Metastasis From Malignant Tumor of Prostate (Disorder)
Conditions
Keywords
PSMA, Prostate Cancer, PET, SOLAR, Cu-64 PSMA
Brief summary
This is a prospective, open-label Phase 2 study to evaluate copper Cu 64 PSMA I&T injection for PET/CT imaging in patients with recurrent metastatic prostate cancer after radical prostatectomy or radiation therapy.
Detailed description
The study will include a group of 26 patients with metastatic prostate cancer. Each patient will be administered a 7-9 mCi intravenous dose of copper Cu 64 PSMA I&T injection. PET/CT images will be acquired for all patients at 1 hour ± 15 minutes and 4 hours ± 30 minutes post copper Cu 64 PSMA I&T injection. The PET/CT images will be interpreted independently by three readers blinded to all patient information. Each patient study will be assessed and scored for the detection of prostate cancer. Specifically, each reader will categorize images as Disease or No Disease based only on tumor uptake of copper Cu 64 PSMA-I&T in each of the four regions: 1) prostate bed or prostate gland, 2) lymph nodes (pelvic and extra pelvic), 3) bone, and 4) viscera/soft tissue. Analysis of the reads will be used for determination of the CLR and CDR for 1 hour and 4-hour post-injection imaging of copper Cu 64 PSMA I&T PET/CT by comparison to the Composite Reference Standard.
Interventions
DRUG64Cu-PSMA I&T
Radiolabeled Receptor-Targeted Diagnostic Product
Sponsors
Curium US LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with histologically proven prostate adenocarcinoma. 2. Prior radical prostatectomy or radiation therapy with curative intent. 3. Recurrence of disease defined as: 1. Prior Radical Prostatectomy: PSA \> 0.2 ng/mL, or 2. Prior Radiation Therapy: 2 ng/mL rise in PSA over post-treatment nadir 4. Patients with at least one extraprostatic site of disease suspected based on prior imaging or diagnosed by biopsy. 5. Age greater than or equal to 18 years. 6. Able to understand and provide signed written informed consent.
Exclusion criteria
1. Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway, unless subject has a rising PSA level. 2. Body weight greater than 350 lb (158 kg). 3. Investigational therapy within the past 30 days. 4. Creatinine clearance (ClCr) less than 30 mL/min. 5. Participants who are capable of fathering a child and who are unwilling to take precautions to prevent pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Region-Level Correct Localization Rate (CLR) | 4 Hours | To determine the region-level correct localization rate (CLR) of copper Cu 64 PSMA I&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer at 1 hour and 4 hours post injection. The CLR is defined as the percentage of regions containing at least one true PET positive lesion, with exactly localized correspondence between PET/CT imaging and the Composite Reference Standard regardless of any co-existent false positive findings, within the same region, out of all regions containing at least one PET positive finding. |
| Patient-Level Correct Detection Rate (CDR) | 4 Hours | To determine the patient-level correct detection rate (CDR) of copper Cu 64 PSMA I&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer at 1 hour and 4 hours post injection. The CDR is defined as the percentage of patients who have at least one true PET positive lesion, with exactly localized correspondence between PET imaging and the Composite Reference Standard, regardless of any co-existent false positive findings, out of all patients who are scanned. |
| Incidence of Adverse Events | 24 Hours | Adverse events (AEs) were assessed from the time of copper Cu 64 PSMA I&T injection throughout the24-hour assessment period. AEs were assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score of Image Quality | 4 Hours | To compare the diagnostic quality of PET/CT images obtained at 1 hour and 4 hours post copper Cu 64 PSMA I&T injection. Image quality score is based on a scale of 0-2 where 0 is not of diagnostic quality and 2 is of best diagnostic quality. |
Countries
United States
Participant flow
Recruitment details
The study was conducted in 9 sites across USA, Recruitment was initiated on 30 November, 2022 and was closed on 17 May 2023.
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic Imaging With 64Cu-PSMA-I&T 64Cu-PSMA I&T: Radiolabeled Receptor-Targeted Diagnostic Product | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | Diagnostic Imaging With 64Cu-PSMA-I&T |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 71.1 years STANDARD_DEVIATION 7.73 |
| Body Mass Index (BMI) | 29.43 kg/m^2 STANDARD_DEVIATION 4.544 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Height | 176.0 CM STANDARD_DEVIATION 6.45 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 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 | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 26 Participants |
| Weight | 91.3 KG STANDARD_DEVIATION 15.87 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
Incidence of Adverse Events
Adverse events (AEs) were assessed from the time of copper Cu 64 PSMA I&T injection throughout the24-hour assessment period. AEs were assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: 24 Hours
Population: All 26 patients were analyzed for Adverse Events through the monitoring of clinical and laboratory safety parameters.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Diagnostic Imaging With 64Cu-PSMA-I&T | Incidence of Adverse Events | Adverse Events (AEs) | 3 Participants |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Incidence of Adverse Events | Serious Adverse Events (SAEs) | 0 Participants |
Primary
Patient-Level Correct Detection Rate (CDR)
To determine the patient-level correct detection rate (CDR) of copper Cu 64 PSMA I&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer at 1 hour and 4 hours post injection. The CDR is defined as the percentage of patients who have at least one true PET positive lesion, with exactly localized correspondence between PET imaging and the Composite Reference Standard, regardless of any co-existent false positive findings, out of all patients who are scanned.
