Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Number, type and frequency of DDR and MMR germline/somatic alterations
研究概览
简要总结
400 patients will be enrolled and divided into 3 cohorts: Cohort A: patients with high risk localized prostate cancer (PC) defined as >cT3 or PSA > 20 ng/mL or presence of ECE or SVI at mpMRI;
Cohort B: patients with de novo metastatic hormone sensitive prostate cancer (mHSPC);
Cohort C: patients with metastatic castration resistant prostate cancer (mCRPC) progressing on a standard treatment.
详细描述
In this study 150 patients will be enrolled in cohort A, 100 patients in cohort B and 100-150 patients in Cohort C.
Considering the known frequency of DDR and MMR germline/somatic alterations, it is expected to see:
- 15-23 patients with germline/somatic DDR defects and 5-7 MMR alterations in cohort A;
- 20-25 patients with germline/somatic DDR defects and 5-7 MMR alterations in cohort B;
- 25-35 patients with germline/somatic DDR defects and 7-10 MMR alterations in cohort C.
Patients within Cohort A will be followed up with PSA every 3 months for 3 years and early scans. They will also receive a blood sample for ctDNA/CTC before (when feasible) and after radical treatment, 6 months and 12 months (if not progressed), at time of PSA or radiological progression;
Patients within Cohort B will be followed up with PSA and scans every 3 months. They will also receive a blood sample before (when feasible) or after the start of systemic treatment, 6 months and 12 months (if not progressed), at time of PSA or radiological progression.
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
- •Age > 18 years
- •Diagnosis of prostate cancer as indicated below:
- •Cohort A: patients with high risk localized prostate cancer (defined as >cT3 or PSA > 20 ng/mL or presence of ECE or SVIat mpMRI), with tissue available from diagnostic biopsy/ prostatectomy undergoing or who underwent curative treatment (prostatectomy/ radical radiotherapy) but have not started a FU pathway.
- •Cohort B: patients with de novo metastatic hormone sensitive prostate cancer (mHSPC) with tissue available from diagnostic biopsy of the primary and when possiblepossible, from a metastatic site. Patients must either have not started a standard treatment or have started for not longer than 3 months.
- •Cohort C: patients with metastatic castration resistant prostate cancer tissue (mCRPC) progressing on a standard treatment with available from biopsy of a metastatic site, and when possiblepossible, from the primary.
- •Ability to understand and consent to informed consent;
- •Patient must be compliant with receiving a biopsy of the metastatic site (cohort C) and with FU assessments schedule
排除标准
- •Patients not willing to comply with study's procedures or fulfilling the inclusion criteria.
结局指标
主要结局
Number, type and frequency of DDR and MMR germline/somatic alterations
时间窗: 24 months
Evaluation of the frequency, number and type of DDR and MMR germline/somatic alterations in the study population
Changes in PSA levels in the 3 cohorts
时间窗: 36 months
Evaluation of PSA levels (baseline versus follow-up) in the 3 cohorts compared with radiological assessment
次要结局
- Number of patient-derived preclinical models(36 months)