NCT03762759

Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes

Active, enrolled Phase 2 Last updated 17 May 2024

What this trial tests

Phase 2 trial testing Computed Tomography in Prostate Adenocarcinoma in 140 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 May 2019

Primary endpoint
31 May 2025

31 December 2025

Quick facts

Lead sponsor	Emory University
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	140
Start date	10 May 2019
Primary completion	31 May 2025
Estimated completion	31 December 2025
Sites	3 locations across United States

Drugs / interventions tested

• Computed Tomography
• Fluciclovine F18 — full drug profile →
• Gallium Ga68-labeled PSMA-11
• Positron Emission Tomography

Conditions studied

• Prostate Adenocarcinoma — all drugs for Prostate Adenocarcinoma →

Sponsor

Emory University

Who can join

18 and older, male only, with Prostate Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies how well a positron emission tomography (PET)/computed tomography (CT) scan using fluciclovine F18 compared with a PET/CT scan with 68Ga-PSMA works in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma. Fluciclovine F18 and 68Ga-PSMA are types of tracers, called radiotracers, that are injected and can accumulate in tumor cells to develop images of them during a PET/CT scan. It is not yet known whether giving fluciclovine F18 or 68Ga-PSMA may work better in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. ¹⁸F-fluciclovine PET-CT and ⁶⁸Ga-PSMA-11 PET-CT in patients with early biochemical recurrence after prostatectomy: a prospective, single-centre, single-arm, comparative imaging trial.
   Calais J, Ceci F, Eiber M, Hope TA, et al · · 2019 · cited 333× · PMID 31375469 · DOI 10.1016/s1470-2045(19)30415-2
2. ¹⁸F-fluciclovine-PET/CT imaging versus conventional imaging alone to guide postprostatectomy salvage radiotherapy for prostate cancer (EMPIRE-1): a single centre, open-label, phase 2/3 randomised controlled trial.
   Jani AB, Schreibmann E, Goyal S, Halkar R, et al · · 2021 · cited 135× · PMID 33971152 · DOI 10.1016/s0140-6736(21)00581-x
3. Appropriate Use Criteria for Prostate-Specific Membrane Antigen PET Imaging.
   Jadvar H, Calais J, Fanti S, Feng F, et al · · 2022 · cited 95× · PMID 34593595 · DOI 10.2967/jnumed.121.263262
4. PSMA Theranostics: Review of the Current Status of PSMA-Targeted Imaging and Radioligand Therapy.
   Jones W, Griffiths K, Barata PC, Paller CJ. · · 2020 · cited 78× · PMID 32466595 · DOI 10.3390/cancers12061367
5. Multimodality Imaging of Prostate Cancer.
   Ghafoor S, Burger IA, Vargas AH. · · 2019 · cited 43× · PMID 31481573 · DOI 10.2967/jnumed.119.228320
6. Impact of Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography on Prostate Cancer Salvage Radiotherapy Management: Results from a Prospective Multicenter Randomized Phase 3 Trial (PSMA-SRT NCT03582774).
   Armstrong WR, Kishan AU, Booker KM, Grogan TR, et al · · 2024 · cited 27× · PMID 38290964 · DOI 10.1016/j.eururo.2024.01.012
7. Meeting report from the Prostate Cancer Foundation PSMA theranostics state of the science meeting.
   Miyahira AK, Pienta KJ, Babich JW, Bander NH, et al · · 2020 · cited 22× · PMID 32865839 · DOI 10.1002/pros.24056
8. Phase 3 multicenter randomized trial of PSMA PET/CT prior to definitive radiation therapy for unfavorable intermediate-risk or high-risk prostate cancer [PSMA dRT]: study protocol.
   Calais J, Zhu S, Hirmas N, Eiber M, et al · · 2021 · cited 18× · PMID 33962579 · DOI 10.1186/s12885-021-08026-w