68Ga-PSMA-11 PET in Patients With Prostate Cancer

• Status: Not yet recruiting
• Trial end date: 2026-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver

Criteria

Inclusion Criteria:

• Histopathologically proven prostate adenocarcinoma

• Age ≥ 18 years

• Patients already diagnosed with prostate cancer: Primary Staging: intermediate and high-risk patients per NCCN guidelines

• Biochemical Recurrence: Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy):

a. Post radical prostatectomy (RP) - AUA recommendation i. PSA greater than or equal to 0.2 ng/mL measured more than 6-13 weeks after RP and confirmed by a second determination of a PSA level of >0.2 ng/mL b. Post-radiation therapy - ASTRO-Phoenix consensus definition i. Nadir + greater than or equal to 2 ng/mL rise in PSA

• Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

• Unable to lie flat, still or tolerate a PET/CT scan, or any other condition that would preclude PET/CT imaging.

• Patients with any medical condition or circumstance that the investigator believes may compromise the data collection or lead to a failure to fulfil the study requirements.

• Patients with known hypersensitivity to the active substance or to any of the excipients of the investigational product.