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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Radical prostatectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients referred to the Urology Department who need to undergo radical prostatectomy surgery<br> | Procedure: Radical prostatectomy<br>* Radical Prostatectomy: surgery to remove the prostate gland and seminal vesicles (and sometimes nearby lymph nodes) after a prostate cancer diagnosis<br>|

What is the study measuring?
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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 |