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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic Imaging with 64Cu-PSMA-I&T | Experimental | 64Cu-PSMA I&T |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 64Cu-PSMA I&T | Drug | Radiolabeled Receptor-Targeted Diagnostic Product |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 Hours |
| 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. | 4 Hours |
| 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. | 24 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 Hours |
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Inclusion Criteria:
Patients with histologically proven prostate adenocarcinoma.
Prior radical prostatectomy or radiation therapy with curative intent.
Recurrence of disease defined as:
Patients with at least one extraprostatic site of disease suspected based on prior imaging or diagnosed by biopsy.
Age greater than or equal to 18 years.
Able to understand and provide signed written informed consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06520 | United States | ||
| Edward Hines, Jr. VA Hospital |
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The study was conducted in 9 sites across USA, Recruitment was initiated on 30 November, 2022 and was closed on 17 May 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic Imaging With 64Cu-PSMA-I&T | 64Cu-PSMA I&T: Radiolabeled Receptor-Targeted Diagnostic Product |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 16, 2022 |
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| Hines |
| Illinois |
| 60141 |
| United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Saint Louis University | St Louis | Missouri | 63104 | United States |
| John J. Cochran Veterans Hospital | St Louis | Missouri | 63106 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | United States |
| XCancer Omaha/Urology Cancer Center | Omaha | Nebraska | 68130 | United States |
| MD Anderson | Houston | Texas | 77030 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic Imaging With 64Cu-PSMA-I&T | 64Cu-PSMA I&T: Radiolabeled Receptor-Targeted Diagnostic Product |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Height | centimeters (cm) | Mean | Standard Deviation | CM |
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| Weight | kilograms (kg) | Mean | Standard Deviation | KG |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | percentage of Regions | 4 Hours |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of Patients | 4 Hours |
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| 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. | All 26 patients were analyzed for Adverse Events through the monitoring of clinical and laboratory safety parameters. | Posted | Count of Participants | Participants | 24 Hours |
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| 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. | 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. | Posted | Count of Participants | Participants | 4 Hours |
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24 Hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic Imaging With 64Cu-PSMA-I&T | 64Cu-PSMA I&T: Radiolabeled Receptor-Targeted Diagnostic Product | 0 | 26 | 0 | 26 | 0 | 26 |
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The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period no less than 90 days but less than or equal to 120 days from the time submitted to the sponsor for review. Also, the PI can utilize results of clinical tests and site and patient outcome information only for its own internal non-commercial teaching, research, patient care, and treatment and publication purposes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Darcy Denner | Curium | 314-506-3511 | Solar@curiumpharma.com |
| May 29, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Reader 2 (4-Hour Image) |
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| Reader 3 (1-Hour Image) |
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| Reader 3 (4-Hour Image) |
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