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

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Ancillary/Correlative

• Registration Number: NCT03677076
• Lead Sponsor: Medical University of South Carolina

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-19
• Study Start: 2019-03-04
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary/Correlative	Ancillary/Correlative	Patients will complete questionnaires and have research blood drawn.

Primary Outcome Measures

Name	Time	Method
Minor allele frequency (MAF) in ctDNA	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 Outcome Measures

Name	Time	Method
Change in clonal mutation MAF and markers of bone metabolism	24 months	• Evaluate the association between change in clonal mutation MAF and markers of bone metabolism including urine N-telopeptide and serum bone-specific alkaline phosphatase, measured by ELISA assays both during therapy and post-treatment.
Changes in MAF of clonal SNV	24 months	• Determine if changes from baseline in MAF of clonal SNVs during therapy and post-treatment differ significantly from 0.
Change in clonal mutation MAF and change in pain	24 months	• Evaluate the association between change from baseline in clonal mutation MAF and change in pain (evaluated by VAS pain score and analgesic usage diary), measured both during therapy and post-treatment.
Change in clonal mutation MAF and change in tumor markers	24 months	• Evaluate the association between change in clonal mutation MAF and change in tumor markers, including prostate specific antigen (PSA), CEA and LDH, measured by standard biochemical assays both during therapy and post-treatment.
Change in clonal mutation MAF and presence of the TMPRSS2-ERG fusion gene	24 months	• Evaluate the association between change in clonal mutation MAF and presence of the TMPRSS2-ERG fusion gene, measured in plasma/urine by digital PCR Evaluate the association between change in clonal mutation MAF and clinical benefit, (time from the last dose of radium-223 to the initiation of a new systemic therapy, measured at least 60 days after final dose) and change in QOL (measured by FACT-P instrument).

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States