Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer
Conditions
Castration-Resistant Prostate Carcinoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8Drugs
Radium Ra 223 DichlorideSummary
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.
Detailed 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.
Locations
3 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Noura Radwan
- 410-614-1570
- [email protected]
Principal Investigator
- Evan Y. Yu, MD
Status
- RECRUITING
Contact Person
- Patrick Panlasigui
- 206-606-7486
- [email protected]
Principal Investigator
- Evan Y. Yu, MD
Status
- RECRUITING
Contact Person
- Glenn Liu, MD
Principal Investigator
- Evan Y. Yu, MD
Eligibility Criteria
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
Study Plan
Observational (biospecimen collection)
Patients receive standard of care radium Ra 223 dichloride given by 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.
PROCEDURE:
Biospecimen CollectionDescription:
Undergo collection of blood samplesOTHER:
Questionnaire AdministrationDescription:
Ancillary studiesDRUG:
Radium Ra 223 DichlorideDescription:
Given IV
Outcome Measures
Primary Outcome Measures
Response rate
Secondary Outcome Measures
Response rate
Response rate in those with previous PARP inhibitor therapy
Overall survival
Number of radium Ra 223 dichloride
Pain assessment
Analgesic usage
Quality of life (FACT-P survey)
Incidence of adverse events
Response rate
Timeline
Last Updated
August 19, 2024Start Date
July 28, 2020Today
February 5, 2025Completion Date ( Estimated )
August 1, 2028
Sponsors of this trial
Lead Sponsor
University of WashingtonCollaborating Sponsors
Bayer