The Impact of DNA Repair Pathway Alterations Identified by Circulating Tumor DNA on Sensitivity to Radium-223 in Bone Metastatic Castration-Resistant Prostate Cancer


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

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04489719

Sponsor: University of Washington

Phase:

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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

View trial on ClinicalTrials.gov