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

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Procedure: Radical prostatectomy

• Registration Number: NCT06154499
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

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.

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 Timeline

• Study Start: 2004-04-08
• Study First Submitted: 2023-10-13
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-23
• Last Update Submitted: 2023-11-23
• Study First Posted: 2023-12-04
• Last Update Posted: 2023-12-04
• Primary Completion: 2025-02-13
• Study Completion: 2025-02-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 1784

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients referred to the Urology Department who need to undergo radical prostatectomy surgery	Radical prostatectomy	-

Primary Outcome Measures

Name	Time	Method
Early Urinary continence recovery	6 months after the intervention/procedure/surgery	Continence recovery evaluated with the International Consultation on Incontinence questionnaire - short form (ICIQ-SF), International Prostatic Symptoms Score (IPSS) questionnaires
Early Erectile function recovery	6 months after the intervention/procedure/surgery	Erectile function recovery evaluated with the International Index of Erectile Function (IIEF) questionnaire
Prostate-specific antigen (PSA) persistence or biochemical recurrence	6 months and every year after the intervention/procedure/surgery up to 10 years	Serum PSA levels, conventional imaging

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Francesco Montorsi; 🇮🇹 Milan, Italy