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

February 26, 2020 updated by: Samuel Joseph Galgano, University of Alabama at Birmingham
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [18F] Fluciclovine PET/MRI
[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer
Diagnostic test: [18F] Fluciclovine PET/MRI
[18F] fluciclovine PET/MRI
Drug: [18F] fluciclovine
[18F] fluciclovine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline through 24 hr
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
Baseline through 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI
Time Frame: 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.
Baseline through 24 hours
Follow-up
Time Frame: 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)
Baseline through 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Samuel Galgano, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2017

Primary Completion (Actual)

January 30, 2019

Study Completion (Actual)

February 13, 2020

Study Registration Dates

First Submitted

August 22, 2017

First Submitted That Met QC Criteria

August 24, 2017

First Posted (Actual)

August 29, 2017

Study Record Updates

Last Update Posted (Actual)

March 9, 2020

Last Update Submitted That Met QC Criteria

February 26, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300000291

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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