Clonal Emergence and Regression During Radium-223 Therapy for Metastatic Prostate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Medical University of South Carolina
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Minor allele frequency (MAF) in ctDNA
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is for patients with metastatic prostate cancer receiving radium-223 as their standard of care therapy. The researchers will collect blood and urine samples from patients before, during and after the radium-223 therapy. The researchers will compare these samples to observe how the treatment has affected different cancer markers.
Detailed Description
This study proposes to document the presence of clonal emergence and regression during radium-223 therapy for metastatic prostate cancer by serial ctDNA analysis of tumor-associated mutations, using the clinically-available Guardant 360 platform. These data may provide important mechanistic insights into radium-223 therapy by 1) identifying mutations associated with radium-223 resistance or sensitivity, 2) providing new markers of treatment response in an individual, and 3) revealing antitumor effects from radium-223 that are not easily recognized with standard tumor response metrics. Positive finding based on this clinically-available platform will be readily applied by the oncology treatment community.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Minor allele frequency (MAF) in ctDNA
Time Frame: 24 months
The primary objective is to estimate average change in MAF in one or more clonal SNVs, comparing baseline to on-treatment, and baseline to post-treatment samples
Secondary Outcomes
- Change in clonal mutation MAF and markers of bone metabolism(24 months)
- Changes in MAF of clonal SNV(24 months)
- Change in clonal mutation MAF and change in pain(24 months)
- Change in clonal mutation MAF and change in tumor markers(24 months)
- Change in clonal mutation MAF and presence of the TMPRSS2-ERG fusion gene(24 months)