Recruiting

Radium-223

Sponsor:

University of Washington

Code:

NCT04489719

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+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Questionnaire Administration

Radium Ra 223 Dichloride

Study Details

Brief 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.

Conditions

Castration-Resistant Prostate Carcinoma

Metastatic Malignant Neoplasm in the Bone

Metastatic Prostate Carcinoma

Stage IVB Prostate Cancer AJCC v8

Study ID

NCT04489719

Start date

Apr 16, 2021

Status verified date

Aug, 2026

Completion date

Aug 1, 2030

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

48 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Biospecimen Collection

Undergo collection of blood samples

Questionnaire Administration

Ancillary studies

Radium Ra 223 Dichloride

Given IV

Primary outcome measure

  • Response rate [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Jane Romani

206-606-1909jromani@fredhutch.org

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Noura Radwan

410-614-1570Nradwan1@jh.edu

Principal Investigator:

Ana Kiess, MD

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Jane Romani

206-606-1909jromani@fredhutch.org

Principal Investigator:

Evan Y. Yu, MD

University of Wisconsin-Madison

Recruiting

Madison, Wisconsin, United States, 53705

Principal Investigator:

Glenn Liu, MD

More Information

Sponsor

University of Washington

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • Prostate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-08-12.