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

NCT07258056 | Recruiting

• 1 other identifier: 1-10-72-109-25
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

PSMA; PET/MRI; Prostate cancer; biopsy guidance

Outcome Measures

Primary Outcomes (1)

• Detection rate of clinically significant prostate cancer (csPCa) for PSMA guided biopsies vs systematic biopsies

  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 Outcomes (1)

• High negative predictive value for having csPCa in case of PRIMARY 1-2 (and PI-RADS 1-2)

  From enrollment to pathology report, assessed up to 2 years

Study Arms (1)

PSMA-guided and systematic biopsies

EXPERIMENTAL

Both PSMA-guided and systematic biopsies are performed

Diagnostic Test: PSMA-guided and systematic biopsies

Interventions

PSMA-guided and systematic biopsies DIAGNOSTIC_TEST

Both PSMA-guided and systematic biopsies are performed

PSMA-guided and systematic biopsies

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known prostate cancer
• MRI contraindications

Sponsors & Collaborators

• Mads Ryo Jochumsen: lead

Study Sites (2)

Aarhus University Hospital

Aarhus N, Aarhus, 8200, Denmark

RECRUITING

Goedstrup Hospital

Herning, Herning, 7400, Denmark

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Mads R Jochumsen, MD, Ph.D.

CONTACT

+45 + 78456270; madsjoch@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Ph.D.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 2, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2038
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)