Gallium Ga 68-labeled PSMA-11 PET / CT in Detecting Prostate Cancer Recurrence in Patients with Elevated PSA after Initial Treatment

Status: Temporarily Closed to Accrual


This phase II / III trial studies how well gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 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-11 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-11 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.

Eligibility Criteria

Inclusion Criteria

  • Histopathological-proven prostate adenocarcinoma
  • Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy) * Post radical prostatectomy (RP) – AUA recommendation ** PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical prostatectomy ** 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 the study 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

Locations & Contacts


Palo Alto
Stanford Cancer Institute Palo Alto
Status: Temporarily closed to accrual
Contact: Andrei Iagaru
Phone: 650-725-4711

Trial Objectives and Outline


I. To evaluate gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated PSA.


Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV). After 50-100 minutes, patients undergo whole body (skull base to mid-thighs) PET/CT scan.

After completion of study procedure, patients are followed up at 24-48 hours and 3-12 months.

Trial Phase & Type

Trial Phase

Phase II/III

Trial Type


Lead Organization

Lead Organization
Stanford Cancer Institute Palo Alto

Principal Investigator
Andrei Iagaru

Trial IDs

Primary ID PROS0076
Secondary IDs NCI-2016-00094, 35932 ID NCT02673151