A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 413
- 试验地点
- 50
- 主要终点
- Co-primary endpoint 'A': Rate of absence of definite cancer using patients on active surveillance as a comparison.
研究概览
简要总结
The aims of this study are:
- to assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and
- to determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance (co-primary objective B).
详细描述
This is a Phase 3, multicentre, open label, randomised controlled study in subjects diagnosed with low risk prostate cancer on TransRectal Ultrasound (TRUS) guided biopsy.
Subjects will be randomised to either Active Surveillance or TOOKAD® Soluble VTP. Subjects will remain in the study for approximately 24 months following randomisation. A total of 400 subjects will be entered into the study; 200 will receive Active Surveillance and 200 will receive TOOKAD® Soluble-VTP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subjects will be eligible for inclusion in the study if all of the following criteria are met:
- •Low risk prostate cancer diagnosed using one transrectal ultrasound guided biopsy (TRUS)using from 10 to 24 cores performed less than 12 months prior to enrolment, and showing the following:
- •Gleason 3 + 3 prostate adenocarcinoma as a maximum,
- •Two (2) to three (3) cores positive for cancer
- •A maximum cancer core length of 5 mm in any core.
- •Cancer clinical stage up to T2a (pathological or radiological up to T2c disease permitted)
- •Serum prostate specific antigen (PSA) of 10 ng/mL or less
- •Prostate volume equal or greater than 25 cc and less than 70 cc.
- •Male subjects aged 18 years or older.
排除标准
- •Subjects will not be eligible for the study if meeting any of the following criteria:
- •Unwillingness to accept randomisation to either of the two arms of the study
- •Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy) or chemotherapy.
- •Any surgical intervention for benign prostatic hypertrophy
- •Life expectancy less than 10 years.
- •Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure.
- •Participation in another clinical study or recipient of an investigational product within 1 month of study entry.
- •Subject unable to understand the patient's information document, to give consent or complete the study tasks.
- •Subject in custody and or in residence in a nursing home or rehabilitation facility
- •Contra-indication to Magnetic resonance Imaging (MRI) (e.g., pacemaker, history of allergic reaction to gadolinium), or factors excluding accurate reading of pelvic MRI (e.g., hip prosthesis)
- •Any condition or history of illness or surgery that may pose an additional risk to men undergoing the TOOKAD® Soluble VTP procedure.
研究组 & 干预措施
TOOKAD® Soluble
TOOKAD® Soluble, lyophilized formulation, given at a dose of 4mg/Kg.
干预措施: TOOKAD® Soluble (Drug)
结局指标
主要结局
Co-primary endpoint 'A': Rate of absence of definite cancer using patients on active surveillance as a comparison.
时间窗: Month 24
Histological changes are assessed using biopsies or any other pathology result obtained during the study planned or not.
Co-primary endpoint 'B': Difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer.
时间窗: Over 24 months follow-up.
Moderate or higher risk is defined as the observation of: * More than 3 cores positive for cancer when considering all histological examination available during follow-up of study; * or any Gleason primary or secondary pattern 4 or more; * or at least one cancer core length greater than 5 mm; * or PSA\>10ng/mL ( in 3 consecutive measures); * or any T3 prostate cancer, * or metastasis; * or prostate cancer related death
次要结局
- The rate of additional prostate cancer radical therapy(Over 24 months follow-up)
- The rate of incontinence, erectile dysfunction, urinary symptoms(Randomisation visit, Day 7 after VTP , Month 3, Month 6, Month 9, Month 12, Month 24)
- The rate of adverse events(Screening-Month 24)
- Total number of cores positive for cancer(Month 24)
- The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death(Screening-Month 24)
- The overall quality of life will be recorded for potential utility and descriptive studies.(Randomisation visit; Month 12; Month 24)