Prostate CancerNCT06158178
Evaluation of the Predictive Role of Choline PET/CT on the Survival of Patients Affected by Prostate Cancer.
An observational study of Prostate Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. 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
- 520 participants
- Where
- 1 siteItaly
- Study dates
- 8 Aug 2017to 23 Nov 2017
- 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: adult patients suffering from prostate cancer undergoing choline PET/CT at the San Raffaele hospital for restaging of the disease.
Who may be able to join
- adult patients suffering from prostate cancer who have undergone choline PET/TC
Who cannot join
- patients < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
- 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 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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 posted6 Dec 2023
- Study start8 Aug 2017
- Primary completion23 Nov 2017
- Study completion23 Nov 2017
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
- 520 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
- NCT06158178
- Sponsor's protocol ID
- PETCT-Chol-Survival
- Status last verified
- Dec 2023
- First submitted
- 27 Nov 2023
- Last updated
- 6 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 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Predictive Role of Choline PET/CT on the Survival of Patients Affected by Prostate Cancer.
- ClinicalTrials.gov ID
- NCT06158178
- Acronym / sponsor ID
- PETCT-Chol-Survival
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 23 Nov 2017 (actual)
- Study completion
- 23 Nov 2017 (actual)
- First posted
- 6 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 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.
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
- adult patients suffering from prostate cancer undergoing choline PET/CT at the San Raffaele hospital for restaging of the disease.
Key inclusion criteria (1 listed)
- adult patients suffering from prostate cancer who have undergone choline PET/TC
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 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. | Diagnostic test | – |
Primary outcome
Choline PET-CT for the restaging of patients with prostatic disease.
Time frame: 1 year
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.
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 6 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 1 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 6 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?
Choline PET-CT for the restaging of patients with 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 6 Dec 2023.