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

San Donato Group (GSD)

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Procedure: Prostate Biopsy and/or Radical Prostatectomy

Study type: Observational

Funder types: Other

Identifiers

NCT06397755

2014-Prostata

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20,000 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20,000 participants in 1 patient group

Patients underwent prostate biopsy and/or radical prostatectomy surgery.

Treatment:

Procedure: Prostate Biopsy and/or Radical Prostatectomy