NCT00686088已完成2 期
An Open-Label, Multi-Center, Phase IIa Trial of PRX302 Treatment of Patients With Locally Recurrent Prostate Cancer After Primary Radiation Therapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- PSA levels, PSA doubling time, PSA velocity and tumor burden assessment by biopsy compared to screening.
研究概览
简要总结
The purpose of this study is to determine the therapeutic activity of different concentrations of PRX302 at increasing volumes and/or number of deposits per gram of prostate. Therapeutic activity will be determined based on changes in PSA levels, PSA velocity, PSA doubling time and tumor burden following treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Completed a full course of radiation therapy for prostate cancer at least 2 years before enrollment.
- •Biochemical failure at screening as determined by either the ASTRO or the Phoenix definitions.
- •At least 5 available PSA readings after completion of radiation therapy and prior to screening.
- •PSA level of not greater than 10 ng/mL.
- •PSA doubling time of at least 9 months at screening.
- •Biopsy-proven recurrent localized prostate cancer.
- •Tumor stage T1C to T2C.
- •Prostate volume estimated at 40 mL or less as determined by TRUS.
- •ECOG performance score 0 to
- •Serum testosterone of at least 1 ng/dL.
排除标准
- •Prior history of metastatic prostate cancer.
- •Salvage external beam therapy and/or salvage brachytherapy prior to enrollment.
- •Biological, immunological, chemotherapeutic treatment or cryotherapy after completing radiation.
- •Androgen ablation therapy within 12 months prior to enrollment.
- •Recurrence of prostate cancer within 18 months of definitive primary radiotherapy.
- •Other medication for prostate cancer.
- •Presence of active malignancy other than prostate cancer.
- •Treatment with other investigational therapies within 12 months prior to enrolment.
- •Presence of a chronic indwelling Foley catheter for obstructive uropathy.
- •Previous transurethral resection of the prostate (TURP), transurethral resection of the bladder neck, photo-selective vaporization of the prostate (PVP) or other resection surgery in the urinary tract.
- •Previous treatment with PRX
- •Any evidence of metastatic disease on bone scan, CT or magnetic resonance imaging (MRI) within 3 months prior to enrollment.
结局指标
主要结局
PSA levels, PSA doubling time, PSA velocity and tumor burden assessment by biopsy compared to screening.
时间窗: Day 45 and Day 180
次要结局
- Safety and tolerability of PRX302.(12 months.)
研究者
研究点 (4)
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