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Radiopharmaceutical PET imaging tracer injected intravenously for the detection of PSMA expression.

Copper Cu 64 PSMA I&T

Darcy Denner, PhD

This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with recurrent prostate cancer after radical prostatectomy or radiation therapy.

The study will include approximately 200 patients with suspected biochemically recurrant prostate cancer. Each patient will be administered an 8 mCi (± 10 percent) intravenous dose of copper Cu 64 PSMA I\&T injection. PET/CT imaging will be acquired for all patients at 1-4 hours ± 15 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. Analysis of the reads will be used for determination of the patient-level correct detection rate and region-level correct localization rate of copper Cu 64 PSMA I\&T PET/CT by comparison to the Reference Standard.

Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer

A Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Men With Biochemical Recurrence of Prostate Cancer

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 between 60 minutes to 240 minutes 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.

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 between 60 and 240 minutes 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.

Comparison of patient level CDR and region level CLR of copper Cu 64 PSMA I\&T PET/CT stratified by Prostate-Specific Antigen level.

Comparison of patient-level CDR and region level CLR of copper Cu 64 PSMA I\&T PET/CT separated into subgroups of patients with histopathology available and unavailable.

Reader kappa statistics of copper Cu 64 PSMA I\&T PET/CT scan interpretation by the blinded independent readers.

Treatment-emergent adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Curium US LLC

Radiopharmaceutical PET imaging tracer injected intravenously for staging of prostate cancer.

This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.

The study will include approximately 323 patients with newly diagnosed unfavorable intermediate high-risk, high-risk or veru high-risk prostate cancer electing to undergo radical prostatectomy with pelvic lymph node dissection. Each patient will be administered an 8 mCi (± 10 percent) intravenous dose of copper Cu 64 PSMA I\&T injection. PET/CT imaging will be acquired for all patients at 1-4 hours ± 15 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 lesions considered positive for Prostate Cancer (PC) in pelvic lymph nodes. Positive lesions in the prostate, extra pelvic lymph nodes, bones and soft tissue/viscera will also be recorded. Analysis of the reads will be used for determination of sensitivity and specificity of copper Cu 64 PSMA I\&T PET/CT by comparison to the reference standard of histopathology after matching by hemipelvis with at least one true positive lesion defining a true positive patient. Detection of PC outside the pelvis on the copper Cu 64 PSMA I\&T PET/CT will be assessed using reference standard of histopathology and if not available conventional imaging. Baseline conventional imaging will be reviewed for PC disease or no disease by independent radiology readers.

Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer

Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging Men With Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy With Pelvic Lymph Node Dissection

Correlation of sensitivity, specificity, detection rate, and Positive Predictive Value (PPV) to baseline PSA and unfavorable intermediate-risk, high-risk or very high-risk at the time of prostatectomy.

Proportion of patients with M1 lesions on copper Cu 64 PSMA I\&T PET/CT subsequently confirmed to be TP by biopsy, surgery and confirmatory imaging.

Percentage of patients in whom the copper Cu 64 PSMA I\&T PET/CT changed the intended patient management (major and other changes).

Patient level positivity rates of copper Cu 64 PSMA I\&T split by pelvic lymph nodes and extra pelvic lesions.

Determine the diagnostic performance of copper Cu 64 PSMA I\&T PET/CT for the detection of presence or absence of pelvic lymph node metastasis in pre-prostatectomy patients by risk group (unfavorable intermediate, high, or very high risk).

Determine the presence of metastatic pelvic lymph nodes relative to histopathology reference standard. At least one positive pelvic lymph node on the PET scan and one positive lymph node as determined by histopathology on the same side of the pelvis (left or right) will be counted a true positive at the patient level.

Determine the absence of metastatic pelvic lymph nodes relative to histopathology reference standard. Negative pelvic lymph node on the PET scan and negative pelvic lymph nodes as determined by histopathology on the same side of the pelvis (Left or Right) will be counted a true negative at the patient level.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer	NCT06235099	Prostate Cancer Prostate Adenoc... Biochemical Rec...	Copper Cu 64 PS...	18 Years -	Curium US LLC
Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer	NCT06235151	Prostate Cancer Prostate Adenoc...	Copper Cu 64 PS...	18 Years -	Curium US LLC

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