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Observational Study of Radium-223 for Metastatic Castration-Resistant Prostate Cancer

This study is looking at how well Radium Ra 223 Dichloride works in men with prostate cancer that has spread to their bones (bone metastases) and is no longer responding to standard hormone therapy (castration-resistant). Researchers want to understand if changes in DNA repair pathways affect how patients respond to Radium Ra 223 Dichloride, an FDA-approved drug that damages cancer cells' DNA. You would receive Radium Ra 223 Dichloride intravenously (through a vein) and provide blood samples. The study aims to see how many patients respond to the treatment over one year. The study is currently enrolling up to 48 men aged 18 or older who have symptomatic bone metastases from prostate cancer and are planning to receive Radium Ra 223 Dichloride.

Study design
This is an observational study with a planned enrollment of 48 participants. It is not specified if it is a blinded or randomized study.
What's involved
You would receive Radium Ra 223 Dichloride intravenously every 4 weeks for up to 6 cycles. You would also have blood samples collected every 1-3 months during treatment.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you would be followed up every 3 months for up to 5 years from the date of treatment completion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04489719

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

Recruiting
Not specifiedAges 18+Observational
University of Washington
~48 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Biospecimen CollectionQuestionnaire AdministrationRadium Ra 223 Dichloride

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response rate
Measured over Up to 1 year

Conditions

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

Explore related trials

Prostate Carcinoma

Where it's being run

4 sites across 4 states
Maryland1
Montana1
Washington1
Wisconsin1

Study leadership

  • Evan Y. Yu, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Jane Romani
[email protected]
206-606-1909
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Patient must not have visceral metastasis
Patients on regimens of radium-223 in combination with other antineoplastic agents are excluded
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

What this trial measures

  • Response rateUp to 1 year

    Response will be defined as having one or both of the following: confirmed prostate specific antigen (PSA) decline of \>= 30% from baseline AND/OR confirmed alkaline phosphatase (ALP) decline \>= 30% from baseline. Response is evaluated throughout the course of treatment until the post-radium-223 end of treatment laboratory studies. Confirmation of response by PSA and/or ALP requires a second consecutive value obtained \>= 2 weeks after the first with sustained \>= 30% decline. Characterization of response rate to radium-223 in the DRD patient population will be assessed by binomial proportion with Clopper-Pearson exact 2-sided 95% confidence intervals.