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RECRUITING
NCT07568613
NA

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

Sponsor: German Oncology Center, Cyprus

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-08-18

Completion Date

2027-07-31

Last Updated

2026-05-06

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

MRI

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

DIAGNOSTIC_TEST

18F-PSMA1007 PET-CT

PET scan according to standard protocol

DIAGNOSTIC_TEST

MR-guided TRUS Prostate biopsy

Biopsy according to standard protocol

Locations (1)

German Oncology Center

Limassol, Cyprus