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NCT Number: NCT07258056

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Aarhus N, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PSMA-guided and systematic biopsies

Diagnostic Test

Both PSMA-guided and systematic biopsies are performed

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mads R Jochumsen, MD, Ph.D.

CONTACT

[email protected]

+45 + 78456270

Sponsors and collaborators

Lead sponsor

Mads Ryo Jochumsen

Other

Registry information

Official study title

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

Acronym: GUIDE PSMA PET

Important dates

Study start
2025
Primary completion
2028
Study completion
2038
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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