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

NCT ID: NCT03264456

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-08
• Study Completion Date: 2020-02-13

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[18F] Fluciclovine PET/MRI

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

Group Type: EXPERIMENTAL

[18F] Fluciclovine PET/MRI

Intervention Type: DIAGNOSTIC_TEST

\[18F\] fluciclovine PET/MRI

[18F] fluciclovine

Intervention Type: DRUG

\[18F\] fluciclovine

Interventions

[18F] Fluciclovine PET/MRI

\[18F\] fluciclovine PET/MRI

Intervention Type: DIAGNOSTIC_TEST

[18F] fluciclovine

\[18F\] fluciclovine

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Samuel Joseph Galgano

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel Galgano, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33052718 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB-300000291

Identifier Type: -

Identifier Source: org_study_id