CClinicalTrials.gg
CompletedNCT06168890Updated Dec 13, 2023

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

An observational study in Prostate Cancer, sponsored by IRCCS San Raffaele. Completed. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-13.

Sponsored by IRCCS San Raffaele · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
195
Ages
18 Years and older
Sex
Male
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Study 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.

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Conditions studied

  • Prostate Cancer

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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 195 is close to the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Sampling method
Probability 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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients\< 18 years
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
195 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testPET/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.

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What researchers measure

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.

    Time frame: 1 year

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06168890
Lead sponsor
IRCCS San Raffaele
Responsible party
Chiti Arturo (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, IRCCS San Raffaele) — Principal investigator
First posted
Dec 13, 2023
Start date
Feb 4, 2014
Primary completion
Feb 25, 2014
Completion
Feb 25, 2014
Last update
Dec 13, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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