Clinical trial · Interventional
Prostate Cancer Secondary Screening in Sapienza and Policlinico Umberto I
A Randomized Controlled Trial on the Role of Magnetic Resonance Imaging for Prostate Cancer Screening
- 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) screening is still a controversial topic in the urology community, this is mostly linked to the low specificity of Prostate Specific Antigen (PSA) value. Screening with total PSA value has cause overdiagnosis of clinically insignificant prostate cancer (ciPCa) for many years, with lack of survival improvement. Non-contrast MRI, on the other hand, has become one of the most promising MRI applications, as it is a more sensitive test able to perform clinically significant PCa early detection. With this background the primary endpoint was to investigate the role of non-contrast MRI (without injection of paramagnetic contrast medium), as a secondary prevention test for the early diagnosis of prostate cancer, comparing it with the serum PSA test, in a randomized fashion.
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 (Diagnosis) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Resonance | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A: patients will perform non-contrast MRI
- description
- A: 355 patients will perform non-contrast MRI regardless their serum PSA value
- interventionNames
- Diagnostic Test: Magnetic Resonance
- type
- EXPERIMENTAL
- label
- B: patients will perform non-contrast MRI
- description
- B: 355 patients will perform non-contrast MRI when serum PSA value is increased (\>4 ng/ml or 2.5 ng/ml if positive family history)
- interventionNames
- Diagnostic Test: Magnetic Resonance
Primary outcomes (1)
- measure
- Diagnosis of prostate cancer with non-contrast MRI
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion criteria: * Males aged between 49-69 years (from the age of 40 for those with family history of prostate cancer) at the time of enrollment * Life expectancy greater than or equal to 10 years * Sufficient understanding of the Italian language for written and verbal understanding of the information for enrollment in the Trial and for the process of obtaining informed consent. * Patient with the ability to understand and want, able to express informed consent and to perform all the visits and procedures required by the study Exclusion criteria: * General contraindications to MRI * Previous history of prostate cancer, prostate biopsy or treatment for prostate cancer * Any contraindications to prostate biopsy, such as severe coagulation abnormalities (INR\> 1.5), active urinary tract infection and acute prostatitis (NIH category I, II and III). * Dementia or altered mental status that would prohibit understanding or granting informed consent
References
Publications (13)
- RESULTEpstein JI, Egevad L, Amin MB, Delahunt B, Srigley JR, Humphrey PA; Grading Committee. The 2014 International Society of Urological Pathology (ISUP) Consensus Conference on Gleason Grading of Prostatic Carcinoma: Definition of Grading Patterns and Proposal for a New Grading System. Am J Surg Pathol. 2016 Feb;40(2):244-52. doi: 10.1097/PAS.0000000000000530. PMID 26492179
- RESULTMatoso A, Epstein JI. Defining clinically significant prostate cancer on the basis of pathological findings. Histopathology. 2019 Jan;74(1):135-145. doi: 10.1111/his.13712. PMID 30565298
- RESULTMottet N, van den Bergh RCN, Briers E, Van den Broeck T, Cumberbatch MG, De Santis M, Fanti S, Fossati N, Gandaglia G, Gillessen S, Grivas N, Grummet J, Henry AM, van der Kwast TH, Lam TB, Lardas M, Liew M, Mason MD, Moris L, Oprea-Lager DE, van der Poel HG, Rouviere O, Schoots IG, Tilki D, Wiegel T, Willemse PM, Cornford P. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2021 Feb;79(2):243-262. doi: 10.1016/j.eururo.2020.09.042. Epub 2020 Nov 7. PMID 33172724
- RESULTWelch HG, Albertsen PC. Reconsidering Prostate Cancer Mortality - The Future of PSA Screening. N Engl J Med. 2020 Apr 16;382(16):1557-1563. doi: 10.1056/NEJMms1914228. No abstract available. PMID 32294352
- RESULTWegelin O, Exterkate L, van der Leest M, Kummer JA, Vreuls W, de Bruin PC, Bosch JLHR, Barentsz JO, Somford DM, van Melick HHE. The FUTURE Trial: A Multicenter Randomised Controlled Trial on Target Biopsy Techniques Based on Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer in Patients with Prior Negative Biopsies. Eur Urol. 2019 Apr;75(4):582-590. doi: 10.1016/j.eururo.2018.11.040. Epub 2018 Dec 3. PMID 30522912
- RESULTTurkbey B, Rosenkrantz AB, Haider MA, Padhani AR, Villeirs G, Macura KJ, Tempany CM, Choyke PL, Cornud F, Margolis DJ, Thoeny HC, Verma S, Barentsz J, Weinreb JC. Prostate Imaging Reporting and Data System Version 2.1: 2019 Update of Prostate Imaging Reporting and Data System Version 2. Eur Urol. 2019 Sep;76(3):340-351. doi: 10.1016/j.eururo.2019.02.033. Epub 2019 Mar 18.