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.
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
Patient must not have visceral metastasis
Patients on regimens of radium-223 in combination with other antineoplastic agents are excluded
Patients who have received prior radium-223
Patients who have received prior platinum containing chemotherapy
Patients with mCRPC with bone metastases who are undergoing treatment with radium-223
Cohort
Prospective
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Questionnaire Administration
Other interventionAncillary studies
Radium Ra 223 Dichloride
DrugGiven IV
Response rate
Response will be defined as having one or both of the following: confirmed prostate specific antigen (PSA) decline of \>= 30% from baseline AND/OR confirmed alkaline phosphatase (ALP) decline \>= 30% from baseline. Response is evaluated throughout the course of treatment until the post-radium-223 end of treatment laboratory studies. Confirmation of response by PSA and/or ALP requires a second consecutive value obtained \>= 2 weeks after the first with sustained \>= 30% decline. Characterization of response rate to radium-223 in the DRD patient population will be assessed by binomial proportion with Clopper-Pearson exact 2-sided 95% confidence intervals.
Response rate
Comparison of treatment response (outcome/dependent variable) between cases and controls will be assessed using multivariate logistic regression modelling adjusting for secondary variables as appropriate. Risk estimates will include odds ratios with 95% confidence intervals.
Response rate in those with previous PARP inhibitor therapy
A multivariate logistic model with PARP inhibitor status as a secondary independent variable and a sensitivity analysis excluding those exposed to PARP inhibitors.
Overall survival
Survival by DRD status will be illustrated using univariate Kaplan-Meier curves. Additionally, Cox-PH model adjusting for age, Eastern Cooperative Oncology Group (ECOG) performance status, Gleason grade score, baseline ALP, PSA, hemoglobin (HB), and lactate dehydrogenase (LDH) will be performed. This analysis may be limited by expected small number of events, thus it may be limited to raw reporting of events by DRD status.
Number of radium Ra 223 dichloride
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University of Washington
Lead sponsor
Bayer
Collaborator
