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出境医 / 临床实验 / Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI

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

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Diagnostic Test: [18F] Fluciclovine PET/MRI Drug: [18F] fluciclovine Phase 1 Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI
Actual Study Start Date : November 8, 2017
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : February 13, 2020
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
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United States, Alabama
University of Alabama at Birmingham Medical Center
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Layout table for investigator information
Principal Investigator: Samuel Galgano, MD University of Alabama at Birmingham
Tracking Information
First Submitted Date  ICMJE August 22, 2017
First Posted Date  ICMJE August 29, 2017
Results First Submitted Date  ICMJE December 12, 2019
Results First Posted Date  ICMJE January 22, 2020
Last Update Posted Date March 9, 2020
Actual Study Start Date  ICMJE November 8, 2017
Actual Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2017)
  • Number of Primary Lesions and Metastases Detected [ Time Frame: 1 yr ]
    Number of primary lesions and regional nodal metastases detected metastases on 18-F fluciclovine PET/MRI
  • Disease Spread [ Time Frame: 1 yr ]
    Detection of organ-confined disease, regional nodal metastases, extracapsular extension, and seminal vesicle invasion on [18F]fluciclovine PET/MRI in expected frequencies based on risk-predictor models and nomograms
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2020)
  • 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.
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2017)
  • PET/MRI vs. MRI [ Time Frame: 1 yr ]
    Compare number of metastases detected on [18F]fluciclovine PET/MRI to number of metastases detected on prostate MRI alone. 18-F fluciclovine PET/MRI will presumably demonstrate more metastases than MRI alone.
  • Follow-up [ Time Frame: 1 yr ]
    Correlate findings on post-treatment [18F]fluciclovine PET/MRI with initial findings on the pre-treatment PET/MRI and correlate findings at follow-up with serum PSA.
  • PET/MRI Concordance [ Time Frame: 1 yr ]
    Determine concordance between [18F]fluciclovine PET/MRI results and multiparametric prostate MRI results for detection of primary lesion and nodal metastases
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI
Official Title  ICMJE Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Diagnostic Test: [18F] Fluciclovine PET/MRI
    [18F] fluciclovine PET/MRI
  • Drug: [18F] fluciclovine
    [18F] fluciclovine
Study Arms  ICMJE Experimental: [18F] Fluciclovine PET/MRI
[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer
Interventions:
  • Diagnostic Test: [18F] Fluciclovine PET/MRI
  • Drug: [18F] fluciclovine
Publications * 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 (18)F-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. 2020 Oct 14. doi: 10.2214/AJR.20.24509. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2020) 		18
Original Estimated Enrollment  ICMJE
 (submitted: August 24, 2017) 		15
Actual Study Completion Date  ICMJE February 13, 2020
Actual Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03264456
Other Study ID Numbers  ICMJE IRB-300000291
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samuel Joseph Galgano, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Samuel Galgano, MD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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