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Completed

NCT Number: NCT03264456

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, 35249, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[18F] Fluciclovine PET/MRI

Diagnostic Test

[18F] fluciclovine PET/MRI

[18F] fluciclovine

Drug

[18F] fluciclovine

Primary outcomes

  1. 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

  2. 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

  1. 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.

  2. 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)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Aug 29, 2017
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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