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CompletedNCT06158178Updated Dec 6, 2023

Evaluation of the Predictive Role of Choline PET/CT on the Survival of Patients Affected by Prostate Cancer.

An observational study in Prostate Cancer, sponsored by IRCCS San Raffaele. Completed at 1 site in Italy. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-06.

Sponsored by IRCCS San Raffaele · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
520
Ages
18 Years and older
Sex
Male
01

Study 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.

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Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's enrollment of 520 is above the median of 200 across 1,179 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 undergoing choline PET/CT at the San Raffaele hospital for restaging of the disease.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients \< 18 years
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Study design

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

Interventions

  • Diagnostic testDiagnostic accuracy

    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.

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What researchers measure

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.

    Time frame: 1 year

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Study locations

1 site
  • Irccs San Raffaele
    Milano, Italia, Italy
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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 6, 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
NCT06158178
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 6, 2023
Start date
Aug 8, 2017
Primary completion
Nov 23, 2017
Completion
Nov 23, 2017
Last update
Dec 6, 2023

Oversight

Data monitoring committee
Yes
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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