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

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ClinicalTrials.gov Identifier: NCT02940262
Recruitment Status : Recruiting
First Posted : October 20, 2016
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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 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.

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma PSA Progression Recurrent Prostate Carcinoma Radiation: Gallium Ga 68-labeled PSMA-11 Other: Laboratory Biomarker Analysis Procedure: Positron Emission Tomography Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate gallium Ga 68-labeled PSMA-11 PET whole body imaging for detection of disease recurrence in clinically relevant anatomic regions.

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68Ga-PSMA PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy
Actual Study Start Date : September 5, 2016
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Gallium

Arm Intervention/treatment
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.
Radiation: 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 imaging
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. Sensitivity on a per-patient and per-region-basis of gallium Ga 68-labeled PSMA-11 positron emission tomography for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up [ Time Frame: Up to 12 months ]
    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.


Secondary Outcome Measures :
  1. Clinical management in biochemical recurrence patients [ Time Frame: Up to 12 months ]
    Clinical management will be recorded with referring physician's questionnaires (outcome measure) before PSMA PET/CT, just after PSMA PET/CT and 6 months after PSMA PET/CT. 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.

  2. Detection rates on a per-patient basis of gallium Ga 68-labeled PSMA-11 positron emission tomography stratified by PSA (prostate specific antigen) 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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 confirmed by histopathology/biopsy and, clinical and conventional imaging follow-up [ Time Frame: Up to 12 months ]
    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.

  7. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  • Unable to lie flat, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940262


Locations
United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Johannes Czernin    310-206-3226      
Principal Investigator: Johannes Czernin         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Johannes Czernin UCLA / Jonsson Comprehensive Cancer Center

Publications:
Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02940262     History of Changes
Other Study ID Numbers: 16-001095
NCI-2016-01212 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
16-001095 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
P30CA016042 ( U.S. NIH Grant/Contract )
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type