Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04489719|
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : May 5, 2021
|Condition or disease||Intervention/treatment|
|Castration-Resistant Prostate Carcinoma Metastatic Malignant Neoplasm in the Bone Metastatic Prostate Carcinoma Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8||Procedure: Biospecimen Collection Other: Questionnaire Administration Drug: Radium Ra 223 Dichloride|
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.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|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|
|Actual Study Start Date :||April 16, 2021|
|Estimated Primary Completion Date :||August 1, 2023|
|Estimated Study Completion Date :||August 1, 2027|
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 Collection
Undergo collection of blood samples
Other: Questionnaire Administration
Drug: Radium Ra 223 Dichloride
- Response rate [ Time Frame: Up to 1 year ]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 (ALP) decline >= 30% from baseline. Response is evaluated throughout the course of treatment until the post-radium-223 end of treatment laboratory studies. Confirmation of response by PSA and/or ALP requires a second consecutive value obtained >= 2 weeks after the first with sustained >= 30% decline. Characterization of response rate to radium-223 in the DRD patient population will be assessed by binomial proportion with Clopper-Pearson exact 2-sided 95% confidence intervals.
- Response rate [ Time Frame: Up to 1 year ]Comparison of treatment response (outcome/dependent variable) between cases and controls will be assessed using multivariate logistic regression modelling adjusting for secondary variables as appropriate. Risk estimates will include odds ratios with 95% confidence intervals.
- Response rate in those with previous PARP inhibitor therapy [ Time Frame: Up to 1 year ]A multivariate logistic model with PARP inhibitor status as a secondary independent variable and a sensitivity analysis excluding those exposed to PARP inhibitors.
- Overall survival [ Time Frame: Up to 5 years ]Survival by DRD status will be illustrated using univariate Kaplan-Meier curves. Additionally, Cox-PH model adjusting for age, Eastern Cooperative Oncology Group (ECOG) performance status, Gleason grade score, baseline ALP, PSA, hemoglobin (HB), and lactate dehydrogenase (LDH) will be performed. This analysis may be limited by expected small number of events, thus it may be limited to raw reporting of events by DRD status.
- Number of radium Ra 223 dichloride [ Time Frame: Up to 6 months ]
- Pain assessment [ Time Frame: Up to 1 year ]Assessed via Brief Pain Inventory survey
- Analgesic usage [ Time Frame: Up to 1 year ]
- Quality of life (FACT-P survey) [ Time Frame: Up to 1 year ]Assessed via FACT-P quality of life survey
- Incidence of adverse events [ Time Frame: Up to 1 year ]To access risk of adverse events by DRD status, 2 logistic models will be used. The first will classify the dependent variable as an adverse event while the second model will classify the dependent variable as an adverse event < grade 3.
- Response rate [ Time Frame: Up to 1 year ]Investigate whether response rates by DRD versus non-DRD patients are modified by germline or somatic alteration status of DNA repair pathways.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04489719
|Contact: Zoya Bauer||(206) email@example.com|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Zoya Bauer 206-606-7486 firstname.lastname@example.org|
|Principal Investigator: Evan Y. Yu|
|Principal Investigator:||Evan Y. Yu||Fred Hutch/University of Washington Cancer Consortium|