Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
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.
Other Names:
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
Other Names:
Device: 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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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:
- Patient unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, San Francisco | San Francisco | California | United States | 94143 |
Sponsors and Collaborators
- Thomas Hope
Investigators
- Principal Investigator: Thomas Hope, MD, University of California, San Francisco
Study Documents (Full-Text)
More Information
Publications
None provided.- 185513
- NCI-2019-01394
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Ga-68 Labeled PSMA-11 PET PSMA |
|---|---|
| Arm/Group Description | Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11. |
| Period Title: Overall Study | |
| STARTED | 485 |
| COMPLETED | 484 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Ga-68 Labeled PSMA-11 PET PSMA |
|---|---|
| Arm/Group Description | Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11. |
| Overall Participants | 485 |
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
70.13
|
| Sex: Female, Male (Count of Participants) | |
| Female |
0
0%
|
| Male |
485
100%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
16
3.3%
|
| Not Hispanic or Latino |
441
90.9%
|
| Unknown or Not Reported |
28
5.8%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
26
5.4%
|
| Native Hawaiian or Other Pacific Islander |
3
0.6%
|
| Black or African American |
8
1.6%
|
| White |
408
84.1%
|
| More than one race |
2
0.4%
|
| Unknown or Not Reported |
38
7.8%
|
| Region of Enrollment (participants) [Number] | |
| United States |
485
100%
|
Outcome Measures
| Title | Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group |
|---|---|
| Description | 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. |
| Time Frame | 1 day |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Number Analyzed for each Row indicates the number of participants with each detected level of PSA |
| Arm/Group Title | Ga-68 Labeled PSMA-11 PET PSMA |
|---|---|
| Arm/Group Description | Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11. |
| Measure Participants | 484 |
| PSA Level of 0 to 0.19 |
0.38
|
| PSA Level of 0.2 to 0.49 |
0.45
|
| PSA Level of 0.5 to 0.99 |
0.76
|
| PSA Level of 1 to 1.99 |
0.73
|
| PSA Level of 2 to 4.99 |
0.82
|
| PSA Level of 5 to maximum |
0.62
|
| Title | Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group |
|---|---|
| Description | 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. |
| Time Frame | 1 day |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Number Analyzed for each Row indicates the number of participants with each detected level of PSA |
| Arm/Group Title | Ga-68 Labeled PSMA-11 PET PSMA |
|---|---|
| Arm/Group Description | Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11. |
| Measure Participants | 484 |
| PSA Level of 0 to 0.19 |
0.14
|
| PSA Level of 0.2 to 0.49 |
0.09
|
| PSA Level of 0.5 to 0.99 |
0.18
|
| PSA Level of 1 to 1.99 |
0.37
|
| PSA Level of 2 to 4.99 |
0.50
|
| PSA Level of 5 to maximum |
0.76
|
| Title | Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group |
|---|---|
| Description | 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. |
| Time Frame | 1 day |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Number Analyzed for each Row indicates the number of participants with each detected level of PSA |
| Arm/Group Title | Ga-68 Labeled PSMA-11 PET PSMA |
|---|---|
| Arm/Group Description | Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11. |
| Measure Participants | 484 |
| PSA Level of 0 to 0.19 |
0.10
|
| PSA Level of 0.2 to 0.49 |
0.27
|
| PSA Level of 0.5 to 0.99 |
0.51
|
| PSA Level of 1 to 1.99 |
0.24
|
| PSA Level of 2 to 4.99 |
0.34
|
| PSA Level of 5 to maximum |
0.37
|
| Title | Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group |
|---|---|
| Description | 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. |
| Time Frame | 1 day |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Number Analyzed for each Row indicates the number of participants with each detected level of PSA |
| Arm/Group Title | Ga-68 Labeled PSMA-11 PET PSMA |
|---|---|
| Arm/Group Description | Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11. |
| Measure Participants | 484 |
| PSA Level of 0 to 0.19 |
0.10
|
| PSA Level of 0.2 to 0.49 |
0.09
|
| PSA Level of 0.5 to 0.99 |
0.10
|
| PSA Level of 1 to 1.99 |
0.18
|
| PSA Level of 2 to 4.99 |
0.30
|
| PSA Level of 5 to maximum |
0.21
|
| Title | Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group |
|---|---|
| Description | 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. |
| Time Frame | 1 day |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Number Analyzed for each Row indicates the number of participants with each detected level of PSA |
| Arm/Group Title | Ga-68 Labeled PSMA-11 PET PSMA |
|---|---|
| Arm/Group Description | Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11. |
| Measure Participants | 484 |
| PSA Level of 0 to 0.19 |
0.03
|
| PSA Level of 0.2 to 0.49 |
0.09
|
| PSA Level of 0.5 to 0.99 |
0.18
|
| PSA Level of 1 to 1.99 |
0.22
|
| PSA Level of 2 to 4.99 |
0.25
|
| PSA Level of 5 to maximum |
0.26
|
Adverse Events
| Time Frame | Up to 1 day | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Ga-68 Labeled PSMA-11 PET PSMA | |
| Arm/Group Description | Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11. | |
All Cause Mortality |
||
| Ga-68 Labeled PSMA-11 PET PSMA | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/485 (0%) | |
Serious Adverse Events |
||
| Ga-68 Labeled PSMA-11 PET PSMA | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/485 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Ga-68 Labeled PSMA-11 PET PSMA | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/485 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Thomas Hope, MD |
|---|---|
| Organization | University of California, San Francisco |
| Phone | (415) 221-4810 |
| Thomas.Hope@ucsf.edu |
- 185513
- NCI-2019-01394