Quantification of Circulating tumor DNA derived Structural variants to assess treatment response in metastatic prostate cancer patients

Completed

• Conditions: 10038364; prostate cancer; prostate carcinoma

• Registration Number: NL-OMON43524
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 285

Inclusion Criteria

- metastasized castration resistant prostate cancer
- participation in CPCT-02 study
- age * 18 years
- written informed consent

Exclusion Criteria

- not meeting the inclusion criteria

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the rate of mPC patients with quantifiable<br /><br>tumor-specific SVs in ctDNA from plasma taken pre-treatment; quantifiable is:<br /><br>the number of SV copies per milliliter plasma (load) is above the lower limit<br /><br>of detection (LLD). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary, exploratory endpoints include the overlap in SVs between tumor<br /><br>biopsy samples pre- and post-treatment, the longitudinal assessment of SV load<br /><br>under influence of systemic treatment and the interval between detected<br /><br>variations in SV load PSA response and imaging modality markers.</p><br>