Clinical trial · Interventional
Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers
- 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)
This study will enroll 200 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 2.5 ng/ml or abnormal digital rectal examination. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 3 Tesla (T) magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer. Targeted TRUS guided biopsy based on MRI findings will be performed in addition to routine twelve core TRUS biopsy. Moreover, selected serum and urine biomarkers as well as biomarkers extracted from fresh biopsy sample will be collected and correlated with the presence or absence of prostate cancer.
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 |
|---|---|---|---|
| Prostate MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- MRI and biomarkers
- description
- Prostate MRI. Blood and urine biomarkers. Both prior to biopsy. Tissue samples during prostatectomy.
- interventionNames
- Other: Prostate MRI
Primary outcomes (1)
- measure
- Sensitivity, specificity and accuracy of MRI and DWI at 3T magnetic field for the detection of prostate cancer in correlation with systematic TRUS guided biopsy
- timeFrame
- Baseline (MRI prior to prostate biopsy)
Secondary outcomes (1)
- measure
- Sensitivity, specificity and accuracy of selected serum, urine and tissue biomarkers for detection of prostate cancer
- timeFrame
- Baseline and during procedure
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 40 to 85 years * Language spoken: Finnish * Clinical suspicion of prostate cancer, based on: serum level of PSA from 2,5 ng/ml to 25 ng/ml in two following measurements and/or abnormal digital rectal examination * Mental status: Patients must be able to understand the meaning of the study * Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff Exclusion Criteria: * previous prostate biopsies * previous diagnosis of prostate carcinoma * previous prostate surgeries, e.g. TURP (transurethral prostatic resection) * symptomatic of acute prostatitis * contraindications for MRI (cardiac pacemaker, intracranial clips etc) * uncontrolled serious infection * claustrophobia * any other conditions that might compromise patients safety, based on the clinical judgment of the responsible urologist
References
Publications (0)
Data not yet available