Actively Recruiting
The Impact of DNA Repair Pathway Alterations Identified by Circulating Tumor DNA on Sensitivity to Radium-223 in Bone Metastatic Castration-Resistant Prostate Cancer
Led by University of Washington · Updated on 2026-02-17
48
Participants Needed
4
Research Sites
156 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
B
Bayer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how radium-223 works in treating men with castration-resistant prostate cancer that has spread to the bones. This type of prostate cancer is common and often deadly, and many patients have changes in their DNA repair pathways. The study aims to understand how these DNA repair changes affect the response to radium-223, a drug that damages cancer cell DNA, to help improve future treatments. Participants receive standard radium Ra 223 dichloride through an intravenous injection every four weeks for up to six cycles. Blood samples are collected every one to three months during treatment to study DNA repair and other factors. After treatment, patients are followed every three months for up to five years to monitor their health and outcomes. During the study, participants undergo regular blood tests, pain assessments, quality of life surveys, and monitoring for side effects. Researchers measure treatment response over one year and overall survival up to five years. The study also tracks how pain and pain medication use change during treatment. Participants are observed carefully throughout the study to understand the effects of radium-223 and DNA repair alterations on prostate cancer with bone metastases.
CONDITIONS
Brief Title
Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive radium Ra 223 dichloride given by intravenous bolus every 4 weeks for up to 6 cycles. Blood samples are collected every 1 to 3 months during treatment.
Up to 6 treatment visits every 4 weeks and blood collection visits every 1 to 3 months during treatment
Duration - Up to 5 years
After completing treatment, participants are followed every 3 months for up to 5 years to monitor health outcomes.
Quarterly visits every 3 months for up to 5 years
Trial Site Locations
Total: 4 locations
1
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
2
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States, 59715
Active, Not Recruiting
3
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
4
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
J
Jane Romani
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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