RecruitingNCT04489719

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

Sponsor

University of Washington

Enrollment

48 participants

Start Date

Apr 16, 2021

Study Type

OBSERVATIONAL

Conditions

Castration-Resistant Prostate Carcinoma Metastatic Prostate Carcinoma Stage IVB Prostate Cancer AJCC v8 Metastatic Malignant Neoplasm in the Bone

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

Sex: MALEMin Age: 18 Years

Inclusion Criteria11

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 Criteria9

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