Phase IIa Study, Evaluating the Safety and Tolerability of Targeted Intraprostatic Administration of PRX302 With Histologically Proven,Clinically Significant Localised, Low to Intermediate Risk Prostate Cancer Associated With MRI Lesion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- safety and tolerability of a single injection of PRX302 in all patients will be assessed by recording Adverse Event assessments over 24 weeks
研究概览
简要总结
To Evaluate Safety, Tolerability and Potential Efficacy of PRX302 effect on clinically significant localised low to intermediate prostate cancer.
详细描述
A single center, open label, Phase IIa, Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) prospective development study. The study will treat approximately 20 men who meet the eligibility criteria, and give written informed consent. Safety and Tolerability will be assessed post-treatment at 2 days (phone call), 2 weeks, 6 weeks, 12 weeks, 24 weeks and 26 weeks. Potential Efficacy will be assessed by biopsy at 24 weeks and imaging (MRI) at 2 weeks, 12 weeks and 24 weeks and PSA outcomes at 12 and 24 weeks.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged ≥40 years and life expectancy of ≥10 years.
- •Serum prostate-specific antigen (PSA) ≤15 ng/mL.
- •Transperineal prostate biopsy within 12 months prior to dosing, with a clinically significant lesion correlating with an mpMRI visible lesion.
- •Radiological stage T1-T2 N0 Mx/M0 disease.
- •A visible lesion on mpMRI that is accessible to PRX302 transperineal injection.
排除标准
- •Previous radiation therapy to the pelvis.
- •Androgen suppression or anti-androgen therapy within the 12 months prior to dosing, for prostate cancer.
- •Use of a 5-alpha reductase inhibitor within the 3 months prior to dosing.
- •Evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging.
- •Inability to tolerate a transrectal ultrasound (TRUS).
- •Known allergy to latex or gadolinium (Gd).
- •Previous electroporation, radiofrequency ablation, high-intensity focused ultrasound (HIFU), cryosurgery, thermal or microwave therapy to treat cancer of the prostate.
- •Unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc. likely to contribute significant artifact to images).
研究组 & 干预措施
Intraprostatic administration
PRX302
干预措施: PRX302 (Drug)
结局指标
主要结局
safety and tolerability of a single injection of PRX302 in all patients will be assessed by recording Adverse Event assessments over 24 weeks
时间窗: Week 24
次要结局
- To evaluate the potential efficacy of PRX302 by • Transperineal targeted biopsy performed of the treated area at 24 weeks post-treatment(Week 24)