Overview

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