Prostate Adenocarcinoma, Prostate Cancer
Conditions
Keywords
Newly Diagnosed
Brief summary
Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.
Detailed description
This is a prospective, Phase III, single-center, open-label to provide extended access in patients with biochemically recurrent prostate cancer. Approximately 100 patients are planned for enrollment in this study. Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study. The intervention is a PET scan with the radiolabelled Prostate-specific membrane antifen (PSMA) ligand, 68Ga-PSMA-11. The PET may be combined with a CT scan as a PET/CT or an MRI scan as PET/MRI. 68Ga-PSMA-11 PET/CT will be acquired using a modern digital GE PET/CT scanner or a modern digital PET / MRI scanner. AEs will be collected during injection and uptake phase (45-120 min posts infusion) of Ga-68 PSMA-11 PET/CT scan. All safety events will be recorded up to 120 min post injection. Men with pathologically proven prostate adenocarcinoma, high risk cancer at diagnosis, evidence of biochemical recurrence, or known metastatic disease planned to start and change systemic therapy regimen. One intravenous catheter will be placed for radiopharmaceutical administration. Patients will be injected with 100 MBq (3mCi)-300 MBq( 7mCi) of 68Ga-PSMA-11 via this catheter.
Interventions
DRUGGa-PSMA-11
The PSMA Sterile Cold Kit, is a kit comprising all needed materials (lyophilized PSMA for PSMA reconstitution, elution vial for Ga and ancillary materials for transfer between vials) to perform a room-temperature radiolabelling of PSMA-11 with Ga. Ga is not part of the kit and should be provided in the form gallium chloride solution following the requirements of the relevant local regulations. PSMA-11 radiolabelled with Ga is administered in patients with prostate cancer recurrence after radical treatment.
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Histopathologically proven prostate adenocarcinoma * Age ≥ 18 years * Patients already diagnosed with prostate cancer: Primary Staging: intermediate and high-risk patients per NCCN guidelines * Biochemical Recurrence: Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy): a. Post radical prostatectomy (RP) - AUA recommendation i. PSA greater than or equal to 0.2 ng/mL measured more than 6-13 weeks after RP and confirmed by a second determination of a PSA level of \>0.2 ng/mL b. Post-radiation therapy - ASTRO-Phoenix consensus definition i. Nadir + greater than or equal to 2 ng/mL rise in PSA * Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion criteria
* Unable to lie flat, still or tolerate a PET/CT scan, or any other condition that would preclude PET/CT imaging. * Patients with any medical condition or circumstance that the investigator believes may compromise the data collection or lead to a failure to fulfil the study requirements. * Patients with known hypersensitivity to the active substance or to any of the excipients of the investigational product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | Immediately after administration and for 1 hour and 30 minutes afterwards | Adverse Events (AEs) will be collected and reviewed to monitor for safety. Incidence and severity of AEs and adverse events will be estimated with 95% confidence intervals summarized with descriptive statistics. CTCAE version 5.0 will be used to grade AEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the Diagnostic Impact of 68Ga-PSMA-11 PET/CT Imaging Over Current Standard of Care Imaging Modalities. | 2 hours | Determine the frequency of positive PSMA PET scans in relation to the PSA value before the PSMA scans and compared to conventional imaging. Results will be summarized descriptively with 95% confidence intervals. Determine rate of overall changes in management by comparing planned management strategy using conventional imaging with executed management strategy incorporating information from 68Ga-PSMA-11 PET/CT, regardless of treatment modality. Analysis: The rate of change in management based on the incorporation of68Ga-PSMA-11 PET/CT results will be expressed as the percentage of total patients imaged in which change in management occurred, regardless of treatment modality. The rate of change in management will also be estimated within each group (initial staging, biochemical recurrence, and pre/post treatment). 95% confidence intervals (CIs) will be used to express precision of the estimates. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Men With Pathologically Proven Prostate Adenocarcinoma The intervention is a PET scan with the radiolabelled PSMA ligand, 68Ga-PSMA-11. The PET may be combined with a CT scan as a PET/CT or an MRI scan as PET/MRI. 68Ga-PSMA-11 PET/CT will be acquired using a modern digital GE PET/CT scanner or a modern digital PET / MRI scanner.
Ga-PSMA-11: The PSMA Sterile Cold Kit, is a kit comprising all needed materials (lyophilized PSMA for PSMA reconstitution, elution vial for Ga and ancillary materials for transfer between vials) to perform a room-temperature radiolabelling of PSMA-11 with Ga. Ga is not part of the kit and should be provided in the form gallium chloride solution following the requirements of the relevant local regulations. PSMA-11 radiolabelled with Ga is administered in patients with prostate cancer recurrence after radical treatment. | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | Men With Pathologically Proven Prostate Adenocarcinoma |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 26 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 68.7 years STANDARD_DEVIATION 12.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 39 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 39 |
| other Total, other adverse events | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
Primary
Number of Participants With Adverse Events
Adverse Events (AEs) will be collected and reviewed to monitor for safety. Incidence and severity of AEs and adverse events will be estimated with 95% confidence intervals summarized with descriptive statistics. CTCAE version 5.0 will be used to grade AEs.
Time frame: Immediately after administration and for 1 hour and 30 minutes afterwards
Population: All patients observed for safety.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adverse Events- All Grades | Number of Participants With Adverse Events | 0 Participants |
Secondary
Compare the Diagnostic Impact of 68Ga-PSMA-11 PET/CT Imaging Over Current Standard of Care Imaging Modalities.
Determine the frequency of positive PSMA PET scans in relation to the PSA value before the PSMA scans and compared to conventional imaging. Results will be summarized descriptively with 95% confidence intervals. Determine rate of overall changes in management by comparing planned management strategy using conventional imaging with executed management strategy incorporating information from 68Ga-PSMA-11 PET/CT, regardless of treatment modality. Analysis: The rate of change in management based on the incorporation of68Ga-PSMA-11 PET/CT results will be expressed as the percentage of total patients imaged in which change in management occurred, regardless of treatment modality. The rate of change in management will also be estimated within each group (initial staging, biochemical recurrence, and pre/post treatment). 95% confidence intervals (CIs) will be used to express precision of the estimates.
Time frame: 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adverse Events- All Grades | Compare the Diagnostic Impact of 68Ga-PSMA-11 PET/CT Imaging Over Current Standard of Care Imaging Modalities. | 12 Participants |
| Initial Treatment Strategy Group- Patient Management | Compare the Diagnostic Impact of 68Ga-PSMA-11 PET/CT Imaging Over Current Standard of Care Imaging Modalities. | 1 Participants |
| Subsequent Treatment Strategy Group | Compare the Diagnostic Impact of 68Ga-PSMA-11 PET/CT Imaging Over Current Standard of Care Imaging Modalities. | 22 Participants |
| Subsequent Treatment Strategy Group- Patient Management | Compare the Diagnostic Impact of 68Ga-PSMA-11 PET/CT Imaging Over Current Standard of Care Imaging Modalities. | 21 Participants |
| All Participants- Initial and Subsequent Strategy | Compare the Diagnostic Impact of 68Ga-PSMA-11 PET/CT Imaging Over Current Standard of Care Imaging Modalities. | 7 Participants |