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临床试验/NCT03081481
NCT03081481已完成2 期

Multi-Centre, Ph IIb Study, Evaluating Safety & Efficacy of Targeted Intraprostatic Admin of PRX302 to Treat Men With Histologically Proven, Clinically Significant, Localised Prostate Cancer Associated With MRI Lesion

Sophiris Bio Corp8 个研究点 分布在 2 个国家目标入组 38 人开始时间: 2017年6月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
38
试验地点
8
主要终点
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

研究概览

简要总结

The purpose of this study is to determine a safe, effective, and tolerable dose of PRX302 for the treatment of low to intermediate risk prostate cancer.

详细描述

A multi-centre, open label, phase IIb study, evaluating the safety, tolerability and efficacy of a targeted intraprostatic focal administration in development. The study will treat approximately 40 men who meet the eligibility criteria, and give written consent. Safety and tolerability will be assessed post-treatment over 26 weeks. Efficacy will be assessed by biopsy and imaging (mpMRI) at 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

入选标准

  • Life expectancy ≥ 10 years.
  • Serum prostate-specific antigen (PSA) ≤ 15ng/mL.
  • A histologically proven, clinically significant lesion visible on mpMRI (magnetic resonance imaging) that is accessible to PRX302 transperineal injection.
  • Radiological stage T1-T2 N0 Mx/M0 disease.
  • Targeted prostate biopsy within 6 months prior to dosing, with a clinically significant lesion correlating with an mpMRI visible lesion.

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 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 transrectal ultrasound (TRUS).
  • Known allergy to latex or gadolinium (Gd).
  • Prior rectal surgery preventing insertion of the TRUS probe.
  • Any previous ablative procedures performed on the prostate, e.g., electroporation, radiofrequency ablation, high-intensity focused ultrasound (HIFU), cryosurgery, photochemical, 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

PRX302

Experimental

intraprostatic administration

干预措施: PRX302 (Drug)

结局指标

主要结局

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

时间窗: 26 weeks post administration

Treatment-emergent adverse events (TEAEs), including both serious and non-serious AEs, and assessments of severity and relatedness to both the study drug agent (PRX302) and the rest of the injection procedure

次要结局

  • Proportion of patients with an absence of clinically significant prostate cancer in the targeted area at 24 weeks post-administration of PRX302, as determined by a transperineal targeted biopsy [Efficacy](24 weeks post administration)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (8)

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