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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: 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 Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Andrea Salonia; Phone Number: +39 0226435661; Email: salonia.andrea@hsr.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • IRCCS Ospedale San Raffaele
    • Contact: Andrea Salonia; Phone Number: +390226435661; Email: salonia.andrea@hsr.it
    • Contact: Nadia Finocchio; Phone Number: +39 0226439425; Email: finocchio.nadia@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the urology department who need undergo prostate biopsy and/or radical prostatectomy surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients underwent prostate biopsy and/or radical prostatectomy surgery.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically significant Prostate Cancer	Diagnosis of clinically significant PCa at prostate biopsy	1 month
Overall survival	Death by any cause	every 6 month after surgery up to 50 years after surgery
Cancer-specific mortality	Death from prostate cancer	every 6 month after surgery up to 50 years after surgery
Biochemical recurrence	PSA >= 0.2 ng/ml in 2 consecutive measures	every 6 month after surgery up to 50 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erectile function	IIEF-EF >=21	every 6 month after surgery up to 50 years after surgery
Urinary continence	No pads over a 24 hour period	every 6 month after surgery up to 50 years after surgery

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2015
• Primary Completion (Estimated): January 8, 2065
• Study Completion (Estimated): January 8, 2065

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2014-Prostata

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No