68Ga-PSMA-11 PET / CT in Imaging Patients with Intermediate or High Risk Prostate Cancer before Surgery

Status: Active

Description

This clinical trial studies how well 68Ga-PSMA-11 positron emission tomography (PET) / computed tomography (CT) works in imaging patients with intermediate or high risk prostate cancer before surgery. Diagnostic procedures, such as PET / CT scans, may help find and diagnose prostate cancer and find out how far the disease has spread.

Eligibility Criteria

Inclusion Criteria

  • Biopsy proven prostate adenocarcinoma
  • Planned prostatectomy with lymph node dissection
  • Intermediate to high-risk disease (as determined by elevated prostate specific antigen [PSA] [PSA > 10], tumor [T]-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors)
  • Able to provide written consent
  • Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)
  • Diagnostic CT or magnetic resonance imaging (MRI) as part of the PET study or performed within one month of PSMA PET

Exclusion Criteria

  • Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
  • Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (high-intensity focused ultrasound ablation [HiFu])

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Johannes Czernin
Phone: 310-206-3226

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To evaluate gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx)-HBED-CC (68Ga-PSMA-11) PET/CT for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis.

OUTLINE:

Patients receive 68Ga-PSMA-11 intravenously (IV) and undergo a single PET/CT scan over 45-60 minutes at week 1.

After completion of study, patients are followed up at 1-3 days.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
UCLA / Jonsson Comprehensive Cancer Center

Principal Investigator
Johannes Czernin

Trial IDs

Primary ID 16-001684
Secondary IDs NCI-2016-01768
Clinicaltrials.gov ID NCT03368547