Clinical trial NCT06154499: Archive Prostate. Observational Study of Patients Who Underwent Radical Prostatectomy Surgery
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 1784
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of prostate cancer who need to undergo radical prostatectomy surgery

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.

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.

Eligibility 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

Primary outcomes:
measure: Early Urinary continence recovery
timeFrame: 6 months after the intervention/procedure/surgery
measure: Early Erectile function recovery
timeFrame: 6 months after the intervention/procedure/surgery
measure: Prostate-specific antigen (PSA) persistence or biochemical recurrence
timeFrame: 6 months and every year after the intervention/procedure/surgery up to 10 years
Secondary outcomes:
measure: Urinary continence recovery
timeFrame: every year after the intervention/procedure/surgery up to 10 years
measure: Erectile function recovery
timeFrame: every year after the intervention/procedure/surgery up to 10 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Francesco Montorsi
Study officials:
References: