Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Washington
Study ID
NCT04489719
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 16, 2021
Status verified
Feb 2026
Primary completion
Aug 1, 2026
Completion
Aug 1, 2029

Study Design

Enrollment
48 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Response rate [ Time Frame: Up to 1 year ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21287
Noura Radwan
[email protected]
410-614-1570
Ana Kiess, MD (PRINCIPAL_INVESTIGATOR)
Bozeman Health Deaconess HospitalBozemanMontana59715-
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Jane Romani
[email protected]
206-606-1909
Evan Y. Yu, MD (PRINCIPAL_INVESTIGATOR)
University of Wisconsin-MadisonMadisonWisconsin53705
Glenn Liu, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By research site
Johns Hopkins University· Baltimore, MDBozeman Health Deaconess Hospital· Bozeman, MTFred Hutch/University of Washington Cancer Consortium· Seattle, WAUniversity of Wisconsin-Madison· Madison, WI

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