Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-PSMA1007 PET-CT | Diagnostic Test | — | UNRESOLVED |
| MR-guided TRUS Prostate biopsy | Diagnostic Test | — | UNRESOLVED |
| MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prospective comparison of PSMA PET/CT and MRI-RSI for patients with primary prostate cancer
- description
- MRI-RSI imaging of the prostate (non-invasive)
- interventionNames
- Diagnostic Test: MRI
- Diagnostic Test: 18F-PSMA1007 PET-CT
- Diagnostic Test: MR-guided TRUS Prostate biopsy
Primary outcomes (4)
- measure
- Sensitivity
- timeFrame
- 24 months
- description
- Sensitivity for PSMA PET, conventional mpMRI, MRI-RSI and combined modalities will be calculated on a prostate segment (n=6) level. The prostate cancer distribution in targeted biopsy cores will serve as the ground truth, calculated with the ratio of true positives to the total number of segments with the disease (true positives + false negatives).
- measure
- Absolute GTV volumes
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available