Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Questionnaire Administration, Radium Ra 223 Dichloride.
- Who it may be relevant to
- Registry conditions: Castration-Resistant Prostate Carcinoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of DNA Repair Pathway Alterations Identified by Circulating Tumor DNA on Sensitivity to Radium-223 in Bone Metastatic Castration-Resistant Prostate Cancer
Overview
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.
Interventions
- Procedure Biospecimen Collection
Undergo collection of blood samples - Other Questionnaire Administration
Ancillary studies - Drug Radium Ra 223 Dichloride
Given IV
Primary outcome measures
- Response rate [Time frame: Up to 1 year]
Secondary outcome measures (9)
- Response rate [Time frame: Up to 1 year]
- Response rate in those with previous PARP inhibitor therapy [Time frame: Up to 1 year]
- Overall survival [Time frame: Up to 5 years]
- Number of radium Ra 223 dichloride [Time frame: Up to 6 months]
- Pain assessment [Time frame: Up to 1 year]
- Analgesic usage [Time frame: Up to 1 year]
- Quality of life (FACT-P survey) [Time frame: Up to 1 year]
- Incidence of adverse events [Time frame: Up to 1 year]
- Response rate [Time frame: Up to 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 4 centers
- Johns Hopkins University — Baltimore
- Bozeman Health Deaconess Hospital — Bozeman
- Fred Hutch/University of Washington Cancer Consortium — Seattle
- University of Wisconsin-Madison — Madison
Identifiers
NCT: NCT04489719 · RG1006011 · NCI-2020-04699 · 10370