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Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT04489719.
Locations matching your search criteria
United States
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
I. Determine the response rate of bone metastatic castration resistant prostate cancer (mCRPC) with deoxyribonucleic acid (DNA) repair deficiency (DRD) to treatment with radium-223. 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 decline of >= 30% from baseline.
SECONDARY OBJECTIVES:
I. Determine whether patients with DRD will have a statistically significant higher response rate to treatment with radium-223 compared to patients who have intact DNA repair pathways.
II. Determine whether patients who received a prior PARP inhibitor will not have a decrement in response to radium-223 in groups with DRD or intact DNA repair pathways, due to distinct mechanisms of therapeutic action of these two agents on DNA.
III. Determine whether patients receiving radium-223 will have better overall survival in patient groups with DRD compared to patients who have intact DNA repair pathways.
IV. Determine whether patients with DRD will receive more doses of radium-223 compared to patients who have intact DNA repair pathways.
V. Determine whether patients with DRD who receive radium-223 will have less pain compared to patients who have intact DNA repair pathways.
VI. Determine whether patients with DRD who receive radium-223 will have less analgesia requirements compared to patients who have intact DNA repair pathways.
VII. Determine whether patients with DRD who receive radium-223 will have improved quality of life compared to patients who have intact DNA repair pathways.
VIII. Determine whether patients with DRD will experience more adverse events from radium-223 compared to patients who have intact DNA repair pathways.
IX. Determine whether measured of response rates by DRD versus non-DRD patients are modified by germline or somatic alteration status of DNA repair pathways.
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.
Trial PhasePhase II
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
