Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer

  • STATUS
    Recruiting
  • End date
    Aug 1, 2027
  • participants needed
    60
  • sponsor
    University of Washington
Updated on 19 February 2024
cancer
metastasis
bone metastases
carcinoma
testosterone
prostate specific antigen
dna damage
metastatic castration-resistant prostate cancer
metastatic prostate cancer
prostate carcinoma
castration-resistant prostate cancer
biospecimen collection
prostate-specific antigen
prostate cancer
metastatic hormone refractory prostate cancer
stage iv prostate cancer
stage ivb prostate cancer ajcc v8
stage iv prostate cancer ajcc v8
stage iva prostate cancer ajcc v8
metastatic malignant neoplasm

Summary

This phase II 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.

Description

OUTLINE

Patients receive standard of care radium Ra 223 dichloride given by intravenous (IV) bolus every 4 weeks for up to 6 cycles. Patients undergo collection of blood every 1-3 months during radium Ra 223 dichloride treatment.

After completion of study, patients are followed up every 3 months for up to 5 years from the date of treatment completion.

Details
Condition Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Metastatic Malignant Neoplasm in the Bone
Age 18years - 100years
Treatment Questionnaire Administration, Biospecimen Collection, Radium Ra 223 Dichloride
Clinical Study IdentifierNCT04489719
SponsorUniversity of Washington
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient must have histopathologic diagnosis of prostate cancer
Patient must meet Food and Drug Administration (FDA) approved criteria (e.g., mCRPC, radiographic evidence of bone metastasis, symptomatic from prostate cancer) for receipt of radium-223 with plans to undergo treatment with such
Patient must have a prostate specific antigen (PSA) level > 20 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
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