Prostate CancerNCT06167824
Assessment of Predictive Role of [11C] Choline PET/CT on Survival in Prostate Cancer Patients With Biochemical Failure Without Androgen Deprivation Therapy
An observational study of Prostate Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Among all the patients who underwent PET/CT with choline at our Institute between 2004 and 2007 to restage the prostatic disease following biochemical recovery of the disease, in this retrospective study the patients previously treated with radical prostatectomy, who present a progressive increase in the PSA value in… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 302 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jun 2014to 15 Jul 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: patients previously treated with radical prostatectomy, with progressive increase in PSA value in the absence of hormonal therapy and for whom there is knowledge of the main clinical and follow up data with particular attention to survival data.
Who may be able to join
- patients previously treated with radical prostatectomy, with progressive increase in PSA value in the absence of hormonal therapy.
Who cannot join
- < 18 years patients
Trial locations and contacts
1 site in 1 country.
About this study
Among all the patients who underwent PET/CT with choline at our Institute between 2004 and 2007 to restage the prostatic disease following biochemical recovery of the disease, in this retrospective study the patients previously treated with radical prostatectomy, who present a progressive increase in the PSA value in the absence of hormone therapy and of which there is knowledge of the main clinical and follow-up data, with particular attention to survival data.
The PET/CT study with Choline, being part of the normal standard diagnostic work-up of patients, was performed following the normal clinical protocol. With the retrospective analysis of the data, the time elapsed following the prostatectomy operation and the follow-up time after the Choline PET/CT study will be evaluated and patients who died due to prostate cancer will therefore be considered. Prostate cancer-specific survival, calculated as the interval between radical prostatectomy and death due to prostate cancer, will be used as the end point. The differences between prostate cancer-specific survival of patients with a positive choline PET/CT study and patients with a negative choline PET/CT study will be evaluated (log-rank test). Choline PET/CT will be considered positive if pathological findings with significant tracer uptake are identified. In the subpopulation of patients with a positive Choline PET/CT study, survival data will also be evaluated in relation to the site of positivity of the PET/CT study, in particular at the level of local recurrence, in the lymph node or skeletal site.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
PET/CT with coline in patients previously treated with radical prostatectomy.
Retrospective observational study with 302 patients with prostate cancer were considered.
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 start19 Jun 2014
- Primary completion15 Jul 2014
- Study completion15 Jul 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
- 302 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
- NCT06167824
- Sponsor's protocol ID
- PETCT-CHOL-SURVIVAL-TREATMENT
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2023
- Last updated
- 13 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 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Predictive Role of [11C] Choline PET/CT on Survival in Prostate Cancer Patients With Biochemical Failure Without Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT06167824
- Acronym / sponsor ID
- PETCT-CHOL-SURVIVAL-TREATMENT
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 19 Jun 2014 (actual)
- Primary completion
- 15 Jul 2014 (actual)
- Study completion
- 15 Jul 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.
Among all the patients who underwent PET/CT with choline at our Institute between 2004 and 2007 to restage the prostatic disease following biochemical recovery of the disease, in this retrospective study the patients previously treated with radical prostatectomy, who present a progressive increase in the PSA value in the absence of hormone therapy and of which there is knowledge of the main clinical and follow-up data, with particular attention to survival data.
The PET/CT study with Choline, being part of the normal standard diagnostic work-up of patients, was performed following the normal clinical protocol. With the retrospective analysis of the data, the time elapsed following the prostatectomy operation and the follow-up time after the Choline PET/CT study will be evaluated and patients who died due to prostate cancer will therefore be considered. Prostate cancer-specific survival, calculated as the interval between radical prostatectomy and death due to prostate cancer, will be used as the end point. The differences between prostate cancer-specific survival of patients with a positive choline PET/CT study and patients with a negative choline PET/CT study will be evaluated (log-rank test). Choline PET/CT will be considered positive if pathological findings with significant tracer uptake are identified. In the subpopulation of patients with a positive Choline PET/CT study, survival data will also be evaluated in relation to the site of positivity of the PET/CT study, in particular at the level of local recurrence, in the lymph node or skeletal site.
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
- patients previously treated with radical prostatectomy, with progressive increase in PSA value in the absence of hormonal therapy and for whom there is knowledge of the main clinical and follow up data with particular attention to survival data.
Key inclusion criteria (1 listed)
- patients previously treated with radical prostatectomy, with progressive increase in PSA value in the absence of hormonal therapy.
Key exclusion criteria (1 listed)
- < 18 years patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PET/CT with coline in patients previously treated with radical prostatectomy.
Time frame: 1 year
Retrospective observational study with 302 patients with prostate cancer were considered.
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.
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 13 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 coline in patients previously treated with radical prostatectomy. (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.