NCT04489719Recruiting
Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer
The Impact of DNA Repair Pathway Alterations Identified by Circulating Tumor DNA on Sensitivity to Radium-223 in Bone Metastatic Castration-Resistant Prostate Cancer
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 48 (estimated)
- First submitted
- 23 Jul 2020
- Start date
- 16 Apr 2021
- Primary completion date
- 1 Aug 2027
- Lead sponsor
- University of Washington
- Diseases
- Prostate cancer
- NCT number
- NCT04489719
What you commit to
- Study type: Observational
- Planned participants: 48
- From 16 Apr 2021 to the primary completion date, 1 Aug 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Lab values
- Absolute neutrophil count (ANC) \< 1.5 x 10\^9/L
- Hemoglobin (HB) \< 9 g/dL
- Platelets (PLT) \< 100 x 10\^9/L
Other
- Patient must not have visceral metastasis
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Bozeman Health Deaconess Hospital Coordinator of this site? Confirm its status | Bozeman | United States | Completed |
| University of Wisconsin - Madison Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| Fred Hutch/University of Washington Cancer Consortium Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.