What this study is
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.
What's being tested
- Biospecimen Collection
Intervention · PROCEDURE
Undergo collection of blood samples
- Questionnaire Administration
Intervention · OTHER
Ancillary studies
- Radium Ra 223 Dichloride
Intervention · DRUG
Given IV
Study details
- Official title
- 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
- Conditions
- Castration-Resistant Prostate Carcinoma · Metastatic Malignant Neoplasm in the Bone · Metastatic Prostate Carcinoma · Stage IVB Prostate Cancer AJCC v8
- Enrolling
- 48 people
- Starts
- 2021-04-16
- Est. completion
- 2030-08-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex MALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
3 openJohns Hopkins University
Baltimore, Maryland, United States
- Noura Radwan · Contact410-614-1570Nradwan1@jh.edu
- Ana Kiess, MD · Principal investigator
RecruitingFred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
- Jane Romani · Contact206-606-1909jromani@fredhutch.org
- Evan Y. Yu, MD · Principal investigator
RecruitingUniversity of Wisconsin-Madison
Madison, Wisconsin, United States
- Glenn Liu, MD · Principal investigator
RecruitingBozeman Health Deaconess Hospital
Bozeman, Montana, United States
Completed
Study team
Sponsor
University of Washington
Study ID RG1006011
Principal investigator
Evan Y. Yu, MD
Fred Hutch/University of Washington Cancer Consortium
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.