NCT06154499

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,784 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Radical prostatectomy	Radical Prostatectomy: surgery to remove the prostate gland and seminal vesicles (and sometimes nearby lymph nodes) after a prostate cancer diagnosis

Timeline

• Start date: 2004-04-08
• Primary completion: 2025-02-13
• Completion: 2025-02-13
• First posted: 2023-12-04
• Last updated: 2023-12-04

Locations

1 site across 1 country: Italy