12/2018:
- •1. Male subjects aged 16 years or over with an estimated life expectancy of more than three years
- •2. Willing and able to provide written informed consent
- •3. Corrected serum calcium <2.65 mmol/l
- •4. No previous treatment for prostate cancer (including surgery, hormone therapy, radiotherapy, cryotherapy)
- •5. All subjects must have had Magnetic Resonance Imaging (MRI) of the prostate with targeted biopsy of any lesions identified
- •6. Histologically confirmed prostate cancer* following prostate biopsy (including at least 10 cores of prostate tissue) in men opting for Active Surveillance as their primary cancer therapy
- •*PROVENT Prostate Cancer Criteria for Inclusion:
- •1. Gleason score 6 or 7 (Gleason 3+3 or 3+4)
- •2. Clinical and radiological stage 3. Serum PSA of 15.0 ng/ml or below
- •Less than 10 mm of cancer in a single core
- •7. Patients must have undergone a multi-parametric MRI deemed assessable by the local radiologist, and any lesions seen must have undergone targeted biopsy (transrectal or transperineal) within 12 months of study enrolment.
- •Previous inclusion criteria:
- •1. Male subjects aged 16 years or over with an estimated life expectancy of more than three years
- •2. Willing and able to provide written informed consent
- •3. Corrected serum calcium <2.65mmol/l
- •4. No previous treatment for prostate cancer (including surgery, hormone therapy, radiotherapy, cryotherapy)
- •5. All subjects must have had Magnetic Resonance Imaging (MRI) of the prostate with targeted biopsy of any lesions identified
- •6. Histologically confirmed prostate cancer* following prostate biopsy (including at least 10 cores of prostate tissue) in men opting for Active Surveillance as their primary cancer therapy
- •*PROVENT Prostate Cancer Criteria for Inclusion:
- •1. Gleason score 6 or 7
- •2. Clinical and radiological stage 3. Serum PSA of 15.0 ng/ml or below
- •Less than 10mm of cancer in a single core
- •7. Patients must have undergone a multi-parametric MRI deemed assessable by the local radiologist, and any lesions seen must have undergone targeted biopsy (transrectal or transperineal) within 12 months of study enrolment.
排除标准
- •Current exclusion criteria as of 10/12/2018:
- •1. Previously treated prostate cancer (including radiotherapy, hormone therapy, brachytherapy or surgery)
- •2. Current enrolment in an investigational drug, device or other clinical research study or participation in such a study within 30 days of randomisation
- •3. 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 Vitamin D within two years of study enrolment
- •4. Current or previous use of 5-alpha-reductase inhibitors such as finasteride or dutasteride
- •5. Not willing to comply with the procedural requirements of this protocol including repeat prostate biopsies
- •6. Known allergy/sensitivity to or intolerance of aspirin, other salicylates or NSAIDs e.g. ibuprofen/ naproxen
- •7. Prior history of gastro-intestinal bleeding or ulceration, severe dyspepsia or inflammatory bowel disease
- •8. Haemophilia or other bleeding diatheses
- •9. Prior history of renal stone disease
- •10. Chronic renal disease (= stage 4)
- •11. Known hypercalcaemia (corrected serum calcium >2.65 mmol/l) or untreated hyperparathyroidism
- •12. 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.
- •13. Any malignancy (other than non-melanoma skin cancer) that has not been in complete remission for five years
- •14. Any serious co-existent medical condition that would make repeat prostate biopsy hazardous e.g. anti-coagulation requiring continuous administration
- •15. Severe Asthma
- •16. G6PD deficiency
- •17. Pre-existing macular degeneration
- •18. All contraindications to aspirin and Vitamin D (e.g. Sarcoidosis), including concomitant therapy with any medication that may interact with aspirin or Vitamin D
- •19. Tuberculosis
- •20. Regular consumption of alcohol units greater than the recommended daily limit of 3-4 units per day (men)
- •Previous exclusion criteria:
- •1. Previously treated prostate cancer (including radiotherapy, hormone therapy, brachytherapy or surgery)
- •2. Current enrolment in an investigational drug, device or other clinical research study or participation in such a study within 30 days of randomisation
- •3. 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 Vitamin D within two years of study enrolment
- •4. Current or previous use of 5-alpha-reductase inhibitors such as finasteride or dutasteride
- •5. Not willing to comply with the procedural requirements of this protocol including repeat prostate biopsies
- •6. Known allergy/sensitivity to or intolerance of aspirin, other salicylates or NSAIDs e.g. ibuprofen/ naproxen
- •7. Prior history of gastro-intestinal bleeding or ulceration, severe dyspepsia or inflammatory bowel disease
研究者
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