Observational Study of Patients Who Underwent Diagnostic Investigation (Prostate Biopsy) and/or Radical Prostatectomy Surgery.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prostate Biopsy and/or Radical Prostatectomy.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Clinically significant Prostate Cancer [Time frame: 1 month]
- Overall survival [Time frame: every 6 month after surgery up to 50 years after surgery]
- Cancer-specific mortality [Time frame: every 6 month after surgery up to 50 years after surgery]
- Biochemical recurrence [Time frame: every 6 month after surgery up to 50 years after surgery]
Secondary outcome measures (2)
- Erectile function [Time frame: every 6 month after surgery up to 50 years after surgery]
- Urinary continence [Time frame: every 6 month after surgery up to 50 years after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Ospedale San Raffaele — Milan
Identifiers
NCT: NCT06397755 · 2014-Prostata