CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
18F-fluciclovine PET Scandrug
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/NCT04158245
NCT04158245Phase 2Completed
CompareCT.gov

Changes in 18F-fluciclovine Positron Emission Tomography (PET) in Patients With Metastatic Castration Resistant Prostate Cancer Treated With With Life Prolonging Therapies: A Pilot Study

Tulane University·interventional·Posted Nov 8, 2019·Updated Sep 22, 2025

In Brief

A Phase 2 clinical trial evaluating 18F-fluciclovine PET Scan for Metastatic Castration-resistant Prostate Cancer. Completed, enrolled 9 participants across 1 site.

Detailed Summary

This is a pilot phase 2 single-arm study, of men with metastatic castration-resistant prostate cancer (mCRPC). Patients will be treated with any of the approved life-prolonging therapies: abiraterone 1000 mg daily plus prednisone 5 mg (or dexamethasone 0.5 mg) daily, enzalutamide 160 mg daily, or docetaxel 50 mg/m2 every two weeks or 75 mg/m2 every three weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Castration-resistant Prostate Cancer
CountriesUnited States
CollaboratorsBlue Earth Diagnostics

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedNov 8, 2019
Enrollment StartJan 30, 2020
Primary CompletionSep 30, 2022
Study CompletionApr 3, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 6.6 years ago

Interventions

18F-fluciclovine PET Scandrug

The use of 18F-fluciclovine PET scanning will allow a more sensitive assessment of mCRPC patients at the initiation of systemic therapy and changes observed in 18F-fluciclovine PET will correlate better with the serologic changes in PSA, allowing superior disease monitoring, as compared to conventional imaging modalities. In addition, 18F-fluciclovine PET will detect heterogeneity in disease response and thus identify potential lesions amenable to targeted therapy.