NCT06168890

Brief Summary

Several studies have shown that the PET/CT study with Choline is of great use in the restaging of patients with prostate cancer who present a recurrence of biochemical disease following primary treatment. Despite the large amount of literature in which the diagnostic accuracy of the method is highlighted in the identification of the recurrence of prostatic disease both in the case of local recurrence, lymph node recurrence and metastatic disease, there are to date no studies that evaluate whether PET /CT with choline may predict survival in patients radically treated for prostate cancer. The aim of the study is to evaluate the predictive role of choline PET/CT on the survival of patients with biochemical recovery of the disease during hormonal therapy. This retrospective study will include adult patients affected by prostate cancer with biochemical recurrence of the disease following radical prostatectomy treatment and undergoing hormonal therapy who underwent, between 2004 and 2007, a PET/CT study with choline for the restaging of their disease. The expected result is to establish how PET/CT with Choline can predict survival in patients who develop a biochemical recurrence of the disease during hormonal therapy. If this result is confirmed, PET/CT with Choline could be even more useful in the follow-up of patients radically treated for prostate cancer to plan the best therapeutic approach.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 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

February 4, 2014

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2014

Completed
9.8 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

21 days

First QC Date

December 5, 2023

Last Update Submit

December 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • PET CT with choline on the survival of patients with biochemical recovery of prostate cancer

    PET CT with choline on the survival of patients with biochemical recovery of the disease during hormonal therapy.

    1 year

Interventions

PET/CT with choline in the restaging phase of prostate cancer in patients suffering from prostate cancer with biochemical recovery of the disease during hormonal therapy.

Eligibility Criteria

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

Adult patients suffering from prostate cancer with biochemical recovery of the disease during hormonal therapy who have undergone PET/CT with choline for restaging of the disease after primary treatment.

You may qualify if:

  • patients who have been treated with radical prostatectomy;
  • patients who present a progressive increase in PSA value during hormonal treatment.

You may not qualify if:

  • patients\< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

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

December 5, 2023

First Posted

December 13, 2023

Study Start

February 4, 2014

Primary Completion

February 25, 2014

Study Completion

February 25, 2014

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share