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Castration-Resistant Prostate CarcinomaNCT04489719

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

An observational study of Castration-Resistant Prostate Carcinoma and Metastatic Malignant Neoplasm in the Bone, run by University of Washington at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Biospecimen Collection, Questionnaire Administration and Radium Ra 223 Dichloride
How many people
48 participants
Where
4 sitesUnited States
Study dates
16 Apr 2021to 1 Aug 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with mCRPC with bone metastases who are undergoing treatment with radium-223

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jane Romani contact

206-606-1909

jromani@fredhutch.org

United States4 sites, 3 recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21287

    Noura Radwan, 410-614-1570, Nradwan1@jh.edu

    Ana Kiess, MD

    Recruiting

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

    Completed

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53705

    Glenn Liu, MD

    Recruiting

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

    Jane Romani, 206-606-1909, jromani@fredhutch.org

    Evan Y. Yu, MD

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

OUTLINE:

Patients receive standard of care radium Ra 223 dichloride given by intravenous (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.

After completion of study, patients are followed up every 3 months for up to 5 years from the date of treatment completion.

Being tested
Biospecimen Collection, Questionnaire Administration, Radium Ra 223 Dichloride
Keywords
Prostate
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood samples

  • Questionnaire AdministrationOther

    Ancillary studies

  • Radium Ra 223 DichlorideDrug

    Also called Alpharadin, BAY 88-8223, BAY88-8223, Radium 223 Dichloride

    Given IV

Study groups in NCT04489719
Study groupRoleWhat they receive
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.
Receives: Procedure: Biospecimen Collection; Other: Questionnaire Administration; Drug: Radium Ra 223 Dichloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    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.

    Measured: Up to 1 year

Secondary outcomes (9)

  1. Response rate

    Comparison of treatment response (outcome/dependent variable) between cases and controls will be assessed using multivariate logistic regression modelling adjusting for secondary variables as appropriate. Risk estimates will include odds ratios with 95% confidence intervals.

    Measured: Up to 1 year

  2. Response rate in those with previous PARP inhibitor therapy

    A multivariate logistic model with PARP inhibitor status as a secondary independent variable and a sensitivity analysis excluding those exposed to PARP inhibitors.

    Measured: Up to 1 year

  3. Overall survival

    Survival by DRD status will be illustrated using univariate Kaplan-Meier curves. Additionally, Cox-PH model adjusting for age, Eastern Cooperative Oncology Group (ECOG) performance status, Gleason grade score, baseline ALP, PSA, hemoglobin (HB), and lactate dehydrogenase (LDH) will be performed. This analysis may be limited by expected small number of events, thus it may be limited to raw reporting of events by DRD status.

    Measured: Up to 5 years

  4. Number of radium Ra 223 dichloride

    Measured: Up to 6 months

  5. Pain assessment

    Assessed via Brief Pain Inventory survey

    Measured: Up to 1 year

  6. Analgesic usage

    Measured: Up to 1 year

  7. Quality of life (FACT-P survey)

    Assessed via FACT-P quality of life survey

    Measured: Up to 1 year

  8. Incidence of adverse events

    To access risk of adverse events by DRD status, 2 logistic models will be used. The first will classify the dependent variable as an adverse event while the second model will classify the dependent variable as an adverse event < grade 3.

    Measured: Up to 1 year

  9. Response rate

    Investigate whether response rates by DRD versus non-DRD patients are modified by germline or somatic alteration status of DNA repair pathways.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2020
  2. Study start16 Apr 2021
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04489719
Sponsor's protocol ID
RG1006011
Other IDs
NCI-2020-04699, 10370
Status last verified
Aug 2026
First submitted
23 Jul 2020
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Castration-Resistant Prostate Carcinoma and Metastatic Malignant Neoplasm in the Bone, run by University of Washington at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jane Romani (206-606-1909, jromani@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04489719.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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