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

NCT ID: NCT04489719

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-16
• Study Completion Date: 2029-08-01

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo collection of blood samples

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Radium Ra 223 Dichloride

Intervention Type: DRUG

Given IV

Interventions

Biospecimen Collection

Undergo collection of blood samples

Intervention Type: PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Radium Ra 223 Dichloride

Given IV

Intervention Type: DRUG

Other Intervention Names

Biological Sample Collection; Biospecimen Collected; Specimen Collection; Alpharadin; BAY 88-8223; BAY88-8223; Radium 223 Dichloride; RADIUM RA-223 DICHLORIDE; Radium-223 Dichloride; Xofigo

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evan Y. Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Site Status: RECRUITING

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Site Status: ACTIVE_NOT_RECRUITING

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status: RECRUITING

University of Wisconsin-Madison

Madison, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Patrick Panlasigui

Role: CONTACT

ppanlas2@fredhutch.org

206-606-7486

Facility Contacts

Noura Radwan

Role: primary

Nradwan1@jh.edu

410-614-1570

Patrick Panlasigui

Role: primary

ppanlas2@fredhutch.org

206-606-7486

Other Identifiers

NCI-2020-04699

Identifier Type: REGISTRY

Identifier Source: secondary_id

10370

Identifier Type: OTHER

Identifier Source: secondary_id

RG1006011

Identifier Type: -

Identifier Source: org_study_id