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

San Donato Group (GSD)

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Procedure: Radical prostatectomy

Study type: Observational

Funder types: Other

Identifiers

NCT06154499

2004- Prostata

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,784 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,784 participants in 1 patient group

Patients referred to the Urology Department who need to undergo radical prostatectomy surgery

Treatment:

Procedure: Radical prostatectomy