Prostate CancerNCT06168890
Predictive Role of [11C] Choline PET/CT on Survival in Prostate Cancer Patients With Biochemical Failure.
An observational study of Prostate Cancer, run by IRCCS San Raffaele.
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. 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?
- PET/CT with choline in the restaging phase of prostate cancer.
- How many people
- 195 participants
- Where
- No sites listed yet
- Study dates
- 4 Feb 2014to 25 Feb 2014
- 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 with biochemical recovery of the disease during hormonal therapy who have undergone PET/CT with choline for restaging of the disease after primary treatment.
Who may be able to join
- patients who have been treated with radical prostatectomy;
- patients who present a progressive increase in PSA value during hormonal treatment.
Who cannot join
- patients< 18 years
About this study
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.
- Conditions
- Prostate Cancer
- Being tested
- PET/CT with choline in the restaging phase of prostate cancer.
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT with choline in the restaging phase of prostate cancer.Diagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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 posted13 Dec 2023
- Study start4 Feb 2014
- Primary completion25 Feb 2014
- Study completion25 Feb 2014
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
- 195 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
- NCT06168890
- Sponsor's protocol ID
- PETCT-CHOL
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- 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 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Role of [11C] Choline PET/CT on Survival in Prostate Cancer Patients With Biochemical Failure.
- ClinicalTrials.gov ID
- NCT06168890
- Acronym / sponsor ID
- PETCT-CHOL
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 4 Feb 2014 (actual)
- Primary completion
- 25 Feb 2014 (actual)
- Study completion
- 25 Feb 2014 (actual)
- First posted
- 13 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.
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.
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 with biochemical recovery of the disease during hormonal therapy who have undergone PET/CT with choline for restaging of the disease after primary treatment.
Key inclusion criteria (2 listed)
- patients who have been treated with radical prostatectomy;
- patients who present a progressive increase in PSA value during hormonal treatment.
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 |
|---|---|---|
| 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. | Diagnostic test | – |
Primary outcome
PET CT with choline on the survival of patients with biochemical recovery of prostate cancer
Time frame: 1 year
PET CT with choline on the survival of patients with biochemical recovery of the disease during hormonal therapy.
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 13 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by IRCCS San Raffaele.
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 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 on the survival of patients with biochemical recovery of prostate cancer (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 13 Dec 2023.