68Ga-PSMA PET / MRI in Finding Tumors in Patients with Intermediate or High-Risk Prostate Cancer Undergoing Surgery

Status: Active

Description

This phase II / III trial studies gallium 68 Ga (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography / magnetic resonance imaging (PET / MRI) in finding tumors in patients with prostate cancer undergoing surgery that tend to spread quickly (intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures, such as PET / MRI, may help find and diagnose prostate cancer and find out how far the disease has spread. Radioactive drugs, such as gallium Ga 68-PSMA, binds to tumor cells that have specific receptors, and may allow doctors to see smaller tumors than the standard of care contrast-enhanced computed tomography (CT) or MRI scan.

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], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors)
  • No evidence of metastatic disease on conventional imaging, including a negative bone scan for skeletal metastasis and/or negative cross section imaging (MR or CT)
  • Able to provide written consent
  • Karnofsky performance status of >= 50 (Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)

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
  • Androgen deprivation therapy prior to PET imaging
  • Metallic implants

Locations & Contacts

California

Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Contact: Andrei Iagaru
Phone: 650-725-4711
Email: aiagaru@stanford.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Evaluate 68Ga-PSMA (gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx)-HBED-CC) PET/MRI for detection of regional nodal and distant metastases in patients with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx)-HBED-CC intravenously (IV). Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.

After completion of study, patients are followed up at 24-48 hours.

Trial Phase & Type

Trial Phase

Phase II/III

Trial Type

Diagnostic

Lead Organization

Lead Organization
Stanford Cancer Institute Palo Alto

Principal Investigator
Andrei Iagaru

Trial IDs

Primary ID PROS0075
Secondary IDs NCI-2016-00092, 35931
Clinicaltrials.gov ID NCT02678351