Investigating DNA Repair and Radium-223 in Advanced 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
This study is testing if radium-223 can help people with advanced prostate cancer that has spread to the bones, while also looking at how changes in DNA repair might affect the treatment's success.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Washington Academic / other |
| Drugs / interventions | denosumab, chemotherapy |
| Locations | 4 sites (Baltimore, Maryland and 3 other locations) |
| Trial ID | NCT04489719 on ClinicalTrials.gov |
What this trial studies
This study examines the effectiveness of radium-223 in treating patients with castration-resistant prostate cancer that has metastasized to the bones. It focuses on understanding how alterations in DNA repair pathways may influence the response to this treatment. Patients will receive radium-223 every four weeks for up to six cycles, with blood samples collected periodically to monitor their condition. Following treatment, participants will be followed for up to five years to assess long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with symptomatic, castration-resistant prostate cancer and radiographic evidence of bone metastasis.
Not a fit: Patients with visceral metastasis or those receiving radium-223 in combination with other antineoplastic agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with advanced prostate cancer.
How similar studies have performed: While the approach of examining DNA repair pathways in relation to radium-223 is innovative, similar studies have shown promise in understanding treatment responses in cancer therapies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland and 3 other locations
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Bozeman Health Deaconess Hospital — Bozeman, Montana, United States (Active_not_recruiting)
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)
- University of Wisconsin-Madison — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Evan Y. Yu, MD — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Jane Romani
- Email: jromani@fredhutch.org
- Phone: 206-606-1909
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.