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

Recruiting

• Conditions: Prostate Cancer
• Interventions: Procedure: Prostate Biopsy and/or Radical Prostatectomy

• Registration Number: NCT06397755
• Lead Sponsor: IRCCS San Raffaele

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.

Study Timeline

• Study Start: 2015-01-08
• Study First Submitted: 2023-10-13
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-29
• Last Update Submitted: 2024-04-29
• Study First Posted: 2024-05-03
• Last Update Posted: 2024-05-03
• Primary Completion: 2065-01-08
• Study Completion: 2065-01-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 20000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients underwent prostate biopsy and/or radical prostatectomy surgery.	Prostate Biopsy and/or Radical Prostatectomy	-

Primary Outcome Measures

Name	Time	Method
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
Biochemical recurrence	every 6 month after surgery up to 50 years after surgery	PSA \>= 0.2 ng/ml in 2 consecutive measures
Cancer-specific mortality	every 6 month after surgery up to 50 years after surgery	Death from prostate cancer

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy