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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06154499
• Other study ID #: 2004- Prostata
• Status: Active, not recruiting
• Start date: April 8, 2004
• Est. completion date: February 13, 2025

Study information

• Verified date: November 2023
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1784
• Est. completion date: February 13, 2025
• Est. primary completion date: February 13, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Radical prostatectomy
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	Francesco Montorsi	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	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
Primary	Early Erectile function recovery	Erectile function recovery evaluated with the International Index of Erectile Function (IIEF) questionnaire	6 months after the intervention/procedure/surgery
Primary	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	Urinary continence recovery	Continence recovery evaluated with the International Consultation on Incontinence	every year after the intervention/procedure/surgery up to 10 years
Secondary	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