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Recruiting NCT07258056

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

No phase Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PSMA-guided and systematic biopsies.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Diagnostic test PSMA-guided and systematic biopsies
    Both PSMA-guided and systematic biopsies are performed

Primary outcome measures

  • 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]
Secondary outcome measures (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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Denmark · 2 centers
  • Aarhus University Hospital — Aarhus N
  • Goedstrup Hospital — Herning

Identifiers

NCT: NCT07258056 · 1-10-72-109-25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