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68Ga-PSMA-11 PET/CT in Imaging Patients With Intermediate or High Risk Prostate Cancer Before Surgery

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: NCT03368547
Recruitment Status : Completed
First Posted : December 11, 2017
Last Update Posted : July 7, 2021
Sponsor:
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 imaging patients with intermediate or high risk prostate cancer before surgery. Diagnostic procedures, such as PET/CT scans, may help find and diagnose prostate cancer and find out how far the disease has spread.

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma Stage IIB Prostate Cancer AJCC v7 Stage III Prostate Cancer AJCC v7 Stage IV Prostate Cancer AJCC v7 Procedure: Computed Tomography Radiation: Gallium Ga 68 Gozetotide Procedure: Positron Emission Tomography Not Applicable

Detailed Description:

PRIMARY OBJECTIVE:

I. To assess the sensitivity and specificity of gallium Ga 68 gozetotide (68Ga-PSMA-11) PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis, and on a per patient basis using nodal regional correlation.

SECONDARY OBJECTIVES:

I. To assess the positive and negative predictive value of 68Ga-PSMA-11 PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis, and on a per patient basis using nodal regional correlation.

II. To assess sensitivity, specificity, positive and negative predictive value of 68Ga- PSMA-11 PET for the detection of extra-pelvic nodal metastases, visceral metastases and osseous metastases compared to biopsy and imaging follow-up.

OUTLINE:

Patients receive 68Ga-PSMA-11 intravenously (IV) and undergo PET/CT scan over 20-50 minutes on day 1.

After completion of study, patients are followed up at 2-4 days, then at 12 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1138 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68Ga-PSMA-11 PET/CT for Staging of Intermediate and High Risk Prostate Cancer Prior to Radical Prostatectomy
Actual Study Start Date : December 12, 2016
Actual Primary Completion Date : June 18, 2021
Actual Study Completion Date : June 18, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic (68Ga-PSMA-11, PET/CT)
Patients receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 20-50 minutes on day 1.
Procedure: Computed Tomography
Undergo PET/CT scan
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

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

Procedure: Positron Emission Tomography
Undergo PET/CT scan
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 of 68Ga-PSMA-11 positron emission tomography for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis and using nodal regional correlation [ Time Frame: Up to 12 months ]
    Will be summarized by descriptive statistics.

  2. Specificity of 68Ga-PSMA-11 positron emission tomography for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis and using nodal regional correlation [ Time Frame: Up to 12 months ]
    Will be summarized by descriptive statistics.

  3. Positive predictive value of 68Ga-PSMA-11 positron emission tomography for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis and using nodal regional correlation [ Time Frame: Up to 12 months ]
    Will be summarized by descriptive statistics.

  4. Negative predictive value of 68Ga-PSMA-11 positron emission tomography for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis and using nodal regional correlation [ Time Frame: Up to 12 months ]
    Will be summarized by descriptive statistics.


Secondary Outcome Measures :
  1. Sensitivity of 68Ga-PSMA-11 positron emission tomography for the detection of extra-pelvic nodal metastases, visceral metastases, and osseous metastases compared to biopsy and imaging follow-up [ Time Frame: Up to 12 months ]
    Will be summarized by descriptive statistics.

  2. Specificity of 68Ga-PSMA-11 positron emission tomography for the detection of extra-pelvic nodal metastases, visceral metastases, and osseous metastases compared to biopsy and imaging follow-up [ Time Frame: Up to 12 months ]
    Will be summarized by descriptive statistics.

  3. Positive predictive value of 68Ga-PSMA-11 positron emission tomography for the detection of extra-pelvic nodal metastases, visceral metastases, and osseous metastases compared to biopsy and imaging follow-up [ Time Frame: Up to 12 months ]
    Will be summarized by descriptive statistics.

  4. Negative predictive value of 68Ga-PSMA-11 positron emission tomography for the detection of extra-pelvic nodal metastases, visceral metastases, and osseous metastases compared to biopsy and imaging follow-up [ Time Frame: Up to 12 months ]
    Will be summarized by descriptive statistics.


Other Outcome Measures:
  1. Sensitivity for detection of regional nodal metastases in comparison to cross sectional imaging performed contemporaneously with the 68Ga-PSMA-11 positron emission tomography [ Time Frame: Up to 12 months ]
    Will be summarized by descriptive statistics.

  2. Specificity for detection of regional nodal metastases in comparison to cross sectional imaging performed contemporaneously with the 68Ga-PSMA-11 positron emission tomography [ Time Frame: Up to 12 months ]
    Will be summarized by descriptive statistics.

  3. Positive predictive value for detection of regional nodal metastases in comparison to cross sectional imaging performed contemporaneously with the 68Ga-PSMA-11 positron emission tomography [ Time Frame: Up to 12 months ]
    Will be summarized by descriptive statistics.

  4. Negative predictive value for detection of regional nodal metastases in comparison to cross sectional imaging performed contemporaneously with the 68Ga-PSMA-11 positron emission tomography [ Time Frame: Up to 12 months ]
    Will be summarized by descriptive statistics.

  5. PSA progression free survival [ Time Frame: Up to 1 year ]
    Will compare patients with and without pelvic nodal metastases.

  6. Standardized uptake value maximum and short axis diameter of nodal disease on cross sectional imaging correlated to presence of true pathology [ Time Frame: Up to 12 months ]
  7. Incidence of osseous and distant metastatic lesions [ Time Frame: Up to 12 months ]
  8. Impact of 68Ga-PSMA-11 positron emission tomography on clinical management [ Time Frame: Up to 12 months ]
  9. Incidence of adverse events [ Time Frame: Up to 3 days ]
    Assessed per Common Terminology Criteria for Adverse Events version 4.03.

  10. Inter-reader reproducibility [ Time Frame: Up to 12 months ]
  11. Sensitivity and specificity on lesions level for 68Ga-PSMA-11 positron emission tomography and multiparametric magnetic resonance imaging [ Time Frame: Up to 12 months ]
  12. Quantitative parameters for malignant and benign lesions (BPH, hgPIN, inflammation) in 68Ga-PSMA-11 positron emission tomography and multiparametric magnetic resonance imaging [ Time Frame: Up to 12 months ]
  13. Gross-tumor-volume using 68Ga-PSMA-11 positron emission tomography and multiparametric magnetic resonance imaging [ Time Frame: Up to 12 months ]
    Will be compared to tumor extent in histopathology.

  14. Lesional standardized uptake value maximum from 68Ga-PSMA-11 [ Time Frame: Up to 12 months ]
    Will be correlated with immunohistochemical stainings (e.g. PSMA, PI3K, Akt) and Gleason score.



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

Inclusion Criteria:

  • Biopsy proven prostate adenocarcinoma
  • Considered for prostatectomy with lymph node dissection
  • Intermediate to high-risk disease (as determined by elevated prostate specific antigen [PSA] [PSA > 10], tumor [T]-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors)
  • Able to provide written consent
  • Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)

Exclusion Criteria:

  • Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
  • Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (high-intensity focused ultrasound ablation [HiFu])

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): NCT03368547


Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: Johannes Czernin UCLA / Jonsson Comprehensive Cancer Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03368547    
Other Study ID Numbers: 16-001684
NCI-2016-01768 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Edetic Acid
Gallium 68 PSMA-11
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Calcium Chelating Agents
Radiopharmaceuticals