Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F] Fluciclovine PET/MRI
[18F] fluciclovine
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
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
Sites / Locations
- University of Alabama at Birmingham Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[18F] Fluciclovine PET/MRI
Arm Description
[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer
Outcomes
Primary Outcome Measures
Number of Patients With Primary Lesions Detected
Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI
Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI
Number of patients with nodal metastases detected on [18F]fluciclovine PET/MRI
Secondary Outcome Measures
Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI
Compare number of patients with nodal metastases detected on [18F]fluciclovine PET/MRI to number of patients with metastases detected on prostate MRI alone.
Follow-up
Changes in primary lesion maximum SUV between pretreatment PET/MRI and followup PET/MRI following 8 weeks of androgen deprivation therapy (ADT)
Full Information
NCT ID
NCT03264456
First Posted
August 22, 2017
Last Updated
February 26, 2020
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT03264456
Brief Title
Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI
Official Title
Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
February 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[18F] Fluciclovine PET/MRI
Arm Type
Experimental
Arm Description
[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer
Intervention Type
Diagnostic Test
Intervention Name(s)
[18F] Fluciclovine PET/MRI
Intervention Description
[18F] fluciclovine PET/MRI
Intervention Type
Drug
Intervention Name(s)
[18F] fluciclovine
Intervention Description
[18F] fluciclovine
Primary Outcome Measure Information:
Title
Number of Patients With Primary Lesions Detected
Description
Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI
Time Frame
Baseline through 24 hr
Title
Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI
Description
Number of patients with nodal metastases detected on [18F]fluciclovine PET/MRI
Time Frame
Baseline through 24 hours
Secondary Outcome Measure Information:
Title
Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI
Description
Compare number of patients with nodal metastases detected on [18F]fluciclovine PET/MRI to number of patients with metastases detected on prostate MRI alone.
Time Frame
Baseline through 24 hours
Title
Follow-up
Description
Changes in primary lesion maximum SUV between pretreatment PET/MRI and followup PET/MRI following 8 weeks of androgen deprivation therapy (ADT)
Time Frame
Baseline through 8 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Galgano, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33052718
Citation
Galgano SJ, McDonald AM, Rais-Bahrami S, Porter KK, Choudhary G, Burgan C, Bhambhvani P, Nix JW, Morgan DE, Li Y, Thomas JV, McConathy J. 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. AJR Am J Roentgenol. 2021 Sep;217(3):720-729. doi: 10.2214/AJR.20.24509. Epub 2020 Oct 14.
Results Reference
derived
Learn more about this trial
Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI
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