An Investigational Scan (68Ga-PSMA-11 PET/CT) for the Imaging of Prostate Cancer

• Status: Recruiting
• Trial end date: 2027-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

This trial studies how well 68Ga-PSMA-11 PET/CT scan works in imaging patients with prostate cancer. Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT may find and diagnose prostate cancer and improve monitoring of treatment response.

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

Details

• Lead Sponsor: University of Washington
• Treatments: Edetic Acid; Gallium 68 PSMA-11

Criteria

Inclusion Criteria:

• Pathologically proven prostate adenocarcinoma

• For the initial staging arm, high risk characteristics, including any of the following:

• Grade group 4-5 and/or

• PSA > 20 ng/mL

• For patients with biochemical recurrence:

• Rising PSA after definitive therapy with prostatectomy or targeted local therapy (including but not limited to external beam radiation therapy, brachytherapy, high-frequency ultrasound, and cryotherapy)

• If post-radical prostatectomy, PSA > 0.2 ng/mL measured > 6 weeks post-operatively and confirmatory persistent PSA greater than 0.2 ng/mL (American Urological Association (AUA) definition for biochemical recurrence

• If post-radiation therapy, PSA that is equal to, or greater than, a 2 mg/mL rise above PSA nadir (American Society of Radiation Oncology (ASTRO) definition for biochemical recurrence)

• For patients undergoing systemic therapy:

• Diagnosis of metastatic castration-resistant prostate cancer

• At least one or more measurable (> 1 cm diameter in short axis) or evaluable lesions by conventional imaging

• Any patient with an equivocal lesion by conventional imaging, regardless of where they are in the course of evaluation or treatment

• No other malignancy within the past 2 years (with the exception of skin basal cell or cutaneous superficial squamous cell carcinoma, superficial bladder cancer, carcinoma in situ in any location, or Rai Stage 0 chronic lymphocytic leukemia, which are allowed)

• Karnofsky performance status (KPS) >= 50, Eastern Cooperative Oncology Group/World Health Organization (ECOG/WHO) grades 0, 1, or 2

• Ability to understand and willingness to provide informed consent

Exclusion Criteria:

• Allergy to furosemide

• History of Stevens-Johnson syndrome

• History or diagnosis of Paget's disease

• Allergy to sulfa or sulfa-containing medications

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements