Trial Search Results

68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment

This trial studies how well gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx)-HBED-CC (68Ga-PSMA) positron emission tomography (PET)/computed tomography (CT) works in detecting prostate cancer that may have come back in patients with elevated prostate-specific antigen (PSA) after initial treatment. A rise in blood level of PSA, a protein made by the prostate, after treatment with surgery or radiation in patients without symptoms indicates that the cancer may have come back (recurrence). PSA however cannot determine whether the disease is located only in the prostate or other places in the body. 68Ga-PSMA is a radioactive tracer that targets and specifically binds to tumor cells expressing PSA making them lighting up. PET and CT make computerizing pictures of areas inside the body where the radioactive substance is lighting up. 68Ga-PSMA PET/CT may be able to see smaller tumors than standard imaging and may help determine whether prostate cancer has come back and where it is in the body.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Andrei Iagaru

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):


  • Procedure: Computed Tomography
  • Drug: Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • Other: Laboratory Biomarker Analysis
  • Procedure: Positron Emission Tomography


Phase 2


Inclusion Criteria:

   - Histopathological proven prostate adenocarcinoma

   - Rising PSA after definitive therapy with prostatectomy or radiation therapy (external
   beam or brachytherapy)

      - Post radical prostatectomy (RP) - American Urology Association (AUA)

         - PSA greater than 0.2 ng/mL measured 6-13 weeks after RP

         - Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA
         measurements greater than 0.2 ng/mL)

      - Post-radiation therapy -American Society for Radiation Oncology (ASTRO)-Phoenix
      consensus definition

         - A rise of PSA measurement of 2 or more ng/mL over the nadir

   - Able to provide written consent

   - Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group
   [ECOG]/World Health Organization [WHO] equivalent)

Exclusion Criteria:

   - Investigational therapy for prostate cancer.

   - Unable to lie flat, still or tolerate a PET scan.

   - Prior history of any other malignancy within the last 2 years, other than skin basal
   cell or cutaneous superficial squamous cell carcinoma that has not metastasized and
   superficial bladder cancer.

   - Contraindication to furosemide administration including prior allergy or adverse
   reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed
   if Furosemide is omitted as part of the PET imaging protocol if a second-generation
   scatter correction is available for the used PET device).

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
David Marcellus
Not Recruiting