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Gallium Ga 68-labeled PSMA-11 PET/CT and Fluciclovine F18 PET/CT in Imaging Participants With Recurrent Prostate Cancer After Surgery (PSMA vs AXUMIN)

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ClinicalTrials.gov Identifier: NCT03515577
Recruitment Status : Completed
First Posted : May 3, 2018
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE April 20, 2018
First Posted Date  ICMJE May 3, 2018
Last Update Posted Date July 24, 2020
Actual Study Start Date  ICMJE April 12, 2019
Actual Primary Completion Date April 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
Gallium 68-labeled PSMA-11 ([68]Ga-PSMA-11) and fluciclovine F18 (Axumin) detection rates [ Time Frame: Up to 15 months: through data analysis completion (anonymized central imaging read), an estimation of 3 months after enrollment completion. ]
Will compare rates for the identification of tumor location(s), assessed by patient and region based analysis. This will be calculated and reported along with the corresponding two-sided 95% confidence intervals. The confidence intervals will be constructed using the Wilson score method. Detection rate in the per-participant analysis is defined as number of participants with PET positive disease, independent of pathology or imaging/clinical follow-up. Detection rate in the per-region analysis is defined as number of regions (prostate bed, pelvic lymph-nodes, extra-pelvic lymph-nodes, bone metastases, other soft tissue) resulted PET positive, independent of pathology or imaging/clinical follow-up.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
  • Detection rates on a per-patient basis of 68^Ga-PSMA-11 PET and Axumin PET [ Time Frame: Up to 1 year after completion of PET/CT with 68^Ga-PSMA-11 ]
    This will be stratified by prostate-specific antigen (PSA) value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 - < 2.0, 2.0 - < 5.0, ≥ 5.0) and will be summarized in tabular format and compared between PSA using chi-square analysis. Detection rate is defined as number of participants with PET positive disease, independent of pathology, imaging or clinical follow-up.
  • Sensitivity and PPV by-participant and region-based analysis of 68^Ga-PSMA-11 PET and Axumin PET for detection of tumor location(s) [ Time Frame: Up to 1 year after completion of PET/CT with 68^Ga-PSMA-11 ]
    The sensitivity and positive predictive values (PPV) will be calculated and reported along with the corresponding two-sided 95% confidence intervals. The confidence intervals will be constructed using the Wilson score method. Only participants having histopathology/biopsy and/or clinical and conventional imaging follow-up will be analyzed
  • Inter-observer (reader) agreement [ Time Frame: Up to 15 months: through data analysis completion (anonymized central imaging read), an estimation of 3 months after enrollment completion. ]
    Agreement will be calculated separately for 68^Ga-PSMA-11 PET/CT versus Axumin PET/CT. For binary data, agreement among central readers will be evaluated using Fleiss' k. For non-binary data with more than ten observations, agreement among central readers will be evaluated by interclass correlation coefficient (ICC). Ninety-five percent confidence intervals (CIs) will be reported for k and ICC values. Interpretation of k and ICC will be based on a classification provided by Landis and Koch: 0.0, poor; 0.0-0.20, slight; 0.21-0.40, fair; 0.41-0.60, moderate; 0.61-0.80, substantial; 0.81-1.00, almost-perfect reproducibility.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gallium Ga 68-labeled PSMA-11 PET/CT and Fluciclovine F18 PET/CT in Imaging Participants With Recurrent Prostate Cancer After Surgery
Official Title  ICMJE Prospective Single Center Trial to Compare 68Ga-PSMA-11 and Axumin PET/CT (18F-Fluciclovine) for Restaging Prostate Cancer Patients With Biochemical Recurrence After Radical Prostatectomy
Brief Summary This phase II trial compares how well gallium 68-labeled PSMA-11 positron emission tomography/computed tomography (PET/CT) works compared to fluciclovine F18 PET/CT in imaging participants with prostate cancer after surgery that has come back. PET is an established imaging technique that uses small amounts of radioactivity and CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the body. Diagnostic procedures, such as PET/CT with gallium 68-labeled PSMA-11, may work better than PET/CT with fluciclovine F18 in helping find out how far the prostate cancer has spread.
Detailed Description

PRIMARY OBJECTIVES:

I. To compare the detection rates of gallium 68-labeled PSMA-11 ([68]Ga-PSMA-11) PET/CT and fluciclovine F18 (Axumin) PET/CT for the identification of tumor location(s), by patient and region based analysis.

