RecruitingNCT04489719

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


Sponsor

University of Washington

Enrollment

48 participants

Start Date

Apr 16, 2021

Study Type

OBSERVATIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether specific DNA repair gene mutations in prostate cancer tumors affect how well patients respond to radium-223, a radioactive treatment for bone metastases. The goal is to help doctors predict which patients will benefit most from this treatment. **You may be eligible if...** - You are 18 or older with confirmed prostate cancer - Your cancer is castration-resistant (it has continued to grow despite hormone-lowering therapy) - You have bone metastases visible on imaging - Your PSA level is 10 ng/mL or higher - You are symptomatic from your prostate cancer and are planning to receive radium-223 treatment **You may NOT be eligible if...** - Your cancer has not spread to bones - You are not planning to receive radium-223 - You have very low anticipated survival (less than 3 months) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

OTHERQuestionnaire Administration

Ancillary studies

DRUGRadium Ra 223 Dichloride

Given IV


Locations(4)

Johns Hopkins University

Baltimore, Maryland, United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

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NCT04489719


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