Gallium Ga 68-labeled PSMA-11 PET in Detecting Prostate Cancer Metastasis

Status: Active

Description

This phase III trial studies how well gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET) works in detecting prostate cancer that has spread to other places in the body. PSMA is a protein found on most prostate cancers. Gallium Ga 68-labeled PSMA-11 is an imaging agent that binds to prostate cancer cells and can be imaged using PET scan. A PET scan uses a special camera to detect energy given off from radioactive material to make detailed pictures of areas where the Ga-68 accumulates in the body. The PET scan if often combined with a magnetic resonance imaging (MRI) or computed tomography (CT) scan may help to more accurately map the location of where in the body the radioactive material has collected. Gallium Ga 68-labeled PSMA-11 may help to detect the presence of prostate cancer that has spread to other places in the body (metastasis).

Eligibility Criteria

Inclusion Criteria

  • Histopathologically proven prostate adenocarcinoma
  • Concern for metastatic disease in the following settings: * Initial staging with intermediate to high risk prostate cancer * Biochemical recurrence after initial therapy
  • Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)
  • Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria

  • Unable to lie flat, still or tolerate a PET scan

Locations & Contacts

California

San Francisco
UCSF Medical Center-Mount Zion
Status: Active
Contact: Thomas A. Hope
Phone: 415-353-9437
Email: thomas.hope@ucsf.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Sensitivity on a per-patient and per-region-basis of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 1-2 minutes. Beginning 50-100 minutes after injection, patients undergo PET/CT scan over 30-60 minutes or PET/MRI scan over 50-60 minutes.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Diagnostic

Lead Organization

Lead Organization
UCSF Medical Center-Mount Zion

Principal Investigator
Thomas A. Hope

Trial IDs

Primary ID 185513
Secondary IDs NCI-2019-01394, 15-17570
Clinicaltrials.gov ID NCT03803475