NCT03241758

Brief Summary

A study designed to evaluate vascular changes after radical laparoscopic prostatectomy using Doppler ultrasound and the impact of such changes on erectile function and quality of life of patients. The baseline study will be compared with the study one year after surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

Status
completed

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

November 29, 2011

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
Last Updated

August 7, 2017

Status Verified

August 1, 2017

Enrollment Period

5.7 years

First QC Date

August 3, 2017

Last Update Submit

August 4, 2017

Conditions

Prostatic NeoplasmsErectile Dysfunction Following Radical Prostatectomy

Outcome Measures

Primary Outcomes (3)

  • Left and right Cavernous artery diameter

    mm

    1 year

  • Left and right Systolic velocity cavernous artery

    cm/s

    1 year

  • Left and right Diastolyc velocity cavernous artery

    cm/s

    1 year

Study Arms (1)

Group #1

Patients with prostate cancer who will undergo radical prostatectomy

Diagnostic Test: Doppler ultrasound

Interventions

Doppler ultrasoundDIAGNOSTIC_TEST

Basal Doppler ultrasound and Doppler ultrasound one year after radical prostatectomy

Group #1

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male patients with prostate cancer who underwent laparoscopic radical prostatectomy

You may qualify if:

  • Male patients with prostate cancer who underwent laparoscopic radical prostatectomy

You may not qualify if:

  • Patients who were not interested in their sexual function and refused to perform this study
  • Patients who required adjuvant or salvage treatment for their prostate cancer (radiation therapy, chemotherapy or androgen deprivation therapy) during follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Jesus Muñoz-Rodriguez, MD

    Corporació Sanitaria Parc Tauli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 7, 2017

Study Start

November 29, 2011

Primary Completion

August 2, 2017

Study Completion

August 2, 2017

Last Updated

August 7, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share