NCT06158178

Brief Summary

the increase in the serum PSA (prostate specific antigen) value following radical treatment commonly involves subsequent treatment which, in the absence of morphological evidence of disease recovery, is conducted empirically through local radiotherapy or systemic hormonal therapy. The use of PET with choline is therefore of extreme clinical interest as it allows to identify the site of disease recurrence, thus being able to direct towards a specific therapeutic treatment. The diagnostic accuracy of choline PET in identifying the location of the disease has been widely demonstrated in the literature and is comparable to those of conventional diagnostic methods previously described for the restaging of patients with prostatic disease. The real advantage of this method is the possibility of obtaining the same information as conventional methods by carrying out a single exam.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

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

August 8, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2017

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

November 27, 2023

Last Update Submit

December 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Choline PET-CT for the restaging of patients with prostatic disease.

    By analyzing the data retrospectively, the time elapsed following the prostatectomy operation and the follow up time after the choline PETCT study will be evaluated.

    1 year

Interventions

Diagnostic accuracyDIAGNOSTIC_TEST

The PET CT study with choline, being part of the normal standard diagnostic work-up of the patients, was performed following the normal clinical protocol. By analyzing the data retrospectively, the time elapsed following the prostatectomy operation and the follow up time after the choline PETCT study will be evaluated.

Eligibility Criteria

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

adult patients suffering from prostate cancer undergoing choline PET/CT at the San Raffaele hospital for restaging of the disease.

You may qualify if:

  • adult patients suffering from prostate cancer who have undergone choline PET/TC

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 27, 2023

First Posted

December 6, 2023

Study Start

August 8, 2017

Primary Completion

November 23, 2017

Study Completion

November 23, 2017

Last Updated

December 6, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations