Prostate Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREProstate Biopsy and/or Radical Prostatectomy
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
Sponsors
IRCCS San Raffaele
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a suspicious prostate disease who underwent prostate biopsy and/or radical prostatectomy; * Adult patients \> 18 years * Ability to read and sign the informed consent
Exclusion criteria
* Patients \< 18 years * mental or physical disability that may prevent the patient from satisfying the requirements of the protocol * Inability to read and sign the informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically significant Prostate Cancer | 1 month | Diagnosis of clinically significant PCa at prostate biopsy |
| Overall survival | every 6 month after surgery up to 50 years after surgery | Death by any cause |
| Cancer-specific mortality | every 6 month after surgery up to 50 years after surgery | Death from prostate cancer |
| Biochemical recurrence | every 6 month after surgery up to 50 years after surgery | PSA \>= 0.2 ng/ml in 2 consecutive measures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erectile function | every 6 month after surgery up to 50 years after surgery | IIEF-EF \>=21 |
| Urinary continence | every 6 month after surgery up to 50 years after surgery | No pads over a 24 hour period |
Countries
Italy
Contacts
Primary ContactAndrea Salonia
Outcome results
None listed