ROR1751: Genetic Biomarker Discovery for Metastatic Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Detect cell-free tumor DNA in patients with metastatic prostate cancer
研究概览
简要总结
Biomarkers from circulating cell-free tumor DNA in peripheral blood will identify patients with metastatic prostate cancer diagnosed with C11 choline PET/CT who will benefit from metastasis-directed radiation, ablative therapies, and/or surgery. Tissue and blood will be collected before treatment. If patients receive androgen deprivation, then blood will be collected after neoadjuvant androgen deprivation but before radiation, ablative therapies, or surgery. Subsequent samples will be obtained at 3 months and 6 months following treatment, after which no further patient contact will occur.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Men age 18 years old and older.
- •Histologically proven diagnosis of prostate cancer.
- •Radiographic evidence of non-regional lymph node involvement, pelvic lymph node recurrence, and/or bone metastases.
- •Requiring a clinically directed biopsy or resection of tumor at Mayo Clinic Rochester.
- •Receiving local therapy for metastatic disease with radiation, ablative therapies, and/or surgery at Mayo Clinic Rochester.
- •Willingness to provide blood sample prior to receipt of treatment, as well as after neoadjuvant androgen deprivation therapy and at 3 months and 6 months after radiation, ablation, or surgery.
- •Absence of a second active malignancy.
- •An understanding of the protocol and its requirements, risks, and discomforts.
- •The ability and willingness to sign an informed consent.
排除标准
- •Inability on the part of the patient to understand the informed consent or be compliant with the protocol.
- •History of a serious or life-threatening allergic reaction to local anesthetics (i.e., lidocaine, xylocaine).
结局指标
主要结局
Detect cell-free tumor DNA in patients with metastatic prostate cancer
时间窗: prior to treatment
tissue biopsy
Calculate cell-free tumor DNA in relation to metastasis-directed radiation and androgen deprivation therapy (ADT)
时间窗: before and immediately after ADT and at 3 months and 6 months after radiation
blood draw
次要结局
未报告次要终点