Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Thomas Hope
- Enrollment
- 485
- Locations
- 1
- Primary Endpoint
- Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male, age >=
- •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
- •Patient unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.
Arms & Interventions
Ga-68 labeled PSMA-11 PET PSMA
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.
Intervention: Ga-68 labeled PSMA-11 (Drug)
Ga-68 labeled PSMA-11 PET PSMA
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.
Intervention: Positron emission tomography-computed tomography (PET/CT) (Device)
Ga-68 labeled PSMA-11 PET PSMA
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.
Intervention: Positron emission tomography-magnetic resonance imaging (PET/MRI) (Device)
Outcomes
Primary Outcomes
Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group
Time Frame: 1 day
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.
Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group
Time Frame: 1 day
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.
Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group
Time Frame: 1 day
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.
Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group
Time Frame: 1 day
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.
Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group
Time Frame: 1 day
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Thomas Hope
Principal Investigator
University of California, San Francisco