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

NCT03264456 | Completed Phase 1 Results FDA Drug

• 1 other identifier: IRB-300000291
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Primary Lesions Detected

  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

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

  Baseline through 24 hours

Secondary Outcomes (2)

• Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI

  Baseline through 24 hours

• Follow-up

  Baseline through 8 weeks

Study Arms (1)

[18F] Fluciclovine PET/MRI

EXPERIMENTAL

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

Diagnostic Test: [18F] Fluciclovine PET/MRI; Drug: [18F] fluciclovine

Interventions

[18F] Fluciclovine PET/MRI DIAGNOSTIC_TEST

\[18F\] fluciclovine PET/MRI

[18F] Fluciclovine PET/MRI

[18F] fluciclovine DRUG

\[18F\] fluciclovine

[18F] Fluciclovine PET/MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, 35249, United States

Location

Related Publications (1)

• 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.

  PMID: 33052718 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Samuel Galgano
• Organization: University of Alabama at Birmingham

samuelgalgano@uabmc.edu

2059341388

Study Officials

• Samuel Galgano, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 29, 2017
• Study Start: November 8, 2017
• Primary Completion: January 30, 2019
• Study Completion: February 13, 2020
• Last Updated: March 9, 2020
• Results First Posted: January 22, 2020

Record last verified: 2020-02

Locations

US (1)