NCT03677076

Clonal Emergence and Regression During Radium-223 Therapy for Metastatic Prostate Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 14 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	Ancillary/Correlative	Collection of research blood and urine

Timeline

• Start date: 2019-03-04
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2018-09-19
• Last updated: 2024-01-17

Locations

1 site across 1 country: United States