68Ga-RM2 PET / MRI Scan and 68Ga-RM2 PET / MRI Scan in Imaging Patients with Suspected Prostate Cancer

Status: Active

Description

This phase II trial studies how well 68Ga-PSMA-11 positron emission tomography (PET) / magnetic resonance imaging (MRI) scan and 68Ga-RM2 PET / MRI scan work in imaging patients with suspected prostate cancer. Diagnostic procedures, such as 68Ga-PSMA-11 PET / MRI scan and 68Ga-RM2 PET / MRI scan, may help find and diagnose prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Suspected prostate cancer
  • Planned prostate biopsy
  • Able to provide written consent
  • Karnofsky performance status of 50 (or 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
  • Metallic implants (contraindicated for MRI)

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. To evaluate Gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) PET/MRI and Gallium Ga 68-labeled GRPR antagonist BAY86-7548 (68Ga-RM2) PET/MRI for biopsy guidance in patients with suspected prostate cancer.

EXPLORATORY OBJECTIVES:

I. Correlation of 68Ga PSMA 11 uptake and Gleason score at biopsy.

II. Correlation of 68Ga RM2 and Gleason score at biopsy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive 68Ga-RM2 intravenously (IV) at baseline and then undergo PET/MRI scan over 30-60 minutes at 45 minutes post 68Ga-RM2 administration. Within 2 weeks of 68Ga-RM2 PET/MRI scan, patients receive 68Ga-PSMA11 IV and then undergo PET/MRI scan over 30-60 minutes at 45-60 minutes post 68Ga- PSMA11 administration.

ARM II: Patients receive 68Ga-PSMA11 IV at baseline and then undergo PET/MRI scan over 30-60 minutes at 45-60 minutes post 68Ga- PSMA11 administration. Within 2 weeks of 68Ga-PSMA11 PET/MRI scan, patients receive 68Ga-RM2 IV and then undergo PET/MRI scan over 30-60 minutes at 45 minutes post 68Ga-RM2 administration.

After completion of study scan, patients are followed up at 24 to 72 hours and then up to 12 months.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Diagnostic

Lead Organization

Lead Organization
Stanford Cancer Institute Palo Alto

Principal Investigator
Andrei Iagaru

Trial IDs

Primary ID PROS0091
Secondary IDs NCI-2019-00236, IRB-48151
Clinicaltrials.gov ID NCT03809078