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

NCT06397755 | Recruiting

• 1 other identifier: 2014-Prostata
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Erectile function

  every 6 month after surgery up to 50 years after surgery

• Urinary continence

  every 6 month after surgery up to 50 years after surgery

Study Arms (1)

Patients underwent prostate biopsy and/or radical prostatectomy surgery.

Procedure: Prostate Biopsy and/or Radical Prostatectomy

Interventions

Prostate Biopsy and/or Radical Prostatectomy PROCEDURE

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

Patients underwent prostate biopsy and/or radical prostatectomy surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Andrea Salonia

CONTACT

+39 0226435661; salonia.andrea@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: May 3, 2024
• Study Start: January 8, 2015
• Primary Completion (Estimated): January 8, 2065
• Study Completion (Estimated): January 8, 2065
• Last Updated: May 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)