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

Inclusion Criteria7

  • Newly diagnosed and histologically confirmed primary prostate cancer
  • NCCNv4.2024 risk groups: unfavorable intermediate risk, high-risk and very high-risk
  • Males, age ≥ 18 years
  • ECOG performance status 0-2
  • Estimated life expectancy ≥ 5 years
  • PSMA-PET/CT-hybrid imaging performed <3 months
  • MRI-targeted biopsy on PIRADs v2.1 lesion ≥3 performed <6 months

Exclusion Criteria7

  • Contraindications for MRI imaging
  • No visible tumor on PSMA PET and mpMRI (defined by PIRADs v2.1 ≤2 lesion)
  • TUR-P of the prostate <1 year ago
  • Initial PSA >100 ng/ml
  • History of cancer (exception: localized skin tumours, tumours treated ≥5 years previously with curative intent and no evidence of recurrent disease)
  • Previous radiation therapy to the pelvis
  • ADT or ADT + other systemic therapy before inclusion

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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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