A Prospective, Open-label, Single-arm Study on the Efficacy and Safety of Organoid-Based Drug Sensitivity Screening to Guide the Treatment of mCRPC Patients With Bone Metastasis Progressed After First-line Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Prostate Specific Antigen (PSA) Response Rate
研究概览
简要总结
This observational study aims to learn about the effects and safety of organoid-based drug sensitivity screening in mCRPC patients with bone metastases that progressed after first-line treatment. The main question it seeks to answer is:
Do doctors choose treatment agents based on organoid-based drug sensitivity screening results for mCRPC patients, resulting in a better response?
Participants already took bone metastasis biopsies for genetic testing based on current clinical guidelines. This study only takes residual tissue from biopsies for organoid culture.
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide informed consent.
- •Adult males from 18 to 75 years age.
- •History of histologically or cytologically confirmed adenocarcinoma
- •Documented evidence of metastatic castration resistant prostate cancer (mCRPC) and progressed after first-line treatment at mCRPC.
- •Evidence of target lesion in imaging studies.
- •ECOG performance status 0-1
- •Estimated survival≥12 weeks
排除标准
- •Do not meet the inclusion criteria.
- •Under any other anti-tumor therapy like chemotherapy and/or immunotherapy.
- •Receiving organ transplantation in the last 3 months.
- •Participants with autoimmune diseases or history of HBV, HCV or HIV infection (acute).
- •Participants with pneumonia.
- •Severe concurrent illness or co-morbid disease that would make the subject unsuitable for enrolment
- •Unwilling and unable to provide informed consent.
- •Patients who are judged unsuitable for clinical trial participation by the investigators.
结局指标
主要结局
Prostate Specific Antigen (PSA) Response Rate
时间窗: From enrollment to primary completion of study (up to approximately 3 years)
Proportion of patients with a 50% decrease in PSA from baseline
次要结局
- Duration of Response (DOR)(From enrollment to primary completion of study (up to approximately 3 years))
- Objective Response Rate (ORR)(From enrollment to primary completion of study (up to approximately 3 years))
- Overall Survival (OS)(From enrollment to primary completion of study (up to approximately 3 years))
- Radiologic Progression-free Survival (rPFS)(3 years)
研究者
Yonghong Li
Professor
Sun Yat-sen University