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

Condition: Biochemically Recurrent Prostate Carcinoma, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04777071

Sponsor: University of Washington

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

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

View trial on ClinicalTrials.gov