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

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: [18F] Fluciclovine PET/MRI; Drug: [18F] fluciclovine

• Registration Number: NCT03264456
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-24
• Study First Posted: 2017-08-29
• Study Start: 2017-11-08
• Primary Completion: 2019-01-30
• Results First Submitted: 2019-12-12
• Results First Submitted QC: 2020-01-10
• Results First Posted: 2020-01-22
• Status Verified: 2020-02
• Study Completion: 2020-02-13
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

• High-risk biopsy-proven treatment-naïve prostate adenocarcinoma (Gleason score ≥ 8 and/or serum PSA > 20)

Read More

Exclusion Criteria

• Inability to tolerate or undergo PET/MRI
• Previous or current hematologic or lymphatic disorder (including leukemia, lymphoma, Castleman's disease, etc.)
• Recurrent prostate adenocarcinoma
• Known visceral, osseous, or extrapelvic metastases prior to fluciclovine-PET/MRI
• Known allergy to glucagon or gadolinium-based contrast

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F] Fluciclovine PET/MRI	[18F] Fluciclovine PET/MRI	\[18F\] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer
[18F] Fluciclovine PET/MRI	[18F] fluciclovine	\[18F\] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer

Primary Outcome Measures

Name	Time	Method
Number of Patients With Primary Lesions Detected	Baseline through 24 hr	Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI
Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI	Baseline through 24 hours	Number of patients with nodal metastases detected on \[18F\]fluciclovine PET/MRI

Secondary Outcome Measures

Name	Time	Method
Follow-up	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)
Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham Medical Center; 🇺🇸 Birmingham, Alabama, United States