Comparing PSMA PET/CT and MRI-RSI for Finding and Outlining Tumors Inside the Prostate in Men With Newly Diagnosed 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: MRI, 18F-PSMA1007 PET-CT, MR-guided TRUS Prostate biopsy.
- 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
- Cyprus
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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
Primary outcome measures
- Sensitivity [Time frame: 24 months]
- Absolute GTV volumes [Time frame: 24 months]
- Specificity [Time frame: 24 months]
- ROC-AUC [Time frame: 24 months]
Secondary outcome measures (3)
- Dice Sorensen Coefficient (DSC) [Time frame: 24 months]
- Dose volume histogram parameters in volume (ml) in relation to Gray [Time frame: 24 months]
- Correlation coefficient (Spearman or Pearson) [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
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
Cyprus · 1 center
- German Oncology Center — Limassol
Identifiers
NCT: NCT07568613 · ΕΕΒΚ/ΕΠ/2025/20