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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 48 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 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.

Conditions

• Castration-Resistant Prostate Carcinoma
• Metastatic Malignant Neoplasm in the Bone
• Metastatic Prostate Carcinoma
• Stage IVB Prostate Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Radium Ra 223 Dichloride	Given IV

Timeline

• Start date: 2021-04-16
• Primary completion: 2026-08-01
• Completion: 2029-08-01
• First posted: 2020-07-28
• Last updated: 2026-02-17

Locations

4 sites across 1 country: United States