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

NCT03113617 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-12-12

Study results available
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Summary

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.

Conditions

  • Stage II Prostate Adenocarcinoma
  • Stage III Prostate Adenocarcinoma
  • Stage IV Prostate Adenocarcinoma

Interventions

PROCEDURE

Computed Tomography

Undergo PET/CT

DRUG

Gallium Ga 68-labeled GRPR Antagonist BAY86-7548

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Sponsors & Collaborators

  • Andrei Iagaru

    lead OTHER

Principal Investigators

  • Andrei Iagaru · Stanford Cancer Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2021-12-19
Completion
2021-12-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03113617 on ClinicalTrials.gov