Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients

Study Overview
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Brief Summary
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The investigators are imaging patients with prostate cancer using a new Positron Emission Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect prostate cancer.

Detailed Description
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Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. PET imaging will begin 50-100 minutes after injection, but may be possible in certain circumstances for imaging to be delayed due to patient workflow or equipment issues Primary Objective: Sensitivity on a per-patient and per-region-basis (Table 1) of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.

Official Title
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Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Ga-68 labeled PSMA-11
* Device: Positron emission tomography-computed tomography (PET/CT)
* Device: Positron emission tomography-magnetic resonance imaging (PET/MRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male, age >= 18. Histopathologically proven prostate adenocarcinoma. Concern for metastatic disease in one of the following settings: Initial staging with intermediate to high risk prostate cancer. Biochemical recurrence after initial therapy. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: 1. Patient unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ga-68 labeled PSMA-11 PET PSMA<br>The imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET imaging. The injected dose will be 3 to 7 millicurie (mCi) +/- 10% of 68Ga-PSMA-11. | Drug: Ga-68 labeled PSMA-11<br>* Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.<br>* Other names: Ga-68 labeled HBED-CC PSMA;Device: Positron emission tomography-computed tomography (PET/CT)<br>* Positron emission tomography-computed tomography (PET/CT) is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography (PET) scanner and an x-ray computed tomography (CT) scanner, to acquire sequential images from both devices in the same session<br>* Other names: PET-CT;Device: Positron emission tomography-magnetic resonance imaging (PET/MRI)<br>* A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan in a single session<br>* Other names: PET-MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group | Detection rate is defined as the proportion of all patients who have prostate cancer and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging. | 1 day | 
| Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group | Detection rate is defined as the proportion of all patients who have prostate cancer located in the prostate bed and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging. | 1 day | 
| Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group | Detection rate is defined as the proportion of all patients who have prostate cancer located in the pelvic nodes and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging. | 1 day | 
| Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group | Detection rate is defined as the proportion of all patients who have prostate cancer located in the distant soft tissues and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging. | 1 day | 
| Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group | Detection rate is defined as the proportion of all patients who have prostate cancer located in the bone (osseous lesions) and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging. | 1 day |