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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06168890
• Other study ID #: PETCT-CHOL
• Status: Completed
• Start date: February 4, 2014
• Est. completion date: February 25, 2014

Study information

• Verified date: December 2023
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: February 25, 2014
• Est. primary completion date: February 25, 2014
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• PET/CT with choline in the restaging phase of prostate cancer.
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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