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

Phase 3

Completed

Conditions: Prostate Cancer

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

Registration Number: NCT03803475

Lead Sponsor: Thomas Hope

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 485

Inclusion Criteria

Male, age >= 18.
Histopathologically proven prostate adenocarcinoma.
Concern for metastatic disease in one of the following settings:
1. Initial staging with intermediate to high risk prostate cancer.
2. 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ga-68 labeled PSMA-11 PET PSMA	Positron emission tomography-computed tomography (PET/CT)	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.
Ga-68 labeled PSMA-11 PET PSMA	Positron emission tomography-magnetic resonance imaging (PET/MRI)	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.
Ga-68 labeled PSMA-11 PET PSMA	Ga-68 labeled PSMA-11	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.

Primary Outcome Measures

Name	Time	Method
Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group	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	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	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	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	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.