An Open, Single Dose, Antitumour Effect Study of 2-hydroxy-flutamide as a Controlled Release Product (Liproca Depot), Injected Into the Prostate in Patients With Localized Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Lidds AB
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Characterization and quantification of histopathological measurement of tumour tissue obtained from diagnostic biopsy.
研究概览
简要总结
The primary aim of the study was to characterize and quantify the histopathological changes in the surgical specimens obtained in patients undergoing prostatectomy in addition to imaging changes (MRI) following a single injection of Liproca Depot in patients with localized prostate cancer.
详细描述
The primary aim of the study was to characterize and quantify the histopathological changes in the surgical specimens obtained in patients undergoing prostatectomy in addition to imaging changes (MRI) following a single injection of Liproca Depot in patients with localized prostate cancer.
The secondary aims ere to evaluate efficacy and safety of a single injection of Liproca Depot, and to follow the pharmacokinetic profile.
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years, ≤ 75 years
- •Histologically confirmed localized (stage T1c, T2a-T2c) prostate cancer that is judged relevant for prostatectomy.
- •PSA value < 20 ng/ml within 6 weeks before enrolment.
- •Gleason score ≤ 3+4 at diagnostic biopsy (or preferably with more precise method for judging the localization of the primary tumour focus (foci).
- •Adequate renal function: Creatinine < 1.5 times upper limit of normal.
- •Adequate hepatic function: Aspartate Transaminase (ASAT), Alanine Transaminase (ALAT) and Alkalase Phosphatase (ALP) < 1.5 times upper limit of normal.
- •Negative dipstick for bacteriuria.
- •Patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit.
- •Patients that has been scheduled for prostatectomy
排除标准
- •Ongoing or previous hormone therapy for prostate cancer.
- •On-going or previous therapy within 12 month of finasteride or dutasteride.
- •On-going or previous invasive therapy for benign prostate hyperplasia (TURP, TUMT).
- •Use of pace maker or other electronic devices
- •Symptoms or signs of acute prostatitis.
- •Symptoms or signs of ulcered proctitis
- •Severe micturation symptoms
- •On-going therapy with anticoagulant (e.g Warfarin. Other anticoagulant should be withdrawn 1 week before injection).
- •Concomitant systemic treatment with corticosteroids, or immune modulating agents.
- •Known immunosuppressive disease (e.g. HIV, diabetes).
- •Simultaneous participation in any other study involving not market authorized drugs or having participated in a study within the last 12 months prior to start of study treatment.
研究组 & 干预措施
Liproca Depot
A parenteral controlled release depot formulation of 2-hydroxyflutamide (2-HOF) is given as a single dose injection into the prostate gland within the lobe area where the tumour tissue is localized.
干预措施: 2-hydroxyflutamide (2-HOF) (Drug)
结局指标
主要结局
Characterization and quantification of histopathological measurement of tumour tissue obtained from diagnostic biopsy.
时间窗: Day 1
The diffusion/flow of tissue water (ADC) before and after treatment assessed by diffusion-weighted imaging (MRI)
时间窗: Six weeks
Characterization and quantification of histopathological measurement of tumour tissue in surgical specimens obtained from patients undergoing prostatectomy
时间窗: Six weeks
次要结局
- Pharmacokinetics (Tmax and Cmax) of 2-hydroxyflutamide (2-HOF)(Six weeks)
- Number of participants with Adverse Events as a measure of Safety and Tolerability(Six weeks)
- Concentration of Choline, Creatinine and Citrate in tumour tissue before and after treatment(Six weeks)
- Total prostate volume by histopathology/MRI measúrements(Six weeks)
- Number of abnormal, clinically relevant, parameters from laboratory analyses(Six weeks)
- Concentration of Plasma Prostate Specific Antigen (PSA)(Six weeks)
- Surface fraction and volume of treated tumour focus (foci) based on MRI and histopathological map from surgical specimens at baseline and end of study, respectively(Six weeks)