NCT03264456

Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI

Completed Phase 1, PHASE2 Results posted Last updated 9 March 2020

What this trial tests

Phase 1, PHASE2 trial testing [18F] Fluciclovine PET/MRI in Prostate Cancer in 18 participants. Completed in 13 February 2020.

Timeline

8 November 2017

Primary endpoint
30 January 2019

13 February 2020

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	18
Start date	8 November 2017
Primary completion	30 January 2019
Estimated completion	13 February 2020
Sites	1 location across United States

Drugs / interventions tested

• [18F] Fluciclovine PET/MRI
• [18F] fluciclovine

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

University of Alabama at Birmingham

Who can join

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

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With Primary Lesions Detected Primary · Baseline through 24 hr

Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI

Group	Value	95% CI
[18F] Fluciclovine PET/MRI	14

Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI Primary · Baseline through 24 hours

Number of patients with nodal metastases detected on \[18F\]fluciclovine PET/MRI

Group	Value	95% CI
[18F] Fluciclovine PET/MRI	7

Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI Secondary · Baseline through 24 hours

Compare number of patients with nodal metastases detected on \[18F\]fluciclovine PET/MRI to number of patients with metastases detected on prostate MRI alone.

MR alone

Group	Value	95% CI
[18F] Fluciclovine PET/MRI	3

PET/MRI

Group	Value	95% CI
[18F] Fluciclovine PET/MRI	7

Follow-up Secondary · Baseline through 8 weeks

Changes in primary lesion maximum SUV between pretreatment PET/MRI and followup PET/MRI following 8 weeks of androgen deprivation therapy (ADT)

Pretreatment maximum SUV

Group	Value	95% CI
[18F] Fluciclovine PET/MRI	7.1	± 1.7

Maximum SUV after 8 weeks of ADT

Group	Value	95% CI
[18F] Fluciclovine PET/MRI	3.5	± 2.0

Sponsor's own description

There is great need for improved preoperative imaging in men with high-risk prostate cancer. Investigators propose to develop and validate an optimized simultaneous PET/MRI protocol for local, regional and whole body preoperative staging in a single imaging session using the amino acid PET tracer, F-18 fluciclovine. Despite advances in the diagnosis and treatment of prostate cancer, the preoperative staging of men with prostate carcinoma (PCa) is currently problematic. Conventional imaging is falsely negative for regional lymph node metastases in a substantial fraction of men. In particular, approximately 35% of men with high-risk prostate cancer will have biochemical recurrence even after optimal surgical resection. A major benefit of simultaneous acquisition of a multiparametric prostate MRI (mpMRI) and F-18 fluciclovine PET includes having the patient undergo a single imaging study which provides both anatomic and molecular characterization of the tumor, including metastases which would potentially be missed by conventional anatomic imaging and size criteria. Additionally, simultaneous acquisition will improve co-registration of the PET and MR data which is valuable for small lesions and in anatomically complex regions. Although the use of fluciclovine in the characterization of the primary PCa remains to be established, the anatomic detail provided by conventional mpMRI will complement the detection of small volume metastatic disease by fluciclovine PET. Additionally, the use of hybrid PET/MRI technology allows for the assessment of dynamic tracer uptake and washout during the whole body and regional PET/MRI scan, which may demonstrate the ability to increase detection of the primary PCa on fluciclovine PET. If F-18 fluciclovine PET/MRI can reliably and accurately detect nodal metastases in high-risk prostate cancer patients, surgeons may use this new technology to develop new treatment algorithms for the optimal management of these patients.

Publications & conference data

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

1. Utility of ¹⁸F-Fluciclovine PET/MRI for Staging Newly Diagnosed High-Risk Prostate Cancer and Evaluating Response to Initial Androgen Deprivation Therapy: A Prospective Single-Arm Pilot Study.
   Galgano SJ, McDonald AM, Rais-Bahrami S, Porter KK, et al · · 2021 · cited 12× · PMID 33052718 · DOI 10.2214/ajr.20.24509
2. Feasibility of Dose Escalating [¹⁸F]fluciclovine Positron Emission Tomography Positive Pelvic Lymph Nodes During Moderately Hypofractionated Radiation Therapy for High-Risk Prostate Cancer.
   McDonald AM, Galgano SJ, McConathy JE, Yang ES, et al · · 2019 · cited 2× · PMID 31673658 · DOI 10.1016/j.adro.2019.05.008
3. [¹⁸F]Fluciclovine-PET Guided Salvage Lymph Node Dissection Following Radical Prostatectomy.
   Galgano SJ, Calderone CE, Nix JW, Rais-Bahrami S. · · 2019 · cited 2× · PMID 31152764 · DOI 10.1016/j.urology.2019.05.022
4. Unravelling SLC7 family members in thyroid cancer and translational barriers
   Naeem M, Wu N, Cao L, Wu Y, et al · · 2026