Cu-64-PSMA-I&T Positron Emission Tomography (PET) Imaging of Metastatic PSMA Positive Lesions in Men With Prostate Cancer

Status: complete

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.

Inclusion Criteria

Patients with histologically proven prostate adenocarcinoma.
Prior radical prostatectomy or radiation therapy with curative intent.
Recurrence of disease defined as:
Prior Radical Prostatectomy: PSA > 0.2 ng/mL, or
Prior Radiation Therapy: 2 ng/mL rise in PSA over post-treatment nadir
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

Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway, unless subject has a rising PSA level.
Body weight greater than 350 lb (158 kg).
Investigational therapy within the past 30 days.
Creatinine clearance (ClCr) less than 30 mL/min.
Participants who are capable of fathering a child and who are unwilling to take precautions to prevent pregnancy.

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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Cu-64-PSMA-I&T Positron Emission Tomography (PET) Imaging of Metastatic PSMA Positive Lesions in Men With Prostate Cancer

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