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Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer

NCT04489719 · University of Washington
In plain English

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Official title
The Impact of DNA Repair Pathway Alterations Identified by Circulating Tumor DNA on Sensitivity to Radium-223 in Bone Metastatic Castration-Resistant Prostate Cancer
About this study
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 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
Study design
Enrollment target: 48 participants
Age groups: adult, older_adult
Timeline
Starts: 2021-04-16
Estimated completion: 2029-08-01
Last updated: 2026-02-17
Interventions
Procedure: Biospecimen CollectionOther: Questionnaire AdministrationDrug: Radium Ra 223 Dichloride
Primary outcomes
  • Response rate (Up to 1 year)
Sponsor
University of Washington · other
With: Bayer
Contacts & investigators
ContactJane Romani · contact · jromani@fredhutch.org · 206-606-1909
InvestigatorEvan Y. Yu, MD · principal_investigator, Fred Hutch/University of Washington Cancer Consortium
All locations (4)
Johns Hopkins UniversityRecruiting
Baltimore, Maryland, United States
Bozeman Health Deaconess HospitalActive Not Recruiting
Bozeman, Montana, United States
Fred Hutch/University of Washington Cancer ConsortiumRecruiting
Seattle, Washington, United States
University of Wisconsin-MadisonRecruiting
Madison, Wisconsin, United States
Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer · TrialPath