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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06397755
• Other study ID #: 2014-Prostata
• Status: Recruiting
• Start date: January 8, 2015
• Est. completion date: January 8, 2065

Study information

• Verified date: April 2024
• Source: IRCCS San Raffaele
• Contact: Andrea Salonia
• Phone: +39 0226435661
• Email: salonia.andrea[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: January 8, 2065
• Est. primary completion date: January 8, 2065
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically significant Prostate Cancer	Diagnosis of clinically significant PCa at prostate biopsy	1 month
Primary	Overall survival	Death by any cause	every 6 month after surgery up to 50 years after surgery
Primary	Cancer-specific mortality	Death from prostate cancer	every 6 month after surgery up to 50 years after surgery
Primary	Biochemical recurrence	PSA >= 0.2 ng/ml in 2 consecutive measures	every 6 month after surgery up to 50 years after surgery
Secondary	Erectile function	IIEF-EF >=21	every 6 month after surgery up to 50 years after surgery
Secondary	Urinary continence	No pads over a 24 hour period	every 6 month after surgery up to 50 years after surgery