An Open, Single and Multiple Dose, Efficacy and Safety Proof of Principle Study of Liproca Depot, a Controlled Release Formulation of 2-hydroxyflutamide, Injected Into the Prostate in Patients With Localized Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Lidds AB
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Proportion of Patients Showing PSA Nadir
研究概览
简要总结
The primary objective was to evaluate efficacy of a single dose of Liproca Depot in patients with localized prostate cancer. Primary efficacy variable was the proportion of patients showing PSA nadir. 24 Caucasian men, with a mean age at inclusion of 68.4 years, with localized prostate cancer were injected once with a ready made paste including 600 mg 2-hydroxyflutamide (Liproca Depot) into the site of the prostate where the tumour was localized. The patient was monitored for prostate-specific antigen (PSA) for maximum 6 months or to progression within this time period. The primary endpoint showed interesting results with high success rate (83%), i.e. proportion of patients (Responders) that reached plasma PSA nadir.
详细描述
Patients with localized prostate cancer were followed to progression or maximum 24 weeks after a single injection in one lobe of 2-8 mL ready-made paste (corresponding to 400-1600 mg 2-Hydroxyflutamid). Progression was defined as an increase in PSA by > 25% over baseline or on-treatment nadir.Among the 24 patients the primary endpoint, plasma PSA nadir, was reached by 20 patients (Responders). Efficacy was measured primarily as PSA nadir, and secondly as time to PSA nadir and prostate volume change. Safety was monitored throughout the whole study period.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 45years
- •Histologically confirmed localized prostate cancer (T1-T2), predominantly in one side of the peripheral zone, verified by biopsy.
- •PSA value < 20 ng/ml within 6 weeks before enrolment.
- •Gleason score ≤ 3+4 at diagnostic biopsy
- •Adequate renal function: Creatinine < 1.5 times upper limit of normal.
- •Adequate hepatic function: ASAT, ALAT and ALP < 1.5 times upper limit of normal.
- •Negative dipstick for bacturia.
- •Patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit.
排除标准
- •Previous or ongoing hormone therapy for prostate cancer.
- •Ongoing or previous therapy (within3 month) of finasteride or dutasteride.
- •Ongoing or previous invasive therapy for benign prostate hyperplasia (TURP, TUMT).
- •Symptoms or signs of acute prostatitis.
- •Symptoms or signs of ulceric proctitis
- •Severe micturation symptoms (I-PSS >17)
- •Concomitant systemic treatment with corticosteroids, or immunomodulating agents.
- •Known immunosuppressive disease (e.g. HIV, insulin dependent 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
2-Hydroxyflutamide
Single injection of 2-Hydroxyflutamide (2-8mL ready-made paste)in one prostate lobe
干预措施: 2-hydroxyflutamide (2-HOF) [Liproca Depot] (Drug)
2-Hydroxyflutamide
Single injection of 2-Hydroxyflutamide (2-8mL ready-made paste)in one prostate lobe
干预措施: 2-Hydroxyflutamide (Drug)
结局指标
主要结局
Proportion of Patients Showing PSA Nadir
时间窗: Measured every 4th week until progression or maximum 6 months.
Plasma PSA nadir is the lowest PSA reading achieved after any treatment for prostate cancer. The patients were observed once every 4th week during the study period.
次要结局
- Time to PSA Nadir(Measured every 4th week until progression or maximum 6 moths.)
- Number of Days to Prostate Volume Nadir.(Measured every 4th week until progression or maximum 6 months.)
- Number of Patients Reporting Adverse Events Caused by the Study Treatment(Measured every 4th week till progression or maximum 6 months)
- Percent Change in Prostate Volume From Baseline to Nadir.(Measured every 4th week until progression or maximum 6 months.)
- Percent Change in Prostate Volume From Baseline to Final Visit(Measured every 4th week until progresion or maximum 6 months.)