Phase 2 Multicenter Prospective Open Label 2-Dose Level Clinical Safety and Efficacy Evaluation of Injection of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Undetectable cancer post-treatment in the region of the prostate where the baseline cancer was detected.
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of a single injection of NX-1207 for the treatment of biopsy-confirmed low risk localized (T1c) prostate cancer in patients currently undergoing active surveillance. Study participants currently on active surveillance will be randomized either to treatment with a single intraprostatic injection of NX-1207 (2.5 mg or 15 mg) followed by active surveillance or to no treatment (continued active surveillance). Blinded efficacy evaluation will be by a second post-treatment prostate biopsy.
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
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •T1c prostate cancer
- •Gleason score ≤ 6 with no Gleason pattern of 4 or
- •Life expectancy ≥ 5 years.
- •Single positive prostate biopsy core with ≤ 50% cancer
- •PSA ≤ 10 ng/mL
排除标准
- •Previous active treatment (such as surgery, brachytherapy, radiotherapy) for prostate cancer.
- •Evidence of metastatic disease or previous positive bone scan.
- •Previous hormonal therapy for prostate cancer.
- •Use of certain concomitant medications, including 5 alpha reductase inhibitors (e.g. finasteride, dutasteride), androgen receptor blockers (e.g. flutamide, bicalutamide), immunosuppressants(such as Imuran™, Enbrel™, Remicade™, Humira™, etc.), anticoagulants(such as Coumadin™ or heparin), or chemotherapeutics.
- •Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment within the past 12 months.
- •Pelvic irradiation.
- •Urinary tract infection more than once in the past 12 months.
- •Acute or chronic prostatitis in the past 12 months.
- •Clinically significant renal or hepatic impairment.
- •Bleeding disorder.
- •Poorly controlled diabetes type 1 or type
- •Urinary retention in the previous 12 months.
- •Self-catheterization for urinary retention.
- •Post-void residual urine volume > 200 mL.
- •Prior significant rectal surgery or any rectal condition with rectal stenosis or fistula.
- •History of alcohol or substance abuse or dependence within the past 2 years.
研究组 & 干预措施
NX-1207 2.5 mg
干预措施: NX-1207 2.5 mg (Drug)
NX-1207 15 mg
干预措施: NX-1207 15 mg (Drug)
结局指标
主要结局
Undetectable cancer post-treatment in the region of the prostate where the baseline cancer was detected.
时间窗: Baseline to 45 days post-treatment
The primary efficacy endpoint is the percentage of subjects with undetectable prostate cancer (negative biopsy) in the region of the prostate where the baseline cancer was detected.
Safety of a single treatment of NX-1207 2.5 mg or NX-1207 15 mg in subjects with biopsy-confirmed low grade low risk localized (T1c) prostate cancer.
时间窗: Baseline to 60 days post-treatment
Safety will be assessed by physical exam, prostate biopsy, monitoring of adverse events, changes in ECG, and changes in PSA and other clinical laboratory values.
次要结局
- Change in tumor grade in the region of the baseline prostate cancer(Baseline to 45 days post-treatment)
- Change in tumor volume in the region of the baseline prostate cancer(Baseline to 45 days post-treatment)
- Change in tumor grade for the whole prostate(Baseline to 45 days post-treatment)
- Change in tumor volume in the whole prostate(Baseline to 45 days post-treatment)