NCT03515577: PSMA vs AXUMIN

Gallium Ga 68-labeled PSMA-11 PET/CT and Fluciclovine F18 PET/CT in Imaging Participants With Recurrent Prostate Cancer After Surgery

Completed Phase 2 Last updated 14 October 2020

What this trial tests

Phase 2 trial testing Computed Tomography in Recurrent Prostate Carcinoma in 50 participants. Completed in 25 April 2019.

Timeline

12 April 2019

Primary endpoint
25 April 2019

25 April 2019

Quick facts

Lead sponsor	Jonsson Comprehensive Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	50
Start date	12 April 2019
Primary completion	25 April 2019
Estimated completion	25 April 2019
Sites	1 location across United States

Drugs / interventions tested

• Computed Tomography
• Fluciclovine F18 — full drug profile →
• Gallium Ga 68-labeled PSMA-11 — full drug profile →
• Laboratory Biomarker Analysis — full drug profile →
• Positron Emission Tomography

Conditions studied

• Recurrent Prostate Carcinoma — all drugs for Recurrent Prostate Carcinoma →

Sponsor

Jonsson Comprehensive Cancer Center — full company profile →

Who can join

19 and older, male only, with Recurrent Prostate Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial compares how well gallium 68-labeled PSMA-11 positron emission tomography/computed tomography (PET/CT) works compared to fluciclovine F18 PET/CT in imaging participants with prostate cancer after surgery that has come back. PET is an established imaging technique that uses small amounts of radioactivity and CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the body. Diagnostic procedures, such as PET/CT with gallium 68-labeled PSMA-11, may work better than PET/CT with fluciclovine F18 in helping find out how far the prostate cancer has spread.

Publications & conference data

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

1. Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial.
   Fendler WP, Calais J, Eiber M, Flavell RR, et al · · 2019 · cited 592× · PMID 30920593 · DOI 10.1001/jamaoncol.2019.0096
2. 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
3. PSMA-PET/CT Findings in Patients With High-Risk Biochemically Recurrent Prostate Cancer With No Metastatic Disease by Conventional Imaging.
   Holzgreve A, Armstrong WR, Clark KJ, Benz MR, et al · · 2025 · cited 44× · PMID 39752157 · DOI 10.1001/jamanetworkopen.2024.52971
4. Multimodality Imaging of Prostate Cancer.
   Ghafoor S, Burger IA, Vargas AH. · · 2019 · cited 43× · PMID 31481573 · DOI 10.2967/jnumed.119.228320
5. Total-Body ⁶⁸Ga-PSMA-11 PET/CT for Bone Metastasis Detection in Prostate Cancer Patients: Potential Impact on Bone Scan Guidelines.
   Pomykala KL, Czernin J, Grogan TR, Armstrong WR, et al · · 2020 · cited 35× · PMID 31541035 · DOI 10.2967/jnumed.119.230318
6. 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
7. Evaluation of SUV normalized by lean body mass (SUL) in ⁶⁸Ga-PSMA11 PET/CT: a bi-centric analysis.
   Gafita A, Calais J, Franz C, Rauscher I, et al · · 2019 · cited 16× · PMID 31792771 · DOI 10.1186/s13550-019-0572-z
8. European Association of Nuclear Medicine October 22 - 30, 2020 Virtual.
   · 2020 · cited 6× · PMID 32945931 · DOI 10.1007/s00259-020-04988-4