The Impact of DNA Repair Pathway Alterations Identified by Circulating Tumor DNA on Sensitivity to Radium-223 in Bone Metastatic Castration-Resistant Prostate Cancer
University of Washington
Summary
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.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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 a…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- OtherQuestionnaire Administration
Ancillary studies
- DrugRadium Ra 223 Dichloride
Given IV
Locations (4)
- Johns Hopkins UniversityBaltimore, Maryland
- Bozeman Health Deaconess HospitalBozeman, Montana
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington
- University of Wisconsin-MadisonMadison, Wisconsin