CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 104 enrolled
Drug / intervention
18F-Fluciclovine PET CTdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02578940
NCT02578940Phase 3Completed
CompareCT.gov

A Phase 3, Open-label Study to Assess the Clinical Utility of Fluciclovine (18F) PET/CT in Patients With Prostate Cancer With Biochemical Recurrence After Radical Treatment

Blue Earth Diagnostics·interventional·Posted Oct 19, 2015·Updated Oct 7, 2019

In Brief

A Phase 3 clinical trial evaluating 18F-Fluciclovine PET CT for Cancer of the Prostate. Completed, enrolled 104 participants across 7 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer of the Prostate
CountriesUnited Kingdom
CollaboratorsInnovate UK, Syne Qua Non Limited, IND 2 Results LLC

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 19, 2015
Enrollment StartNov 1, 2015
Primary CompletionMay 17, 2017
Study CompletionJun 22, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.7 years ago

Interventions

18F-Fluciclovine PET CTdrug

Radioligand for PET CT scanning