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To assess prostate cancer (PCa) detection rate in men undergoing magnetic resonance imaging (MRI) before planning prostate biopsy. Results will be stratified considering men with/without previous negative prostate biopsy.
Secondary objective will be to compute the negative predictive value of MRI in subject with no lesion detected at imaging or no cancer confirmed at biopsy, considering a follow-up of at least 2 years.
The trial is a retrospective observational study, with the aim to compare two cohorts of patients with suspicion of PCa who will undergo MRI. Group A is composed by patients with previous negative biopsy, while group B is composed by men with no previous negative prostate biopsy.
To reach primary aim, men with positive MRI (clinically significant lesions with PI-RADS score >= 3) and biopsy data will be considered.
In men with negative MRI (clinically insignificant lesions or regions classified as PI-RADS 2 at MRI), follow-up with PSA data and repeated MRI and/or biopsy will be considered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (previous negative biopsy) | Men with clinical suspicion of PCa, previous negative prostate biopsy who underwent prostate MRI |
| |
| Group B (biopsy naive) | Men with clinical suspicion of PCa, no previous negative prostate biopsy who underwent prostate MRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multiparametric MRI | Diagnostic Test | T1-w, T2-w, diffusion weighted and dynamic contrast-enhanced imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| PCa detection rate | Number of men with positive prostate biopsy over the number of men with a positive MRI | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Negative predictive value of MRI | Number of men with negative MRI or positive MRI but negative biopsy who are confirmed as negative for PCa during the follow-up over the total number of subjects considered during the follow-up | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Men with clinical suspicion of PCa, eligible for prostate biopsy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute | Candiolo | Turin | 10060 | Italy |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000081364 | Multiparametric Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D003933 | Diagnosis |