68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer

Not Recruiting

Trial ID: NCT03113617

Purpose

This phase II trial studies how well gallium Ga 68-labeled gastrin-releasing peptide receptor (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/computed tomography (CT) works in detecting regional nodal and distant metastases in patients with intermediate or high-risk prostate cancer. 68Ga-RM2 PET/CT scan may be able to see smaller tumors than the standard of care CT or magnetic resonance imaging scan.

Official Title

68Ga-RM2 PET/CT for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer

Stanford Investigator(s)

Andrei Iagaru
Andrei Iagaru

Professor of Radiology (Nuclear Medicine)

Eligibility

Inclusion Criteria:

* Biopsy proven prostate adenocarcinoma
* Planned prostatectomy with lymph node dissection
* Intermediate to high-risk disease (as determined by elevated PSA \[PSA \> 10\], 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) performed within 30 days prior to the 68Ga-RM2 PET

Exclusion Criteria:

* Inability to lie still for the entire imaging time (approximately 30 minutes)
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance

Intervention(s):

procedure: Computed Tomography

drug: Gallium Ga 68-labeled GRPR Antagonist BAY86-7548

other: Laboratory Biomarker Analysis

procedure: Positron Emission Tomography

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
David Marcellus
650-723-4547

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