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
About This Trial
- This study looks at how a patient's natural DNA repair systems affect how well a targeted radiation drug called radium-223 works to fight cancer cells.
- It is for men with advanced prostate cancer that causes symptoms, has spread to the bones, and is no longer responding to standard hormone-lowering treatments.
- Eligible participants must already be planning to receive radium-223 as part of their normal care.
- Before considering this study, you should know that your cancer cannot have spread to internal organs like your liver or lungs, and you cannot have had radium-223 or certain types of chemotherapy in the past.
More Information
- 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.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study looks at how a patient's natural DNA repair systems affect how well a targeted radiation drug called radium-223 works to fight cancer cells.
Study Details
- Start Date: April 16, 2021
- Lead Sponsor: University of Washington
Full 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
Treatments
- Procedure: Biospecimen Collection
- Other: Questionnaire Administration
- Drug: Radium Ra 223 Dichloride