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
Location: See all (4) locations...
Intervention Type: Drug, Other, Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Montana
Bozeman Health Deaconess Hospital
ACTIVE_NOT_RECRUITING
Bozeman
Washington
Fred Hutch/University of Washington Cancer Consortium
RECRUITING
Seattle
Wisconsin
University of Wisconsin-Madison
RECRUITING
Madison
Contact Information
Primary
Patrick Panlasigui
ppanlas2@fredhutch.org
206-606-7486
Time Frame
Start Date: 2021-04-16
Estimated Completion Date: 2029-08-01
Participants
Target number of participants: 48
Treatments
Observational (biospecimen collection)
Patients receive standard of care radium Ra 223 dichloride given by 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.
Authors
Related Therapeutic Areas
Sponsors
Collaborators: Bayer
Leads: University of Washington

This content was sourced from clinicaltrials.gov

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