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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03803475
• Other study ID #: 185513
• Secondary ID: NCI-2019-01394
• Status: Completed
• Phase: Phase 3
• Start date: October 11, 2018
• Est. completion date: August 25, 2020

Study information

• Verified date: July 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 485
• Est. completion date: August 25, 2020
• Est. primary completion date: August 25, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male, age >= 18.

2. Histopathologically proven prostate adenocarcinoma.

3. 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.

4. 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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Ga-68 labeled PSMA-11
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.

Device:
• Positron emission tomography-computed tomography (PET/CT)
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
• Positron emission tomography-magnetic resonance imaging (PET/MRI)
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

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Hope

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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