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.
Study Type
OBSERVATIONAL
Enrollment
20,000
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
IRCCS Ospedale San Raffaele
Milan, Italy
RECRUITINGClinically significant Prostate Cancer
Diagnosis of clinically significant PCa at prostate biopsy
Time frame: 1 month
Overall survival
Death by any cause
Time frame: every 6 month after surgery up to 50 years after surgery
Cancer-specific mortality
Death from prostate cancer
Time frame: every 6 month after surgery up to 50 years after surgery
Biochemical recurrence
PSA \>= 0.2 ng/ml in 2 consecutive measures
Time frame: every 6 month after surgery up to 50 years after surgery
Erectile function
IIEF-EF \>=21
Time frame: every 6 month after surgery up to 50 years after surgery
Urinary continence
No pads over a 24 hour period
Time frame: every 6 month after surgery up to 50 years after surgery
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