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68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery

NCT02678351 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2022-03-04

Study results available
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Summary

This phase 2-3 trial studies the utility of 68-gallium (68Ga)-prostate-specific membrane antigen 11 (PSMA-11) positron emission tomography/magnetic resonance imaging (PET/MRI) to find tumors in patients with prostate cancer who are undergoing resection surgery for prostate cancer that is prognostically expected 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 reveal out how far the disease has spread. Radioactive drugs, such as 68Ga-PSMA-11, may bind 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.

Conditions

  • Stage II Prostate Adenocarcinoma
  • Stage III Prostate Adenocarcinoma

Interventions

DRUG

68Ga-PSMA-11

Undergo 68Ga-PSMA-11 PET/MRI

PROCEDURE

Magnetic resonance imaging (MRI)

Undergo 68Ga-PSMA-11 PET/MRI

PROCEDURE

Positron Emission Tomography (PET)

Undergo 68Ga-PSMA-11 PET/MRI

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Andrei Iagaru

    lead OTHER

Principal Investigators

  • Andrei Iagaru · Stanford University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-18
Primary Completion
2020-12-13
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT02678351 on ClinicalTrials.gov