68Ga-PSMA-11 PET/CT in Imaging Patients With Intermediate or High Risk Prostate Cancer Before Surgery
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVE:
- 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:
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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.
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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.
Study Design
Arms and Interventions
| 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:
Radiation: Gallium Ga 68 Gozetotide
Given IV
Other Names:
Procedure: Positron Emission Tomography
Undergo PET/CT scan
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 [Up to 12 months]
Will be summarized by descriptive statistics.
- 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 [Up to 12 months]
Will be summarized by descriptive statistics.
- 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 [Up to 12 months]
Will be summarized by descriptive statistics.
- 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 [Up to 12 months]
Will be summarized by descriptive statistics.
Secondary Outcome Measures
- 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 [Up to 12 months]
Will be summarized by descriptive statistics.
- 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 [Up to 12 months]
Will be summarized by descriptive statistics.
- 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 [Up to 12 months]
Will be summarized by descriptive statistics.
- 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 [Up to 12 months]
Will be summarized by descriptive statistics.
Other Outcome Measures
- Sensitivity for detection of regional nodal metastases in comparison to cross sectional imaging performed contemporaneously with the 68Ga-PSMA-11 positron emission tomography [Up to 12 months]
Will be summarized by descriptive statistics.
- Specificity for detection of regional nodal metastases in comparison to cross sectional imaging performed contemporaneously with the 68Ga-PSMA-11 positron emission tomography [Up to 12 months]
Will be summarized by descriptive statistics.
- 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 [Up to 12 months]
Will be summarized by descriptive statistics.
- 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 [Up to 12 months]
Will be summarized by descriptive statistics.
- PSA progression free survival [Up to 1 year]
Will compare patients with and without pelvic nodal metastases.
- Standardized uptake value maximum and short axis diameter of nodal disease on cross sectional imaging correlated to presence of true pathology [Up to 12 months]
- Incidence of osseous and distant metastatic lesions [Up to 12 months]
- Impact of 68Ga-PSMA-11 positron emission tomography on clinical management [Up to 12 months]
- Incidence of adverse events [Up to 3 days]
Assessed per Common Terminology Criteria for Adverse Events version 4.03.
- Inter-reader reproducibility [Up to 12 months]
- Sensitivity and specificity on lesions level for 68Ga-PSMA-11 positron emission tomography and multiparametric magnetic resonance imaging [Up to 12 months]
- Quantitative parameters for malignant and benign lesions (BPH, hgPIN, inflammation) in 68Ga-PSMA-11 positron emission tomography and multiparametric magnetic resonance imaging [Up to 12 months]
- Gross-tumor-volume using 68Ga-PSMA-11 positron emission tomography and multiparametric magnetic resonance imaging [Up to 12 months]
Will be compared to tumor extent in histopathology.
- Lesional standardized uptake value maximum from 68Ga-PSMA-11 [Up to 12 months]
Will be correlated with immunohistochemical stainings (e.g. PSMA, PI3K, Akt) and Gleason score.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Biopsy proven prostate adenocarcinoma
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Considered for prostatectomy with lymph node dissection
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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)
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Able to provide written consent
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Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)
Exclusion Criteria:
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Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
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Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (high-intensity focused ultrasound ablation [HiFu])
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | United States | 90095 |
Sponsors and Collaborators
- Jonsson Comprehensive Cancer Center
Investigators
- Principal Investigator: Johannes Czernin, UCLA / Jonsson Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16-001684
- NCI-2016-01768