The Impact of DNA Repair Pathway Alterations Identified by Circulating Tumor DNA on Sensitivity to Radium-223 in Bone Metastatic Castration-Resistant Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Response rate
研究概览
简要总结
This study investigates how well radium-223 works in treating patients with castration-resistant prostate cancer than has spread to the bones (bone metastases). Prostate cancer is the most common cancer in men and the second leading cause of cancer death. Furthermore, many men with notably advanced disease have been found to have abnormalities in DNA repair. The purpose of this research is to study the role of a DNA repair pathway in prostate cancer, specifically in response to administration of radium-223, an FDA-approved drug known to cause DNA damage to cancerous cells. Understanding how defects in the DNA repair pathway affects radium-223 treatment of prostate, may help doctors help plan effective treatment in future patients.
详细描述
OUTLINE:
Patients receive standard of care radium Ra 223 dichloride given by intravenous (IV) bolus every 4 weeks for up to 6 cycles. Patients undergo collection of blood every 1-3 months during radium Ra 223 dichloride treatment.
After completion of study, patients are followed up every 3 months for up to 5 years from the date of treatment completion.
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
- •Patient must be >= 18 years of age
- •Patient must have histopathologic diagnosis of prostate cancer
- •Patient must have castration-resistant prostate cancer
- •Patient must have radiographic evidence of bone metastasis
- •Patients must be symptomatic from prostate cancer
- •Patient must have plans to undergo treatment with radium-223
- •Patient must have a PSA level >= 10 ng/mL
- •Patient must have castrate testosterone levels demonstrated within the last 3 months prior to screening
- •Patient must have anticipated survival > 3 months
- •Patient must be willing and able to authorize consent
- •Patient must be willing and able to comply with the protocol, including follow-up visits
排除标准
- •Patient must not have visceral metastasis
- •Patients on regimens of radium-223 in combination with other antineoplastic agents are excluded
- •* Bone-targeted only therapy (e.g. denosumab or zoledronic acid) will be allowed
- •Patients who have received prior radium-223
- •Patients who have received prior platinum containing chemotherapy
- •Absolute neutrophil count (ANC) < 1.5 x 10^9/L
- •Hemoglobin (HB) < 9 g/dL
- •Platelets (PLT) < 100 x 10^9/L
- •Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
研究组 & 干预措施
Observational (biospecimen collection)
Patients receive standard of care radium Ra 223 dichloride given by IV bolus every 4 weeks for up to 6 cycles. Patients undergo collection of blood every 1-3 months during radium Ra 223 dichloride treatment.
干预措施: Biospecimen Collection (Procedure)
Observational (biospecimen collection)
Patients receive standard of care radium Ra 223 dichloride given by IV bolus every 4 weeks for up to 6 cycles. Patients undergo collection of blood every 1-3 months during radium Ra 223 dichloride treatment.
干预措施: Questionnaire Administration (Other)
Observational (biospecimen collection)
Patients receive standard of care radium Ra 223 dichloride given by IV bolus every 4 weeks for up to 6 cycles. Patients undergo collection of blood every 1-3 months during radium Ra 223 dichloride treatment.
干预措施: Radium Ra 223 Dichloride (Drug)
结局指标
主要结局
Response rate
时间窗: Up to 1 year
Response will be defined as having one or both of the following: confirmed prostate specific antigen (PSA) decline of \>= 30% from baseline AND/OR confirmed alkaline phosphatase (ALP) decline \>= 30% from baseline. Response is evaluated throughout the course of treatment until the post-radium-223 end of treatment laboratory studies. Confirmation of response by PSA and/or ALP requires a second consecutive value obtained \>= 2 weeks after the first with sustained \>= 30% decline. Characterization of response rate to radium-223 in the DRD patient population will be assessed by binomial proportion with Clopper-Pearson exact 2-sided 95% confidence intervals.
次要结局
- Response rate in those with previous PARP inhibitor therapy(Up to 1 year)
- Response rate(Up to 1 year)
- Number of radium Ra 223 dichloride(Up to 6 months)
- Analgesic usage(Up to 1 year)
- Quality of life (FACT-P survey)(Up to 1 year)
- Overall survival(Up to 5 years)
- Pain assessment(Up to 1 year)
- Incidence of adverse events(Up to 1 year)