Archive Prostate. Observational Study of Patients Who Underwent Radical Prostatectomy Surgery

Archive Prostate. Observational Study of Patients Who Underwent Radical Prostatectomy Surgery. Long-term Evaluation of the Course of Prostate Cancer Associated With Quality of Life, Post-surgery Treatments and Occurrence of Any Disease Recurrence

This is a single-center, observational, prospective study on quality of life and disease status of patients who underwent radical prostatectomy. Data related to clinical conditions (oncological, psychological, sexual and quality of life) of these patients are collected in a database.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Radical prostatectomy

Detailed Description

A database was created with the intention of collecting data related to patients with diagnosis of prostate cancer who underwent radical prostatectomy.

Anamnesis, surgery, histological report and hospitalization data are collected for patients who underwent radical prostatectomy.

Each patient will be followed for 10 years from the date of radical prostatectomy surgery.

Each patient will receive a questionnaire before radical prostatectomy in order to evaluate the quality of life (urinary continence, erectile function and psycho-physical wellbeing). A follow up questionnaire will be collected after surgery in order to analyze the predictive factors of the disease, clinical progression and to obtain health benefits for the patients involved and for future patients with the same tipe of cancer, improving the scientific knowledge of the pathology and implementing new strategies for diagnosis and therapy and evaluating the epidemiologic changes of prostate cancer. Tha data collected will be handles following the most strict Good Clinical Practice (GCPs) and privacy norms.

• Study Type: Observational
• Enrollment (Actual): 1784

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Francesco Montorsi

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of prostate cancer who need to undergo radical prostatectomy surgery

Description

Inclusion Criteria:

• Patients with prostate cancer who underwent 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 referred to the Urology Department who need to undergo radical prostatectomy surgery	Procedure: Radical prostatectomy; 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
Early Urinary continence recovery	Continence recovery evaluated with the International Consultation on Incontinence questionnaire - short form (ICIQ-SF), International Prostatic Symptoms Score (IPSS) questionnaires	6 months after the intervention/procedure/surgery
Early Erectile function recovery	Erectile function recovery evaluated with the International Index of Erectile Function (IIEF) questionnaire	6 months after the intervention/procedure/surgery
Prostate-specific antigen (PSA) persistence or biochemical recurrence	Serum PSA levels, conventional imaging	6 months and every year after the intervention/procedure/surgery up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary continence recovery	Continence recovery evaluated with the International Consultation on Incontinence	every year after the intervention/procedure/surgery up to 10 years
Erectile function recovery	Erectile function recovery evaluated with the International Index of Erectile Function (IIEF)	every year after the intervention/procedure/surgery up to 10 years

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2004
• Primary Completion (Estimated): February 13, 2025
• Study Completion (Estimated): February 13, 2025

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: November 23, 2023
• First Posted (Actual): December 4, 2023

Study Record Updates

• Last Update Posted (Actual): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

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: 2004- 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