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This study aims to identify patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance who are at higher risk of upgrading to ISUP Grade Group 2 or higher at confirmatory biopsy one year after diagnosis. Patients with low-risk ISUP GG1 tumors will be selected and undergo:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | All patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance will undergo:
Confirmation biopsy one year after diagnosis, according to international guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mpMRI-targeted confirmatory biopsy | Procedure | mpMRI-targeted confirmatory biopsy after one year from the diagnosis, according to the international guidelines |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the Discriminative Ability of a Multivariable Model in Predicting Prostate Cancer Upgrading in Low-Risk Patients Under Active Surveillance" | To determine the discriminative ability of the multivariable model, quantified using the concordance index (c-index), to predict prostate cancer upgrading in low-risk PCa patients managed with active surveillance (AS). | Baseline diagnostic biopsy and 12 months after diagnosis (when the confirmatory biopsy will be performed) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giorgio Gandaglia | Contact | +39 0226438068 | gandaglia.giorgio@hsr.it | |
| Lucia Dambrosio | Contact | dambrosio.lucia@hsr.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Raffaele | Recruiting | Milan | Italy | 20132 | Italy |
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