ACTRN12621000784819进行中（未招募）1 期
A feasibility study of the repurposing of prazosin to improve treatment outcomes in men receiving radiotherapy for prostate cancer (MiniRaP-00)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- GenesisCare
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •Histologically confirmed adenocarcinoma of the prostate
- •- Age greater or equal to 18 years
- •- Normal liver function: ALT <2x ULN, Bilirubin <1.5 x ULN or normal conjugated bilirubin
- •- Normal renal function: Serum urea and creatinine <1.5 ULN
- •- ECOG performance status of 0-1
- •- Participants capable of childbearing only if using adequate contraception
- •- Willingness to comply with all study procedures including IP administration protocol and required testing
- •- Signed, written and informed consent
- •- Participants are available for follow up
排除标准
- •- Evidence of >5 metastatic sites: Suspected or confirmed by appropriate imaging.
- •- Under the age of 18 years
- •- Presence of any medical, psychological or social condition that may hinder compliance
- •- Use of hormonal therapy more than 30 days prior to commencement of prazosin, other than ADT prescribed for the treatment of PCa
- •- History of any other previous malignancy within 5 years of the commencement of prazosin, other than successfully treated squamous cell or basal cell carcinoma of the skin
- •- Has received prior brachytherapy or radiotherapy for PCa to the same site
- •- Planned treatment with brachytherapy
- •- Planned treatment with stereotactic ablative body radiotherapy (SABR)
- •- Pre-existing hypotension defined as: Seated blood pressure < 100 mmHg systolic and/or < 70 mmHg diastolic
- •- Pre-existing orthostatic hypotension defined as: Decrease in systolic blood pressure of 20 mm Hg or a decrease in diastolic blood pressure of 10 mm Hg within three minutes of standing when compared with seated blood pressure
- •- Allergy to quinazolines
- •- Treatment with a1-antagonists with the last 6 months: Including all drugs within the class e.g. tamsulosin, silodosin, doxazosin, alfuzosin and prazosin
- •- Pre-existing cataract disease where cataract surgery is planned during the time that the patient would be receiving prazosin
- •- Patients are high falls risk as assessed by physician
- •- Planned cataract surgery
- •- Concurrent participation in other clinical trials or use of other investigational products
- •- Known gastrointestinal disease that could affect the absorption or tolerance of the IP
研究者
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