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

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

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04777071

Sponsor: University of Washington

Phase: Phase 2


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

Inclusion Criteria:

  • Pathologically proven prostate adenocarcinoma
  • For the initial staging arm (initial staging cohort), high risk characteristics, including any of the following:
  • Grade group 4-5 and/or
  • PSA > 20 ng/mL
  • For patients with biochemical recurrence (biochemical recurrence cohort):
  • 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 (treatment monitoring cohort):
  • Diagnosis of metastatic castration-resistant prostate cancer
  • At least one or more measurable ( > 1 cm diameter in short axis) or evaluable lesions by any modality obtained within the past 60 days
  • Planned for treatment with standard of care androgen receptor pathway inhibitor or chemotherapy
  • Any patient with an equivocal lesion by conventional imaging, regardless of where they are in the course of evaluation or treatment (equivocal lesion cohort)
  • 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)
  • Eastern Cooperative Oncology Group/World Health Organization (ECOG/WHO) performance status grades 0, 1, or 2
  • Ability to understand and willingness to provide informed consent

Exclusion Criteria:

  • 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