GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies (GUIDE PSMA PET)

November 26, 2025 updated by: Mads Ryo Jochumsen

GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies (GUIDE PSMA PET/MRI)

The goal of this clinical study is to test the performance of PSMA PET/MRI-guided biopsies against systematic biopsies in men with negative MRI scan (PI-RADS 1-2) of the prostate with continuous suspicion of clinically significant prostate cancer (csPCa) due to PSAd > 0.20. The main questions it aims to answer are:

Can biopsies safely be avoided at PRIMARY score 1-2 without missing csPCa? Does targeted PSMA PET/MRI-guided biopsies have a higher detection rate of csPCa compared to systematic biopsies?

Participants will undergo both transperineal MRI/ultrasound fusion target biopsies from PRIMARY score 3-5 lesions on PSMA PET and systematic biopsies irrespective of the PRIMARY-lesion.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mads R Jochumsen, MD, Ph.D.
  • Phone Number: +45 + 78456270
  • Email: madsjoch@rm.dk

Study Locations

  • Denmark
    • Aarhus
      • Aarhus N, Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital
        • Contact:
          • Mads R Jochumsen, MD, Ph.D.
          • Phone Number: 78456270
          • Email: madsjoch@rm.dk
        • Contact:
        • Principal Investigator:
          • Mads R. Jochumsen, MD, Ph.D.
        • Sub-Investigator:
          • Morten H Andersen, MD
    • Herning
      • Herning, Herning, Denmark, 7400
        • Recruiting
        • Goedstrup Hospital
        • Contact:
          • Kasper D Berg, MD, Ph.D.
          • Phone Number: 45 + 78439450
          • Email: KASPBG@rm.dk
        • Principal Investigator:
          • Kasper D Berg, MD, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • PSAdensity > 0.20
  • Negative MRI (PI-RADS 1-2) or negative biopsy from MRI-target
  • MRI within 6 months
  • Read and understand danish
  • Expected remaining lifetime > 10 years

Exclusion Criteria:

  • Known prostate cancer
  • MRI contraindications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PSMA-guided and systematic biopsies
Both PSMA-guided and systematic biopsies are performed
Diagnostic test: PSMA-guided and systematic biopsies
Both PSMA-guided and systematic biopsies are performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate of clinically significant prostate cancer (csPCa) for PSMA guided biopsies vs systematic biopsies
Time Frame: From enrollment to pathology report is ready, assessed up to 2 years

CsPCa is defined as "International Society of Urological Pathology" (ISUP) grade ≥ 2.

The ISUP grade scale ranges from 1 to 5, where grade 1 is low-risk / indolent / non-significant prostate cancer and grade 5 is the most aggressive prostate cancer form with worse outcome.
From enrollment to pathology report is ready, assessed up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High negative predictive value for having csPCa in case of PRIMARY 1-2 (and PI-RADS 1-2)
Time Frame: From enrollment to pathology report, assessed up to 2 years
A high negative predictive value for having csPCa in case of PRIMARY 1-2 (and PI-RADS 1-2) means that biopsies can safely be avoided in patients with PRIMARY 1-2 lesions only.
From enrollment to pathology report, assessed up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mads Ryo Jochumsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2038

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-109-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Relevant data from the study will be made avilable and published, but the investigators do not have permission to share individual participant data with external researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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