Prostate CancerNCT06170164
Radiation Treatment of Lymph Node Recurrence From Prostate Cancer : is 11C-choline PET/CT Predictive of Survival Outcomes?
An observational study of Prostate Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The role of PET/CT with Choline in the restaging of prostatic disease is now universally recognized, and its use has become routine in numerous centers in Italy and abroad. The indication for the test is provided exclusively by an increase in PSA. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Diagnostic accuracy
- How many people
- 68 participants
- Where
- 1 siteItaly
- Study dates
- 8 Oct 2015to 25 Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
Study population: The study is retrospective observational and the results of the choline PET diagnostic tests of 68 patients performed at our center from 2005 to 2013 were reviewed.
Who may be able to join
- patients operated with radical prostatectomy
- patients that present biochemical recurrence of the disease;
Who cannot join
- patients <18 years
Trial locations and contacts
1 site in 1 country.
About this study
The role of PET/CT with Choline in the restaging of prostatic disease is now universally recognized, and its use has become routine in numerous centers in Italy and abroad. The indication for the test is provided exclusively by an increase in PSA. It was interesting to understand whether these prognostic factors have an influence on the probability of detecting disease by PET with Choline to identify patients who have a greater probability of benefiting from the use of this method with the possibility of identifying the disease in earlier stages.
- Conditions
- Prostate Cancer
- Being tested
- Diagnostic accuracy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic accuracyDiagnostic test
The aim of the study is to evaluate whether the pathological stage of the disease, Gleason score, age at diagnosis, serum PSA value and PET parameters (SUV, MTV) are predictive factors of choline PET examination.
What is being measured
The primary outcome is the main question the study is designed to answer.
PET/CT with Choline in the restaging of prostatic disease.
retrospective analysis of 68 patients with biochemical recurrence of prostase disease that performed PET/CT with choline for the restaging of the disease.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start8 Oct 2015
- Primary completion25 Nov 2015
- Study completion25 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiti Arturo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170164
- Sponsor's protocol ID
- Colina-HTT-LN
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Treatment of Lymph Node Recurrence From Prostate Cancer : is 11C-choline PET/CT Predictive of Survival Outcomes?
- ClinicalTrials.gov ID
- NCT06170164
- Acronym / sponsor ID
- Colina-HTT-LN
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 8 Oct 2015 (actual)
- Primary completion
- 25 Nov 2015 (actual)
- Study completion
- 25 Nov 2015 (actual)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The role of PET/CT with Choline in the restaging of prostatic disease is now universally recognized, and its use has become routine in numerous centers in Italy and abroad. The indication for the test is provided exclusively by an increase in PSA. It was interesting to understand whether these prognostic factors have an influence on the probability of detecting disease by PET with Choline to identify patients who have a greater probability of benefiting from the use of this method with the possibility of identifying the disease in earlier stages.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- The study is retrospective observational and the results of the choline PET diagnostic tests of 68 patients performed at our center from 2005 to 2013 were reviewed.
Key inclusion criteria (2 listed)
- patients operated with radical prostatectomy
- patients that present biochemical recurrence of the disease;
Key exclusion criteria (1 listed)
- patients <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic accuracyThe aim of the study is to evaluate whether the pathological stage of the disease, Gleason score, age at diagnosis, serum PSA value and PET parameters (SUV, MTV) are predictive factors of choline PET examination. | Diagnostic test | – |
Primary outcome
PET/CT with Choline in the restaging of prostatic disease.
Time frame: 1 year
retrospective analysis of 68 patients with biochemical recurrence of prostase disease that performed PET/CT with choline for the restaging of the disease.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET/CT with Choline in the restaging of prostatic disease. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.