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

NCT ID: NCT07258056

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-03

Study Completion Date

2038-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PSMA-guided and systematic biopsies

Both PSMA-guided and systematic biopsies are performed

Group Type EXPERIMENTAL

PSMA-guided and systematic biopsies

Intervention Type DIAGNOSTIC_TEST

Both PSMA-guided and systematic biopsies are performed

Interventions

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PSMA-guided and systematic biopsies

Both PSMA-guided and systematic biopsies are performed

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mads Ryo Jochumsen

OTHER

Sponsor Role lead

Responsible Party

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Mads Ryo Jochumsen

MD, Ph.D.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Aarhus University Hospital

Aarhus N, Aarhus, Denmark

Site Status RECRUITING

Goedstrup Hospital

Herning, Herning, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Mads R Jochumsen, MD, Ph.D.

Role: CONTACT

+45 + 78456270

Facility Contacts

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Mads R Jochumsen, MD, Ph.D.

Role: primary

Role: backup

Kasper D Berg, MD, Ph.D.

Role: primary

45 + 78439450

Other Identifiers

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1-10-72-109-25

Identifier Type: -

Identifier Source: org_study_id

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