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

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ClinicalTrials.gov Identifier: NCT03368547
Recruitment Status : Active, not recruiting
First Posted : December 11, 2017
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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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-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 ligand Glu-urea-Lys(Ahx)-HBED-CC (68Ga-PSMA-11) PET/CT for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis.

OUTLINE:

Patients receive 68Ga-PSMA-11 intravenously (IV) and undergo a single PET/CT scan over 45-60 minutes at week 1.

After completion of study, patients are followed up at 1-3 days.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 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
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Diagnostic (68Ga-PSMA-11, PET/CT)
Patients receive 68Ga-PSMA-11 IV and undergo a single PET/CT scan over 45-60 minutes at week 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-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 scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • positron emission tomography scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Other Outcome Measures:
  1. 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.

  2. Impact of 68Ga-PSMA-11 positron emission tomography on clinical management [ Time Frame: Up to 12 months ]
  3. Incidence of adverse events [ Time Frame: Up to 3 days ]
  4. Incidence of osseous and distant metastatic lesions [ Time Frame: Up to 12 months ]
  5. Inter-reader agreement of 68Ga-PSMA-11 PET/CT [ Time Frame: Up to 12 months ]
    Cohen's kappa coefficient, Fleiss' kappa coefficient

  6. 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.

  7. 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.

  8. 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.

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

  10. Sensitivity and specificity on lesions level for 68Ga-PSMA-11 positron emission tomography and multiparametric magnetic resonance imaging [ Time Frame: Up to 12 months ]
  11. 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.

  12. 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.

  13. Comparison of radiotherapy gross-target-volume (GTV) using 68Ga-PSMA-11 PET and mpMRI to tumor extent in histopathology [ Time Frame: Up to 12 months ]

Eligibility Criteria
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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
  • Planned 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)
  • Diagnostic CT or magnetic resonance imaging (MRI) as part of the PET study or performed within one month of PSMA PET

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])
Contacts and Locations
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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
More Information
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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) )
16-001684 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
NCI-2016-01768 ( Registry Identifier: CTRP )
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
 Edetic Acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Calcium Chelating Agents