Predictive Role of [11C] Choline PET/CT on Survival in Prostate Cancer Patients With Biochemical Failure.

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT06168890
• Lead Sponsor: IRCCS San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-04
• Primary Completion: 2014-02-25
• Study Completion: 2014-02-25
• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-05
• Last Update Submitted: 2023-12-05
• Study First Posted: 2023-12-13
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 195

Inclusion Criteria

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

Exclusion Criteria

• patients< 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PET CT with choline on the survival of patients with biochemical recovery of prostate cancer	1 year	PET CT with choline on the survival of patients with biochemical recovery of the disease during hormonal therapy.