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Study to Determine the Feasibility, Evaluability and Variability in Markers of Drug Action in Castration Resistant Prostate Cancer

NCT02424448 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6

Last updated 2016-07-26

No results posted yet for this study

Summary

This is a biopsy feasibility study in which patients with castration resistant prostate cancer (CRPC) will be asked to donate primary and metastatic tumour tissue (both archival and de novo), blood samples, a urine specimen and clinical data for research.

Conditions

  • Metastatic Castration Resistant Prostate Cancer

Interventions

PROCEDURE

Biopsies, blood and urine samples

Session 1: Biopsies will be taken from the main study lesion and up to 2 metastatic sites at 1 visit or over 3 visits. Both formalin fixed and snap frozen material will be collected. At the session (i.e. once over the potential maximum of 3 visits in a session) a urine sample, blood samples for circulating tumour cells (CTC) and an exploratory blood sample (processed to plasma) will be taken. Session 2: 7 days +/-3 following the last biopsy taken from Session 1, repeat biopsies from the same tumour sites will be obtained. In cases where this is not possible, it is acceptable to biopsy alternative lesions. As in Session 1 biopsies may be taken at 1 visit or over 3 visits and urine, CTC blood samples and an exploratory blood sample (processed to plasma) will be taken.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • The Christie NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Tony Elliott · The Christie NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02424448 on ClinicalTrials.gov