68Ga PSMA-HBED-CC PET / CT in Imaging Patients with Metastatic Prostate Cancer

Status: Active

Description

This pilot clinical trial studies how well 68Ga PSMA-HBED-CC positron emission tomography / computed tomography (PET / CT) works in imaging patients with prostate cancer that has spread to other parts of the body. Diagnostic procedures, such as 68Ga PSMA-HBED-CC PET / CT, may help find and diagnose metastatic prostate cancer and find out how far the disease has spread.

Eligibility Criteria

Inclusion Criteria

  • Histological diagnosis of adenocarcinoma of the prostate OR has a clinical diagnosis of prostate cancer and on active therapy or has received treatment for prostate cancer
  • Multifocal metastatic disease in either castrate sensitive or castrate resistant patients
  • May or may not be on hormonal therapy, chemotherapy, or radium therapy; if on hormonal therapy or chemotherapy, must be on it for at least 3 months
  • No plans to undergo prostate cancer (PCa) therapy (with hormone therapy, chemotherapy, radium therapy, or external radiation) between the two study exams
  • At least 2 metastatic soft tissue or osseous lesions identified on conventional imaging (CT, magnetic resonance imaging [MRI] or bone scan)
  • Karnofsky performance status of 50 or greater (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)
  • Ability to understand and willingness to sign a consent document

Exclusion Criteria

  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring hospitalization, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Physical limitation that would limit compliance with the study requirements
  • Current enrollment in a therapeutic clinical trial

Locations & Contacts

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Janet Pollard
Phone: 319-356-3380
Email: janet-pollard@uiowa.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Determine the biodistribution, quantitative time course, and the range of uptake in normal organs using gallium Ga 68-labeled PSMA ligand Glu-urea-Lys[Ahx] ([68Ga]Glu-urea-Lys(Ahx)-HBED-CC) (68Ga prostate specific membrane antigen [PSMA]-HBED-CC) positron emission tomography (PET) in patients with metastatic castrate resistant prostate cancer.

II. Analyze reproducibility of 68Ga PSMA-HBED-CC PET uptake in target tumors and normal tissues.

SECONDARY OBJECTIVES:

I. To corroborate radiopharmaceutical radiation dosimetry estimates found in the literature.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) intravenously (IV) on day 0. Beginning 60 minutes after injection, patients undergo PET/CT for about 30-40 minutes on day 0. Within 1-15 days, patients undergo a second gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) PET/CT.

After completion of study, patients are followed at 24 hours and and then within 3 days.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
University of Iowa / Holden Comprehensive Cancer Center

Principal Investigator
Janet Pollard

Trial IDs

Primary ID 201605762
Secondary IDs NCI-2016-01204
Clinicaltrials.gov ID NCT02952469