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Clinical Trials/NCT03264456
NCT03264456
Completed
Phase 1

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

University of Alabama at Birmingham1 site in 1 country18 target enrollmentNovember 8, 2017

Overview

Phase
Phase 1
Intervention
[18F] Fluciclovine PET/MRI
Conditions
Prostate Cancer
Sponsor
University of Alabama at Birmingham
Enrollment
18
Locations
1
Primary Endpoint
Number of Patients With Primary Lesions Detected
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 8, 2017
End Date
February 13, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Samuel Joseph Galgano

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

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

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

Arms & Interventions

[18F] Fluciclovine PET/MRI

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

Intervention: [18F] Fluciclovine PET/MRI

[18F] Fluciclovine PET/MRI

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

Intervention: [18F] fluciclovine

Outcomes

Primary Outcomes

Number of Patients With Primary Lesions Detected

Time Frame: 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

Time Frame: Baseline through 24 hours

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

Secondary Outcomes

  • Follow-up(Baseline through 8 weeks)
  • Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI(Baseline through 24 hours)

Study Sites (1)

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