Home › Prostate Cancer › NCT04489719
Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer
The Impact of DNA Repair Pathway Alterations Identified by Circulating Tumor DNA on Sensitivity to Radium-223 in Bone Metastatic Castration-Resistant Prostate Cancer
Who can join
Ages 18 and older · Men
Full eligibility criteria
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
About the study
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.
What is being tested
- Biospecimen Collection (procedure)
- Questionnaire Administration (other)
- Radium Ra 223 Dichloride (drug)
Sponsor: University of Washington · Participants: 48 · Started: Apr 16, 2021
Contact the study team
- Jane Romani · Phone: 206-606-1909
Official record on ClinicalTrials.gov — NCT04489719
Locations in the U.S.
| Maryland | Johns Hopkins University, Baltimore |
| Washington | Fred Hutch/University of Washington Cancer Consortium, Seattle |
| Wisconsin | University of Wisconsin-Madison, Madison |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.