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This is a single-center, observational, prospective and retrospective study on quality of life and disease status of patients who underwent prostate biopsy and/or radical prostatectomy.
A database was created with the intention of collecting data related to patients who underwent prostate biopsy and/or radical prostatectomy.
Only anamnesis and biopsy procedure data are collected for patients underwent prostate biopsy.
Anamnesis, surgery, histological report and hospitalization data are collected for patients who underwent radical prostatectomy.
Each patient will be followed for 50 years from the date of radical prostatectomy surgery.
Each patient will receive a questionnaire before radical prostatectomy. A follow up questionnaire will be collected after surgery relating to quality of life. The data for each patient will then be transferred to the database itself. The data collected will be handled following the most strict GCPs and privacy norms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients underwent prostate biopsy and/or radical prostatectomy surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostate Biopsy and/or Radical Prostatectomy | Procedure | Prostate Biopsy: procedure to remove samples of suspicious tissue from the prostate Radical Prostatectomy: surgery to remove the prostate gland and seminal vesicles (and sometimes nearby lymph nodes) after a prostate cancer diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically significant Prostate Cancer | Diagnosis of clinically significant PCa at prostate biopsy | 1 month |
| Overall survival | Death by any cause | every 6 month after surgery up to 50 years after surgery |
| Cancer-specific mortality | Death from prostate cancer | every 6 month after surgery up to 50 years after surgery |
| Biochemical recurrence | PSA >= 0.2 ng/ml in 2 consecutive measures | every 6 month after surgery up to 50 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Erectile function | IIEF-EF >=21 | every 6 month after surgery up to 50 years after surgery |
| Urinary continence | No pads over a 24 hour period |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to the urology department who need undergo prostate biopsy and/or radical prostatectomy surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Salonia | Contact | +39 0226435661 | salonia.andrea@hsr.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Raffaele | Recruiting | Milan | 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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|
| every 6 month after surgery up to 50 years after surgery |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |