RecruitingNot ApplicableNCT07568613

Comparing PSMA PET/CT and MRI-RSI for Finding and Outlining Tumors Inside the Prostate in Men With Newly Diagnosed Prostate Cancer

Prospective Comparison of PSMA PET/CT and MRI-RSI (Restriction Spectrum Imaging) for Intraprostatic Tumor Detection and Delineation in Primary Prostate Cancer Patients


Sponsor

German Oncology Center, Cyprus

Enrollment

50 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The detection and delineation of the intraprostatic tumor burden plays a crucial role in the personalized treatment of primary prostate cancer. The current gold standard multiparametric magnetic resonance imaging (mpMRI) is used to guide targeted prostate biopsies for initial diagnostic work up and for definitive focal dose-escalated radiotherapy in intermediate and high-risk prostate cancer patients. However, mpMRI might underestimate the tumor volume and manual gross tumor volume delineation based on mpMRI underlies significant interobserver variability. Thus, novel imaging modalities are warranted to increase the detection rate and/or decrease the interobserver variability during tumor delineation. This study will prospectively compare two promising advanced medical imaging methods: MRI-RSI and PSMA PET with the current gold-standard mpMRI for tumor detection and delineation in primary prostate cancer patients.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying 18F-PSMA1007 PET-CT, MR-guided TRUS Prostate biopsy, and others for people with prostate cancer. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTMRI

MRI-RSI imaging of the prostate (non-invasive)

DIAGNOSTIC_TEST18F-PSMA1007 PET-CT

PET scan according to standard protocol

DIAGNOSTIC_TESTMR-guided TRUS Prostate biopsy

Biopsy according to standard protocol


Locations(1)

German Oncology Center

Limassol, Cyprus

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NCT07568613


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