Archive Prostate. Observational Study of Patients Who Underwent Radical Prostatectomy Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients referred to the Urology Department who need to undergo radical prostatectomy surgery
|
Procedure: Radical prostatectomy
Radical Prostatectomy: surgery to remove the prostate gland and seminal vesicles (and sometimes nearby lymph nodes) after a prostate cancer diagnosis
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Francesco Montorsi | Milan | Italy |
Sponsors and Collaborators
- IRCCS San Raffaele
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2004- Prostata