Status:
RECRUITING
Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Bayer
Conditions:
Castration-Resistant Prostate Carcinoma
Metastatic Malignant Neoplasm in the Bone
Eligibility:
MALE
18+ years
Brief 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 canc...
Detailed 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 radi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 16 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04489719
Start Date
April 16 2021
End Date
August 1 2029
Last Update
August 21 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins University
Baltimore, Maryland, United States, 21287
2
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States, 59715
3
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
4
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53705