NCT04489719 Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer
| NCT ID | NCT04489719 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Castration-Resistant Prostate Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 48 participants |
| Start Date | 2021-04-16 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 48 participants in total. It began in 2021-04-16 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Evan Y. Yu, MD
PRINCIPAL INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Frequently Asked Questions
Who can join the NCT04489719 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Castration-Resistant Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04489719 currently recruiting?
Yes, NCT04489719 is actively recruiting participants. Contact the research team at jromani@fredhutch.org for enrollment information.
Where is the NCT04489719 trial being conducted?
This trial is being conducted at Baltimore, United States, Bozeman, United States, Seattle, United States, Madison, United States.
Who is sponsoring the NCT04489719 clinical trial?
NCT04489719 is sponsored by University of Washington. The principal investigator is Evan Y. Yu, MD at Fred Hutch/University of Washington Cancer Consortium. The trial plans to enroll 48 participants.