NCT06397755

Observational Study of Patients Who Underwent Diagnostic Investigation (Prostate Biopsy) and/or Radical Prostatectomy Surgery.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20,000 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Prostate 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

Timeline

• Start date: 2015-01-08
• Primary completion: 2065-01-08
• Completion: 2065-01-08
• First posted: 2024-05-03
• Last updated: 2024-05-03

Locations

1 site across 1 country: Italy