NCT01020448已完成3 期
Prostate Cancer Antigen-3 (PCA-3) and TMPRSS2-ERG (T2-ERG) Score Changes During Initiation of Androgen Deprivation Therapy (ADT) With Triptorelin 22.5mg in Patients With Advanced Prostate Cancer (PCA): A Phase III, Single Arm Multicentre Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 339
- 试验地点
- 59
- 主要终点
- PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA
研究概览
简要总结
The purpose of this study is to evaluate the effect of an initial hormonal treatment gonadotrophin-releasing hormone (GnRH Agonist) on 2 biomarkers (PCA3 and TMPRSS2-ERG), in patients with histologically confirmed and advanced stages of prostate cancer. Their characteristics, according to risk factors such as PSA and Gleason score will be determined at baseline and 1, 3 and 6 month post-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
- Diagnostic
- 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
- •A histologically confirmed, locally advanced or metastatic prostate cancer, and naïve to androgen deprivation therapy, and a candidate for hormonal treatment.
- •An estimated survival time of at least twelve months according to the investigator's assessment.
- •A performance status score ≤ 2 according to the World Health Organisation (WHO) criteria.
排除标准
- •Previous surgical castration.
- •Previous or has planned curative prostate cancer therapy (radiation/surgery)
- •Previous hormone therapy (GnRH analogues, estrogens or anti-androgens)
- •Patients with risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or significant obstructive uropathy)
研究组 & 干预措施
Triptorelin (Decapeptyl®) 22.5 mg
Experimental
干预措施: Triptorelin (Decapeptyl®) (Drug)
结局指标
主要结局
PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA
时间窗: At month 6 post-treatment
PCA-3 score = (mRNA PCA3/mRNA PSA)x1000 * Non-assessable = Associated PSA mRNA \<7500 copies/mL * ≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA \>7500 copies/mL * \<35 = PCA-3 mRNA above BLQ and less than 35 * ≥35 = PCA-3 mRNA greater or equal to 35
次要结局
- PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA(At month 1 and 3 post-treatment)
- TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)(At baseline, month 1, 3 and 6 post-treatment)
- PSA Level(At baseline, month 1, 3 and 6 post-treatment)
- Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL)(At month 1, 3 and 6 post-treatment)
- Safety, Assessed Through the Collection of Adverse Events (AEs)(For the duration of the study (up to month 6))
研究者
研究点 (59)
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