IRCCS Ospedale San Raffaele
Milan, Italy
Location status: Recruiting
Location contact
Andrea Salonia
CONTACT
Nadia Finocchio
CONTACT
NCT Number: NCT06397755
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.
Interested in participating?
Request Info18 year and older
Male
Observational
Milan, Italy
Location status: Recruiting
Andrea Salonia
CONTACT
Nadia Finocchio
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 1 month
Diagnosis of clinically significant PCa at prostate biopsy
Time frame: every 6 month after surgery up to 50 years after surgery
Death by any cause
Time frame: every 6 month after surgery up to 50 years after surgery
Death from prostate cancer
Time frame: every 6 month after surgery up to 50 years after surgery
PSA >= 0.2 ng/ml in 2 consecutive measures
Time frame: every 6 month after surgery up to 50 years after surgery
IIEF-EF >=21
Time frame: every 6 month after surgery up to 50 years after surgery
No pads over a 24 hour period
Contact information is provided by the study sponsor or research team.
IRCCS San Raffaele
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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