An "Old" Biomarker That Can Learn New Tricks: Prognostic Role of Free Psa Ratio at Biochemical Recurrence After Radical Treatments for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 822
- 试验地点
- 1
- 主要终点
- Metastasis free survival
研究概览
简要总结
Measurement of Free PSA ratio in patients after definitive radical treatment for prostate cancer, and assessment of whether post-treatment free PSA ratio can function as a biomarker for advanced disease in prostate cancer patients.
详细描述
Prostatic specific antigen (PSA) circulates mostly in complex with protease inhibitors, but 10-30% circulates as inactive free-PSA (FPSA). In patients with prostate cancer (PCa), pretreatment FPSA is lower and used to risk-stratify patients for biopsy. However, posttreatment FPSA ratio (FPSAR) is rarely quantified, with an unexplored clinical value.
Methods The institutional database was queried to identify patients following radical prostatectomy (RP cohort) or radiotherapy (RT cohort) between 2000 and 2017. For validation, the investigators identified an independent prospective cohort with biochemical recurrence (BCR) after RP, using biobank samples (biobank cohort). All patients had at least one posttreatment FPSAR test. Kaplan-Meier (KM) method was used to compare the metastasis-free (MFS), castration-resistant PCa (CRPC)-free, and cancer-specific-survival (CSS) rates. Multivariable Cox models determined the association between posttreatment FPSAR, metastases, and CRPC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •For the two retrospective cohorts:
- •All patients that older than 18 treated for localized adenocarcinoma of the prostate between 2000 and 2017 with either radical prostatectomy or radiotherapy
- •All treated patients had a rising post-treatment PSA, with at least one post-treatment free PSA blood test.
- •For the biobank validation cohort:
- •All patients treated with radical prostatectomy for localized prostate cancer between 2000 and 2017 who had biobank samples taken when developing biochemical recurrence.
排除标准
- •Patients that were younger than 18,
- •Patients with prostate cancer other than adenocarcinoma, such as small cell and neuroendocrine cancer
- •Patients with prostate adenocarcinoma that did not develop biochemical recurrence.
- •In the retrospective cohorts - patients that did not have at least one post-treatment free PSA blood test.
结局指标
主要结局
Metastasis free survival
时间窗: From date of diagnosis to date of Metastasis development, assessed up to 200 months
Rate of Metastasis correlated to the first post-treatment free PSA ratio
次要结局
- Cancer specific survival(From date of diagnosis to date of cancer specific death, assessed up to 200 months)
- Castrate resistant prostate cancer (CRPC) free survival(From date of Diagnosis to date of CRPC development, assessed up to 200 months)
研究者
Hanan Goldberg
Principal Investigator
University of Toronto