The Impact of DNA Repair Pathway Alterations Identified by Circulating Tumor DNA on Sensitivity to Radium-223 in Bone Metastatic Castration-Resistant Prostate Cancer
Condition: Castration-Resistant Prostate Carcinoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
Study Type: Observational
Clinical Trials Identifier NCT 8-digits: NCT04489719
Sponsor: University of Washington
Phase:
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: Male
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
View trial on ClinicalTrials.gov