Time frame: 4 Hours
Population: The PET/CT images were acquired for all 26 patients at 1 hour and 4 hours post copper Cu 64 PSMA I\&T injection and interpreted independently by 3 readers blinded to clinical information and findings on the composite reference standard.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diagnostic Imaging With 64Cu-PSMA-I&T | Patient-Level Correct Detection Rate (CDR) | Reader 1 (1-Hour Image) | 84.21 percentage of Patients |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Patient-Level Correct Detection Rate (CDR) | Reader 1 (4-Hour Image) | 84.21 percentage of Patients |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Patient-Level Correct Detection Rate (CDR) | Reader 2 (1-Hour Image) | 77.19 percentage of Patients |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Patient-Level Correct Detection Rate (CDR) | Reader 2 (4-Hour Image) | 79.82 percentage of Patients |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Patient-Level Correct Detection Rate (CDR) | Reader 3 (1-Hour Image) | 80.70 percentage of Patients |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Patient-Level Correct Detection Rate (CDR) | Reader 3 (4-Hour Image) | 80.70 percentage of Patients |
Primary
Region-Level Correct Localization Rate (CLR)
To determine the region-level correct localization rate (CLR) of copper Cu 64 PSMA I&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer at 1 hour and 4 hours post injection. The CLR is defined as the percentage of regions containing at least one true PET positive lesion, with exactly localized correspondence between PET/CT imaging and the Composite Reference Standard regardless of any co-existent false positive findings, within the same region, out of all regions containing at least one PET positive finding.
Time frame: 4 Hours
Population: The PET/CT images were acquired for all 26 patients at 1 hour and 4 hours post copper Cu 64 PSMA I\&T injection and interpreted independently by 3 readers blinded to clinical information and findings on the composite reference standard.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Diagnostic Imaging With 64Cu-PSMA-I&T | Region-Level Correct Localization Rate (CLR) | Reader 1 (1-Hour Image) | 86.67 percentage of Regions |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Region-Level Correct Localization Rate (CLR) | Reader 1 (4-Hour Image) | 86.67 percentage of Regions |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Region-Level Correct Localization Rate (CLR) | Reader 2 (1-Hour Image) | 76.67 percentage of Regions |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Region-Level Correct Localization Rate (CLR) | Reader 2 (4-Hour Image) | 80.00 percentage of Regions |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Region-Level Correct Localization Rate (CLR) | Reader 3 (1-Hour Image) | 80.00 percentage of Regions |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Region-Level Correct Localization Rate (CLR) | Reader 3 (4-Hour Image) | 80.00 percentage of Regions |
Secondary
Score of Image Quality
To compare the diagnostic quality of PET/CT images obtained at 1 hour and 4 hours post copper Cu 64 PSMA I&T injection. Image quality score is based on a scale of 0-2 where 0 is not of diagnostic quality and 2 is of best diagnostic quality.
Time frame: 4 Hours
Population: The PET/CT images were acquired for all 26 patients at 1 hour and 4 hours post copper Cu 64 PSMA I\&T injection and interpreted independently by 3 readers blinded to clinical information and findings on the composite reference standard.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Diagnostic Imaging With 64Cu-PSMA-I&T | Score of Image Quality | Reader 1 (1-Hour Post Dose) | Inadequate | 0 Participants |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Score of Image Quality | Reader 1 (1-Hour Post Dose) | Questionable | 0 Participants |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Score of Image Quality | Reader 1 (1-Hour Post Dose) | Acceptable | 26 Participants |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Score of Image Quality | Reader 1 (4-Hour Post Dose) | Inadequate | 0 Participants |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Score of Image Quality | Reader 1 (4-Hour Post Dose) | Questionable | 0 Participants |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Score of Image Quality | Reader 1 (4-Hour Post Dose) | Acceptable | 26 Participants |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Score of Image Quality | Reader 2 (1-Hour Post Dose) | Inadequate | 0 Participants |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Score of Image Quality | Reader 2 (1-Hour Post Dose) | Questionable | 2 Participants |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Score of Image Quality | Reader 2 (1-Hour Post Dose) | Acceptable | 24 Participants |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Score of Image Quality | Reader 2 (4-Hour Post Dose) | Inadequate | 0 Participants |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Score of Image Quality | Reader 2 (4-Hour Post Dose) | Questionable | 0 Participants |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Score of Image Quality | Reader 2 (4-Hour Post Dose) | Acceptable | 26 Participants |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Score of Image Quality | Reader 3 (1-Hour Post Dose) | Inadequate | 0 Participants |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Score of Image Quality | Reader 3 (1-Hour Post Dose) | Questionable | 0 Participants |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Score of Image Quality | Reader 3 (1-Hour Post Dose) | Acceptable | 26 Participants |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Score of Image Quality | Reader 3 (4-Hour Post Dose) | Inadequate | 0 Participants |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Score of Image Quality | Reader 3 (4-Hour Post Dose) | Questionable | 0 Participants |
| Diagnostic Imaging With 64Cu-PSMA-I&T | Score of Image Quality | Reader 3 (4-Hour Post Dose) | Acceptable | 26 Participants |