Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients
2 other identifiers
interventional
485
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 prostate-cancer
Started Oct 2018
Shorter than P25 for phase_3 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 11, 2018
CompletedFirst Submitted
Initial submission to the registry
January 10, 2019
CompletedFirst Posted
Study publicly available on registry
January 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2020
CompletedResults Posted
Study results publicly available
August 24, 2021
CompletedAugust 24, 2021
July 1, 2021
1.9 years
January 10, 2019
July 8, 2021
July 31, 2021
Conditions
Outcome Measures
Primary Outcomes (5)
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
Study Arms (1)
Ga-68 labeled PSMA-11 PET PSMA
EXPERIMENTALThe 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.
Interventions
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.
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
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \. Patient unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thomas Hopelead
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Thomas Hope, MD
- Organization
- University of California, San Francisco
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Hope, MD
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 10, 2019
First Posted
January 14, 2019
Study Start
October 11, 2018
Primary Completion
August 25, 2020
Study Completion
August 25, 2020
Last Updated
August 24, 2021
Results First Posted
August 24, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share