Clinical trial · Interventional
Prostate Cancer Screening: a Pilot Study
Prostate Cancer Screening With PSA, Risk Calculator and Multiparametric MRI: a Pilot Study
- 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 (PCa) is the second most frequently diagnosed tumour and the third most lethal among men in Europe. The lack of precise tools and examinations to precisely diagnose PCa has caused overtreatment of indolent and low-aggressive PCa, while in some other cases, with aggressive disease, diagnosis and treatment are dangerously delayed because cancer could be potentially missed. The present trial aims to study a new pathway to early diagnose PCa with Magnetic Resonance Imaging (MRI) to identify men who will not need treatment and those who will benefit from radical treatment, thus improving disease control and quality of life.
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 |
|---|---|---|---|
| Urology visit with Risk Calculator and MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Subjects with PSA ≥ 3 ng/ml
- description
- * Urologic examination * Risk calculation (ERSPC no.6) * Magnetic resonance imaging * (optional) biopsy
- interventionNames
- Diagnostic Test: Urology visit with Risk Calculator and MRI
Primary outcomes (3)
- measure
- Detection rate of clinically significant prostate cancer (Gleason Group ≥2)
- timeFrame
- 24 months
- description
- No. of detected clinically significant prostate cancer with Gleason Group ≥ 2 over the total no. of men enrolled in the trial
- measure
- Comparison of the detection rate of clinically significant prostate cancer with and without screening
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 55 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * age between 55-65 years; * asymptomatic or paucisymptomatic from a urological point of view; * no previous prostate biopsy; * living in the ASL TO5 (Piedmont, Italy); * signed written informed consent. Exclusion Criteria: * positive oncologic anamnesis for prostate cancer; * previous biopsy or prostate surgery; * previous radiotherapy of the pelvis; * any contraindication to MRI examination; * claustrophobic or uncollaborative subjects.
References
Publications (0)
Data not yet available