Circulating Tumor DNA in High Risk Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- ctDNA detection
研究概览
简要总结
This prospective, non-therapeutic translational biomarker study will collect blood in patients with high risk localized prostate cancer prior to prostatectomy.
详细描述
The Vogelstein lab has developed a highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors. Plasma will be assayed for ctDNA using the SaferSeqS tumor-informed assay, employing DNA sequences derived from prostatectomy specimens. The abundance and molecular characteristics of ctDNA will be evaluated for a pilot group of 12-24 patients using an adaptive statistical design.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Must have histologically confirmed prostate cancer.
- •Age ≥ 18 years.
- •ECOG performance status of 0-
- •Must have the ability to understand and the willingness to sign a written informed consent document.
- •Willing to provide serial blood samples for the study.
- •Willing to provide tumor tissue (prostatectomy for primary cohort; prostatectomy or biopsy for exploratory cohort) for correlative studies which will compare ctDNA to tumor specimens.
- •Primary Cohort: High-risk localized prostate adenocarcinoma defined as one or more of the following:
- •o Clinical stage ≥ cT3a, Grade Group 4 or 5 (Gleason sum 8-10), and PSA ≥ 20
- •*Non-bulky pelvic lymphadenopathy and indeterminate findings on staging imaging (CT, bone scan, PSMA PET CT) are allowed if the surgeon believes RP is appropriate.
- •Exploratory Cohort: Men with a diagnosis of prostate adenocarcinoma and one of the following:
- •Localized prostate adenocarcinoma on active surveillance
- •Biochemically-recurrent prostate adenocarcinoma after definitive local therapy
- •Hormone-sensitive, metastatic prostate adenocarcinoma
- •Metastatic CRPC
排除标准
- •History of another primary cancer within the last 3 years, except for non-melanomatous skin cancer.
- •Receiving androgen deprivation or other systemic therapy for prostate cancer.
- •Medical condition or social situation that may preclude adherence to the protocol.
结局指标
主要结局
ctDNA detection
时间窗: Up to 2 years
Detection of ctDNA by assay in blood collected prior to radical prostatectomy using the Vogelstein lab assay. This assay is a highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors that has shown prognostic value for recurrence and predictive for benefit of adjuvant chemotherapy.
次要结局
- ctDNA abundance(Up to 2 years)
- serum PSA recurrence(At 12 months post-operative)
研究者
Leonard Appleman
Associate Professor of Medicine
University of Pittsburgh