NCT04219059

Brief Summary

A combination of correct interpretation of imaging and biopsy has given promising results in terms of detecting clinically significant cancer at radical prostatectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

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

September 3, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

1.6 years

First QC Date

December 25, 2019

Last Update Submit

January 24, 2023

Conditions

Prostate Cancer

Keywords

cancerprostateradiomicsMRIprognostic factors

Outcome Measures

Primary Outcomes (1)

  • Number of surrogate bioimaging markers of histological characteristics in MR images

    Segment tumor volumes on the ADC map and extract different imaging features

    0-2 years

Secondary Outcomes (2)

  • Radiomic features from MRI

    0-2 years

  • Extract radiomic features

    0-2 years

Eligibility Criteria

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

200 male patients who have a pre-intervention prostate MRI with contrast agent from December 2015 to August 30, 2019 and biopsy proven Pca diagnosis, followed by radical prostatectomy will be evaluated.

You may qualify if:

  • \> 18 years of age
  • In house MRI with contrast medium
  • PCa (prostate cancer) biopsy proven diagnosis
  • In house radical prostatectomy

You may not qualify if:

  • \< 18 years of age
  • MRI without contrast medium
  • Radical prostatectomy executed not in Institution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20153, Italy

Location

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Radiology Department

Study Record Dates

First Submitted

December 25, 2019

First Posted

January 6, 2020

Study Start

September 3, 2019

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations

IT(1)