Phase II Study of Photodynamic Therapy With WST09 in Patients With Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure - Repeat Procedure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- STEBA France
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Prostate biopsy
研究概览
简要总结
This is a multi-centre, phase II, open-label, 12-month clinical trial for patients previously treated with WST09 (Tookad) who have positive prostate biopsies for cancer.
The study aims at delivering a second WST09 treatment for the purpose of eradicating the localized prostate cancer.
详细描述
Multi-centre, phase II, open-label, 12-month clinical trial for patients that previously received a vascular-targeted photodynamic treatment (VTP) with WST09 (Tookad) and still have histological findings (prostate biopsies) indicating the presence of localized cancer.
The WST09-mediated VTP procedure consists of an I.V. infusion of WST09 (Tookad) at 2 mg/kg, in combination with the per-cutaneous interstitial delivery of monochromatic laser light (of a wavelength of 763nm) via the trans-perineal implantation of illumination fibres, positioned in the prostatic lobes.
In a previous Tookad trial, escalating doses of laser light were used with a fixed dose of WST09 (2 mg/kg) in patients with localized prostatic cancer. Patients who underwent the procedure but still have positive prostate biopsies (residual cancer) may benefit from an additional WTS09-mediated VTP procedure. Thus, the aim of this study is to treat patients still presenting with localized prostate cancer with a second WST09-mediated VTP procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients previously treated with WST09-mediated VTP, with a positive biopsy of the prostate 6 months following treatment
- •Disease confined to the prostate
- •Life expectancy greater than 5 years
排除标准
- •Unwilling or unable to give informed consent
- •Patients who have received another treatment for their prostate cancer since their previous WST09-mediated VTP
研究组 & 干预措施
1
Treatment with Tookad VTP
干预措施: Treatment with Tookad VTP (Drug)
结局指标
主要结局
Prostate biopsy
时间窗: 12 months
次要结局
- MRI, PSA(7 days, 6 months)