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

• Status: Not yet recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Curium US LLC

Criteria

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.