NCT01875393已完成3 期
Study of the Efficacy,Safety and Quality of Life After TOOKAD® Soluble Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Localized Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 3
- 主要终点
- To confirm that a significant proportion of patients will be prostate cancer free on the biopsy.
研究概览
简要总结
The aim of this study is to confirm the Efficacy,the Safety and the Quality of Life after TOOKAD® Soluble VTP in localized prostate cancer patients.
详细描述
The study is designed as a multicenter, single-arm, open label, 12 months follow-up clinical trial. Men with localized prostate cancer will be treated with TOOKAD® Soluble VTP under general anesthesia.
Patients will be followed-up for 12 months with patient questionnaires on QoL, erectile and urinary functions, clinical evaluation with study visits at 1, 3, 6 and 12 months , Prostate Specific Antigen(PSA) testing at 3, 6 and 12 months. In addition, they will have biopsy at 6 months (± 2) and 12 months.
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
- 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 carcinoma diagnosed using prostate biopsy showing:
- •Gleason 3+3 prostate
- •Gleason 3+4 prostate adenocarcinoma is acceptable provided it is not present in more than 2 cores and no more than 50% cancer in any core.
- •Clinical stage up to cT2a - N0/Nx - M0/Mx.
- •Serum prostate-specific antigen (PSA) ˂ 20ng/ml
- •Prostate volume ≥ 25 cc and ≤ 70 cc.
- •Male subjects aged 18 years or older.
- •Signed Informed Consent Form by the patient.
排除标准
- •Unwillingness to accept the treatment.
- •Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy)or chemotherapy.
- •Any surgical intervention for benign prostatic hypertrophy.
- •Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure.
- •Life expectancy less than 10 years.
- •Participation in another clinical study involving an investigational product within 1 month before study entry.
- •Subject unable to understand the patient's informed consent document, to give consent voluntarily or to complete the study tasks, especially unable to understand and fulfill the health-related QoL questionnaire.
- •Subject in custody and or in residence in a nursing home or rehabilitation facility.
- •Any condition or history of active rectal inflammatory bowel disease or other factors which may increase the risk of fistula formation;
- •Any hormonal manipulation (excluding 5-alpha-reductase inhibitors) that alters androgen production or use of androgen supplements within the previous 6 months;
- •Any history of urethral stricture disease;
- •Any history of acute urinary retention within 6 months of study entry
研究组 & 干预措施
TOOKAD® Soluble
Experimental
TOOKAD® Soluble, lyophilized formulation,given at a dose of 4 mg/kg.
干预措施: TOOKAD® Soluble (Drug)
结局指标
主要结局
To confirm that a significant proportion of patients will be prostate cancer free on the biopsy.
时间窗: Month 12
Number of patients with a negative biopsy.
次要结局
- Changes in urinary and erectile functions and their potential impact on quality of life using International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF) and the General quality of life (EQ5D) questionnaires.(Screening, 1, 3, 6 and 12 months after completing treatment)
- The rate of adverse events.(Screening-Month 12)
- The overall cancer burden in the prostate determined by biopsy as compared to baseline.(Month 12)
- The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death(Screening-Month 12)
研究者
研究点 (3)
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