SECONDARY OBJECTIVES:

I. Detection rate on a per-patient basis of (68)Ga-PSMA-11 PET/CT and Axumin PET/CT, stratified by prostate-specific antigen (PSA) value (0.2 - < 0.5; 0.5 - < 1.0; 1.0 - < 2.0).

II. Sensitivity and positive predictive value (PPV) on a per-patient basis, of (68)Ga-PSMA-11 PET/CT and Axumin PET/CT for the detection of tumor location(s), confirmed by histopathology/biopsy and/or clinical and conventional imaging follow-up.

III. Agreement among the readers, separate for (68)Ga-PSMA-11 PET/CT versus Axumin PET/CT.

OUTLINE:

Participants receive (68)Ga-PSMA-11 intravenously (IV) and 60-90 minutes later, undergo PET/CT imaging over 3 hours. Participants also undergo best standard of care Axumin PET/CT within 2 weeks before or after (68)Ga-PSMA-11 PET/CT.

After completion of the PET/CT scan, participants are followed up between 1 and 3 days and up to 12 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Recurrent Prostate Carcinoma
Intervention  ICMJE
  • Procedure: Computed Tomography
    Undergo PET/CT
    Other Names:
    • CAT
    • CAT Scan
    • Computerized Axial Tomography
    • computerized tomography
    • CT
    • CT SCAN
    • tomography
  • Drug: Fluciclovine F18
    Given fluciclovine F18
    Other Names:
    • (18F)Fluciclovine
    • (18F)GE-148
    • 18F-Fluciclovine
    • [18F]FACBC
    • Anti-(18f)FABC
    • Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid
    • Anti-[18F] FACBC
    • Axumin
    • Fluciclovine (18F)
    • FLUCICLOVINE F-18
    • GE-148 (18F)
    • GE-148 F-18
  • Drug: Gallium Ga 68-labeled PSMA-11
    Given IV
    Other Names:
    • (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
    • (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC
    • (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
    • (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
    • 68Ga-HBED-CC-PSMA
    • 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
    • 68Ga-PSMA-11
    • [68Ga] Prostate-specific Membrane Antigen 11
    • [68Ga]GaPSMA-11
    • Ga-68 labeled PSMA-11
    • Gallium Ga 68 PSMA-11
    • Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
    • PSMA-HBED-CC GA-68
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Procedure: Positron Emission Tomography
    Undergo PET/CT
    Other Names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET Scan
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • proton magnetic resonance spectroscopic imaging
Study Arms  ICMJE Experimental: Diagnostic ([68]Ga-PSMA-11 PET/CT, Axumin PET/CT)
Participants receive (68)Ga-PSMA-11 IV and 60-90 minutes later, undergo PET/CT imaging over 3 hours. Participants also undergo best standard of care Axumin PET/CT within 2 weeks before or after (68)Ga-PSMA-11 PET/CT.
Interventions:
  • Procedure: Computed Tomography
  • Drug: Fluciclovine F18
  • Drug: Gallium Ga 68-labeled PSMA-11
  • Other: Laboratory Biomarker Analysis
  • Procedure: Positron Emission Tomography
Publications * Not Provided

*   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: May 2, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 25, 2019
Actual Primary Completion Date April 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histopathologically proven prostate cancer (PCa)
  • Radical prostatectomy as definitive treatment for PCa
  • Proven biochemical recurrence as defined by American Urological Association (AUA) recommendation: PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after radical prostatectomy
  • PSA values ranging from 0.2 ng/mL to 2 ng/mL
  • No prior salvage therapies (including salvage radiotherapy and/or salvage lymph node dissection)
  • Axumin PET/CT scan already performed or scheduled as best standard of care procedure for suspected disease relapse within 2 weeks before or after intended 68Ga-PSMA-11 PET/CT
  • Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization [WHO] equivalent)
  • Ability to understand a written informed consent document and the willingness to sign it

Exclusion Criteria:

  • Any change in prostate cancer treatment between Axumin and 68Ga-PSMA PET/CT scan
  • Unable to lie flat, still or tolerate a PET scan
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 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 NCT03515577
Other Study ID Numbers  ICMJE 17-001885
NCI-2018-00546 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
17-001885 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
Has Data Monitoring Committee No
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.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonsson Comprehensive Cancer Center
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Johannes Czernin, M.D. UCLA / Jonsson Comprehensive Cancer Center
PRS Account Jonsson Comprehensive Cancer Center
Verification Date June 2019

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