NCT06170164

Brief Summary

The role of PET/CT with Choline in the restaging of prostatic disease is now universally recognized, and its use has become routine in numerous centers in Italy and abroad. The indication for the test is provided exclusively by an increase in PSA. It was interesting to understand whether these prognostic factors have an influence on the probability of detecting disease by PET with Choline to identify patients who have a greater probability of benefiting from the use of this method with the possibility of identifying the disease in earlier stages.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

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

October 8, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2015

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

November 28, 2023

Last Update Submit

December 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • PET/CT with Choline in the restaging of prostatic disease.

    retrospective analysis of 68 patients with biochemical recurrence of prostase disease that performed PET/CT with choline for the restaging of the disease.

    1 year

Interventions

Diagnostic accuracyDIAGNOSTIC_TEST

The aim of the study is to evaluate whether the pathological stage of the disease, Gleason score, age at diagnosis, serum PSA value and PET parameters (SUV, MTV) are predictive factors of choline PET examination.

Eligibility Criteria

Age18 Years+
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study is retrospective observational and the results of the choline PET diagnostic tests of 68 patients performed at our center from 2005 to 2013 were reviewed.

You may qualify if:

  • patients operated with radical prostatectomy
  • patients that present biochemical recurrence of the disease;

You may not qualify if:

  • patients \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irccs San Raffaele

Milan, Italia, 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
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Diagnostic Imaging and Radiotherapy Faculty of Medicine and Surgery, Vita-Salute San Raffaele University Director, Department of Nuclear Medicine, IRCCS Ospedale San Raffaele

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 14, 2023

Study Start

October 8, 2015

Primary Completion

November 25, 2015

Study Completion

November 25, 2015

Last Updated

December 14, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations