Clinical trial · Observational
The Value of PSMA-PET Compared With Multi-parametric MRI in the Detection Prostate Lesions
Evaluation of the Added Value of PSMA-PET Compared With Multi-parametric MRI in the Detection and Classification of Prostate Lesions
- 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)
Prostate cancer is a common disease in men. In prostate 35% of biopsies, usually done due to increased PSA levels or clinical suspicion, are false negative, despite malignancy. Multi-parametric prostate MRI detects malignant neoplasm lesions better than other imaging devices. A sonar-guided prostate biopsy based on multi-parametric MRI images improves detection of malignancy. Ga68 PSMA-PET test uses a radioactive marker that binds to the prostate's cells and is shown to be a primary prostate tumor site in addition to metastasis. We believe that the combination of measures from a single Ga68 PSMA and multi-parametric MRI test can lead to further improvement in malignancy, better biopsy guidance, and optimal treatment for the patient.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Patients with no clear lesion in PET or MRI
- description
- If the clinical suspicion of cancer is low, there will be no biopsy, only follow-up. If the decision is to perform a biopsy on the prostate, it will be performed with transrectal sonar guidance and systematic biopsies will be performed (12 samples will be taken from different areas of the prostate)
- label
- Patients with MRI lesions and overlapping mapping lesions
- description
- If MRI and PET are matched, a US FUSION MRI biopsy will be taken between 4-8 samples directly from the lesion as well as other systemic prostate samples according to the surgeon's decision. Will be taken and sent separately to pathology.
- interventionNames
- Procedure: Biopsy
- label
- Patients with a discrepancy between the PET and MRI
- description
- A FUSION approach will be biopsy. Four to eight samples for each lesion, as well as other systemic prostate samples will be taken according to the surgeon's decision, and the samples will be marked and sent separately to the pathology.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men aged 40 and over. 2. Patients with clinical suspicion of prostate cancer, referred for multi parametric MRI Exclusion Criteria: 1. Are unable to perform multi-parameter MRI (eg GFR below 30, metals in the body, claustrophobia, etc.). 2. Can not / want to sign informed consent form.
References
Publications (0)
Data not yet available