A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 8
- 主要终点
- Safety as measured by number and incidence of adverse events
研究概览
简要总结
Biolen, a novel implant, is intended to deliver an anti-androgen locally to the prostate gland for the management of prostate disease, while minimizing systemic exposure and its associated side-effects. The objectives of the study are to assess whether the Biolen is safe.
详细描述
This prospective, multi-center, single-arm feasibility study is planned to assess the safety and patient tolerance of Biolen for the localized delivery of bicalutamide into the prostate in patients presenting for treatment of prostate cancer. Study participants will have placement of the drug eluting Biolen and be followed through scheduled radical prostatectomy.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate.
- •Study participant qualified and planning for radical prostatectomy.
- •At least 1 prostate lesion measurable by MRI > 0.5 cm within one month of screening.
- •PSA > 3 ng/mL within 3 months of screening.
- •Gleason score 3+4 or higher.
- •Study participant must be willing to undergo post-treatment imaging by MRI.
- •ECOG performance status 0 or 1.
排除标准
- •Prior radiotherapy or surgery for prostate cancer.
- •Prior or ongoing hormonal therapy for prostate cancer.
- •Prior prostate procedures such as transurethral resection of the prostate, transurethral microwave thermotherapy of the prostate, high-intensity focused ultrasound or minimally invasive BPH procedure.
- •Study participant unwilling or unable to undergo MRI, including patients with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc.
- •Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images.
- •Use of 5 alpha reductase inhibitors (e.g. Finasteride or Dutasteride) within 3 months of screening or total use within the last two years prior to screening of > 3 months.
- •Presence of any metastatic disease.
- •Prostate volume more than 80 cc at prior MRI imaging.
- •I-PSS score >
- •History of prostate infection.
结局指标
主要结局
Safety as measured by number and incidence of adverse events
时间窗: change from baseline to radical prostatectomy up to 12 weeks after implantation
Adverse Events
次要结局
- change in prostate size(change from baseline to radical prostatectomy up to 12 weeks after implantation)
- change in Prostate Specific Antigen (PSA)(change from baseline to radical prostatectomy up to 12 weeks after implantation)
- change in tumor size(change from baseline to radical prostatectomy up to 12 weeks after implantation)