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Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcer

NCT02578940 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2019-10-07

Study results available
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Summary

The main aim is to assess the impact of using 18F-fluciclovine (as a PET imaging radiotracer) on the clinical and treatment decision required for managing patients with biochemically recurrent prostate cancer (BCR) who are being considered for salvage treatment with the intention of providing disease cure. Also, this study will consolidate the information regarding diagnostic performance of fluciclovine PET/CT in a large number of prospectively followed patients at several centres in the UK and assess the effect of PSA level on the likelihood of detecting cancer lesions by 18F-fluciclovine

Conditions

  • Cancer of the Prostate

Interventions

DRUG

18F-Fluciclovine PET CT

Radioligand for PET CT scanning

Sponsors & Collaborators

  • Innovate UK

    collaborator OTHER_GOV

  • Syne Qua Non Limited

    collaborator INDUSTRY

  • IND 2 Results LLC

    collaborator INDUSTRY

  • Blue Earth Diagnostics

    lead INDUSTRY

Principal Investigators

  • Fergus Gleeson, FRCP FRCR · The Oxford University Hospitals NHS Trust

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-05-17
Completion
2018-06-22

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 NCT02578940 on ClinicalTrials.gov