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Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Guided Biopsy in Men With Elevated PSA

NCT03187990 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-09-02

No results posted yet for this study

Summary

In 22% of patients with elevated Prostate-specific antigen (PSA) MRI guided biopsy will not detect significant prostate cancer (PCA) (defined as either: Gleason score (GS) ≥ 3+4 or tertiary pattern 5, or final stage ≥ pT3a and/or pN1). Therefore this study evaluates the ability of \[68Ga\]PSMA PET/MRI to detect and localize significant primary PCA to accurately direct prostate needle biopsy using the Gleason score from the histology of the core biopsies as standard of truth.

Conditions

Interventions

DRUG

[68Ga]PSMA-11

PET/MRI with \[68Ga\]PSMA will be compared to mpMRI for biopsy guidance.

DRUG

[18F]PSMA-1007

18F-PSMA-1007 PET/CT for biopsy guidance and intraoperative target verification.

Sponsors & Collaborators

  • Irene Burger

    lead OTHER

Principal Investigators

  • Irene A Burger, MD · UniversitaetsSpital Zuerich

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-03
Primary Completion
2021-08-03
Completion
2021-08-03

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT03187990 on ClinicalTrials.gov