Actively Recruiting
Impact of DNA Repair Pathway Alterations 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
432 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
B
Bayer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 218 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 210 ng/mL
- Patient must have castrate testosterone levels demonstrated within the last 3 months prior to screening
- Patient must have anticipated survival 23 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) C 1.5 x 10^9/L
- Hemoglobin (HB) C 9 g/dL
- Platelets (PLT) C 100 x 10^9/L
- Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
AI-Screening
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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
CONTACT
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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