Study of Photodynamic Therapy With WST09 in Patients With Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- STEBA France
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Prostate biopsy results at Month 6 after treatment.
研究概览
简要总结
The aim of this clinical trial is to evaluate the efficacy and safety of the WST09-mediated vascular-targeted photodynamic therapy (VTP) in patients with localized prostate cancer recurrent after external radiation therapy or temporary (High Dose Rate, or HDR) brachytherapy.
详细描述
This is a multicentre, open labelled, phase II/III, 6-month clinical trial with an additional follow-up at Month 12, aiming to determine the efficacy and tolerability of the WST09-mediated VTP treatment. This treatment consists of an I.V. infusion of WST09 (2 mg/kg), in combination with per-cutaneous interstitial illumination using laser light (wavelength at 763nm) delivered through optical fibres positioned through the perineum in the prostatic lobes.
Patients who are eligible to participate in the study must have a clinically diagnosed positive biopsy of the prostate (up to stage T2b-N0-M0) diagnosed after external radiotherapy or temporary brachytherapy (no seeds), and present with increasing PSA levels on three consecutive occasions (at least 3 months apart) post-radiation treatment.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically proven localized prostate cancer after receiving external radiation therapy;
排除标准
- •Patients unwilling or unable to give informed consent; Patients who received or are receiving chemotherapy; Patients previously treated with HIFU, cryotherapy, other salvage treatments, or with a trans-urethral resection of the prostate (TURP); Patients whose previous radiation therapy caused extensive cystitis and/or proctitis.
- •Patients suspected of Disseminated Intravascular Coagulation (DIC). Patients with prior history of coronary artery disease, angina pectoris, myocardial infarction, coronary angioplasty or coronary artery bypass graft, severe valvulopathy, cardiac failure, artrial fibrillation and / or sustained arrhythmia.
- •Patients whose cardiac status does not allow general anesthesia. Patients with history of thromboses or thrombo-embolisms. Patients with history of stroke or transient ischemic attack.
研究组 & 干预措施
WST 09
Treatment with WST09-mediated VTP
干预措施: Treatment with WST09 Vascular Photodynamic therapy (Drug)
结局指标
主要结局
Prostate biopsy results at Month 6 after treatment.
时间窗: 6 months
次要结局
- Percentage of positive cores in the biopsies prior to and 6 months after the WST09-mediated VTP.(6 months)
- PSA levels taken periodically for 1 year after the procedure(Month 1,3,6 and 1 year)
- Hypoperfusion according to MRI at Week 1 after the procedure.(1 week and Month 6)
- Calculated PSA velocity before and after WST09-mediated VTP.(Month 1,3,6 and 1 year)
- Nadir of the PSA after the WST09-mediated VTP compared with the nadir of PSA after radiation therapy(Month 1,3,6 and 1 year)
- To assess the safety and tolerability of WST09-mediated VTP treatment in this patient population(Day1,Day 7, Month1,3,6,and 12)