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 :
Completed
First Posted : December 11, 2017
Last Update Posted : July 7, 2021
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Condition or disease | Intervention/treatment | Phase |
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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 |
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.
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 |

Arm | Intervention/treatment |
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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.
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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:
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- PSA progression free survival [ Time Frame: 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 [ Time Frame: Up to 12 months ]
- Incidence of osseous and distant metastatic lesions [ Time Frame: Up to 12 months ]
- Impact of 68Ga-PSMA-11 positron emission tomography on clinical management [ Time Frame: Up to 12 months ]
- Incidence of adverse events [ Time Frame: Up to 3 days ]Assessed per Common Terminology Criteria for Adverse Events version 4.03.
- Inter-reader reproducibility [ Time Frame: Up to 12 months ]
- Sensitivity and specificity on lesions level for 68Ga-PSMA-11 positron emission tomography and multiparametric magnetic resonance imaging [ Time Frame: 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 [ Time Frame: Up to 12 months ]
- 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.
- 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 |
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])

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
United States, California | |
UCLA / Jonsson Comprehensive Cancer Center | |
Los Angeles, California, United States, 90095 |
Principal Investigator: | Johannes Czernin | UCLA / Jonsson Comprehensive Cancer Center |
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 |
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 |