NCT06154499

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,784

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2004

Completed
19.5 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2025

Completed
Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

20.9 years

First QC Date

October 13, 2023

Last Update Submit

November 23, 2023

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Urinary continence recovery

    every year after the intervention/procedure/surgery up to 10 years

  • Erectile function recovery

    every year after the intervention/procedure/surgery up to 10 years

Study Arms (1)

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

Procedure: Radical prostatectomy

Interventions

Radical prostatectomyPROCEDURE

Radical Prostatectomy: surgery to remove the prostate gland and seminal vesicles (and sometimes nearby lymph nodes) after a prostate cancer diagnosis

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

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a diagnosis of prostate cancer who need to undergo radical prostatectomy surgery

You may qualify if:

  • Patients with prostate cancer who underwent radical prostatectomy;
  • Adult patients \> 18 years
  • Ability to read and sign the informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Francesco Montorsi

Milan, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 13, 2023

First Posted

December 4, 2023

Study Start

April 8, 2004

Primary Completion

February 13, 2025

Study Completion

February 13, 2025

Last Updated

December 4, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)