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Trial record 39 of 245 for:    cardiac CT OR CAT scan OR coronary artery scan | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

68Ga-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 : November 14, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:
This clinical trial studies how well 68Ga-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 68Ga-PSMA-11PET/CT, may help doctors detect tumors that have come back after initial therapy.

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma Recurrent Prostate Carcinoma Device: Computed Tomography Radiation: Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC Other: Laboratory Biomarker Analysis Device: Positron Emission Tomography Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate 68gallium (Ga)-prostate-specific membrane antigen (PSMA) PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated PSA and non-contributory bone scintigraphy, computed tomography (CT) or magnetic resonance imaging (MRI).

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA ligand glutamic acid (Glu)-urea-lysine (Lys)(Ahx) intravenously (IV) and after 45-60 minutes undergo PET/CT.

After completion of study, patients are followed up every 3-6 months for up to 1 year.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment (68Ga-PSMA-11)
Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and after 45-60 minutes undergo PET/CT.
Device: Computed Tomography
Undergo PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography
Radiation: Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
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
  • Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • PSMA-HBED-CC GA-68
Other: Laboratory Biomarker Analysis
Correlative studies
Device: 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



Primary Outcome Measures :
  1. Diagnostic performance of 68Ga-PSMA-11 PET/CT assessed by detected lesion [ Time Frame: Up to 1 year ]
    Patients receive gallium Ga 68-labeled PSMA ligand glutamic acid (Glu)-urea-lysine (Lys)(Ahx) intravenously (IV) and after 45-60 minutes undergo PET/CT. After completion of study, patients are followed up every 3-6 months for up to 1 year.



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

Inclusion Criteria:

  1. Histopathological proven prostate adenocarcinoma.
  2. Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

    a. Post radical prostatectomy (RP) - AUA recommendation i. PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and, ii. Confirmatory persistent PSA greater than 0.2 ng/mL b. Post-radiation therapy -ASTRO-Phoenix consensus definition i. Nadir + greater than or equal to 2 ng/mL rise in PSA

  3. Able to provide written consent.
  4. Karnofsky performance status of 50 (or ECOG/WHO equivalent).

Exclusion Criteria:

  1. Investigational therapy for prostate cancer.
  2. Unable to lie flat, still or tolerate a PET scan.
  3. Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
  4. Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).

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

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: November 14, 2017
Last Verified: November 2017

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
Edetic Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action