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Gallium Ga 68-labeled PSMA-11 PET/CT in Detecting Recurrent Prostate Cancer in Patients After Initial Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02940262
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE October 19, 2016
First Posted Date  ICMJE October 20, 2016
Last Update Posted Date July 2, 2021
Actual Study Start Date  ICMJE September 15, 2016
Actual Primary Completion Date June 18, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2020)
Sensitivity on a per-patient and per-region-basis of gallium Ga 68-labeled PSMA-11 positron emission tomography for detection of tumor location [ Time Frame: Up to 12 months ]
Confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2016)
Diagnostic performance of 68Ga-PSMA-11 PET/CT assessed by detected lesion [ Time Frame: Up to 1 year ]
Diagnostic performance of 68Ga-PSMA-11 PET/CT will be compared to conventional imaging for detecting recurrent prostate cancer. Lesion outcomes will be tabulated, separately for 68Ga-PSMA-11 PET/CT and conventional imaging for all patients and by number of lesions on the scans. The accuracy of the investigational test will be summarized by percent agreement with the reference standard and by the kappa statistic. The operating characteristics of sensitivity and specificity will be calculated with 95% confidence intervals based on the binomial distribution.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2020)
  • Positive predictive value (PPV) on a per-patient and per-region-basis of gallium Ga 68-labeled PSMA-11 positron emission tomography for detection of tumor location [ Time Frame: Up to 12 months ]
    Confirmed by histopathology/biopsy and, clinical and conventional imaging follow-up. Will be calculated and reported along with the corresponding two-sided 95% confidence intervals. The paired McNemar's test will be used to compare the positive predictive values of gallium Ga 68-labeled PSMA-11 positron emission tomography imaging to the positive predictive values of conventional imaging.
  • Sensitivity and PPV on a per-patient and per-region-basis of 68Ga-PSMA-11 positron emission tomography (PET) for detection of tumor location confirmed by histopathology/biopsy [ Time Frame: Up to 12 months ]
    Will be summarized in tabular format. Ninety-five confidence intervals of sensitivity, specificity, and net present value (NPV) will be calculated using the Wilson score method.
  • Detection rates on a per-patient basis of gallium Ga 68-labeled PSMA-11 positron emission tomography stratified by PSA value [ Time Frame: Up to 12 months ]
    Detection rates on a per-patient basis of gallium Ga 68-labeled PSMA-11 positron emission tomography stratified by PSA value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 - < 2.0, 2.0 - < 5.0, >= 5.0) and PSA velocity/doubling-time will be summarized in tabular format and compared between PSA strata using chi-square analysis.
  • Detection rates on a per-patient basis of gallium Ga 68-labeled PSMA-11 positron emission tomography stratified by PSA velocity and PSA doubling-time [ Time Frame: Up to 12 months ]
    Detection rates on a per-patient basis of gallium Ga 68-labeled PSMA-11 positron emission tomography stratified by PSA value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 - < 2.0, 2.0 - < 5.0, >= 5.0) and PSA velocity/doubling-time will be summarized in tabular format and compared between PSA strata using chi-square analysis.
  • Clinical management in biochemical recurrence patients [ Time Frame: Up to 12 months ]
    The impact of gallium Ga 68-labeled PSMA-11 positron emission tomography on clinical management in biochemical recurrence patients will be evaluated using descriptive statistics.
  • Inter-reader reproducibility [ Time Frame: Up to 12 months ]
    Inter-reader reproducibility for positivity at the patient level and region level will be reported using the Fleiss' Kappa test for multiple readers.
  • Incidence of adverse events [ Time Frame: Up to 12 months ]
    Safety will be reported descriptively as rates of patient reported adverse events. Additionally, adverse events will be characterized and quantified by Common Terminology Criteria for Adverse Events 4.03.
Original Secondary Outcome Measures  ICMJE Not Provided
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 in Detecting Recurrent Prostate Cancer in Patients After Initial Therapy
Official Title  ICMJE 68Ga-PSMA PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy
Brief Summary This clinical trial studies how well gallium Ga 68-labeled prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) works in detecting prostate cancer that has come back (recurrent) in patients after initial therapy. Diagnostic procedures, such as gallium Ga 68-labeled PSMA-11 PET/CT, may help doctors detect tumors that have come back after initial therapy.
Detailed Description

PRIMARY OBJECTIVE:

I. To assess the sensitivity on a per-patient and per-region-basis of Gallium Ga 68 Gozetotide (68Ga-PSMA-11) PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.

SECONDARY OBJECTIVES:

I. To assess the positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up (composite reference standard).

II. To assess the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy only.

III. To assess the detection rates on a per-patient basis of 68Ga-PSMA-11 PET 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).

IV. To assess the impact of 68Ga-PSMA-11 PET on clinical management in biochemical recurrence (BCR) patients.

V. To assess the inter-reader reproducibility. VI. To assess the safety of 68Ga-PSMA-11 PET. VII. To assess the detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by PSA velocity and PSA doubling-time.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV). Beginning 50-100 minutes after receiving gallium Ga 68-labeled PSMA-11, patients undergo PET imaging.

After completion of study, patients are followed up for 3-12 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Prostate Adenocarcinoma
  • Recurrent Prostate Carcinoma
Intervention  ICMJE
  • Radiation: Gallium Ga 68 Gozetotide
    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)Glu-urea-Lys(Ahx)-HBED-CC
    • 68Ga-DKFZ-PSMA-11
    • 68Ga-HBED-CC-PSMA
    • 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
    • 68Ga-PSMA
    • 68Ga-PSMA-11
    • 68Ga-PSMA-HBED-CC
    • [68Ga] Prostate-specific Membrane Antigen 11
    • [68Ga]GaPSMA-11
    • Ga PSMA
    • Ga-68 labeled DKFZ-PSMA-11
    • Ga-68 labeled PSMA-11
    • Gallium Ga 68 PSMA-11
    • Gallium Ga 68-labeled PSMA-11
    • GALLIUM GA-68 GOZETOTIDE
    • Gallium-68 PSMA
    • Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
    • GaPSMA
    • PSMA-HBED-CC GA-68
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Procedure: Positron Emission Tomography
    Undergo PET imaging
    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: Treatment (68Ga-PSMA-11)
Patients receive gallium Ga 68-labeled PSMA-11 IV. Beginning 50-100 minutes after receiving gallium Ga 68-labeled PSMA-11, patients undergo PET imaging.
Interventions:
  • Radiation: Gallium Ga 68 Gozetotide
  • Other: Laboratory Biomarker Analysis
  • Procedure: Positron Emission Tomography
Publications *

*   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: June 30, 2021)
1138
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2016)
200
Actual Study Completion Date  ICMJE June 18, 2021
Actual Primary Completion Date June 18, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histopathological proven prostate adenocarcinoma
  • Rising PSA after definitive therapy with prostatectomy or radiation therapy.

    • Post radical prostatectomy (RP)

      • PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP
    • Post-radiation therapy - American Society for Therapeutic Radiation and Oncology (ASTRO)-Phoenix consensus definition

      • Nadir + greater than or equal to 2 ng/mL rise in PSA
  • 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:

  • Concomitant investigational therapy
  • Known inability to lie flat, remain still or tolerate a PET scan
  • Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, 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 NCT02940262
Other Study ID Numbers  ICMJE 16-001095
NCI-2016-01212 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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, MD UCLA / Jonsson Comprehensive Cancer Center
PRS Account Jonsson Comprehensive Cancer Center
Verification Date June 2021

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