Prostate CancerNCT06179706
11C-choline PET/CT Based Helical Tomotherapy as Innovative Treratment Approach for Bone Metastases in Prostate Cancer Patients.
An observational study of Prostate Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The number of metastases may reflect the biological aggressiveness of the tumor and may determine the possibility of performing potential curative interventions such as surgery or high-dose targeted radiotherapy (RT). 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?
- 11C-choline PET/CT
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 27 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: patients suffering from prostate cancer who have undergone primary curative treatment and who have presented biochemical recurrence of the disease.
Who may be able to join
- patients diagnosed with less than 3 bone lesions found on C11-Choline PET/CT
- availability of clinical follow-up using serial PSA assays.
Who cannot join
- <18 years patients
Trial locations and contacts
1 site in 1 country.
About this study
The number of metastases may reflect the biological aggressiveness of the tumor and may determine the possibility of performing potential curative interventions such as surgery or high-dose targeted radiotherapy (RT). Until a few years ago, the treatment of choice for metastatic prostate cancer was androgen deprivation (TDA). This treatment was carried out as palliative care in order to postpone the progression of the disease or reduce symptoms. Patients with prostate cancer with a limited number of metastases, similarly to patients suffering from other solid tumors, can be considered as patients with disease that has limited capacity to cause further secondary effects. In this scenario, the primary treatment in patients with carcinoma localized prostate, is characterized by radical prostatectomy, followed by measurement of prostate specific antigen (PSA) during follow-up. After primary prostatectomy, PSA values > 0.2 ng/mL are indicative of disease recurrence, but it is not possible to determine whether the recurrence is local or distant. Furthermore, imaging modalities, such as bone scanning and computed tomography (CT), do not have sufficient sensitivity to detect the presence of metastatic disease in patients with low PSA levels. Positron emission tomography/CT with 11C-choline is able to detect local or distant metastases with a sensitivity and specificity greater than 85% in patients with biochemical disease recurrence. 11C-Choline PET/CT can be a valid tool both for diagnosis and for guiding radiotherapy treatments in these patients for whom it is not possible to obtain a definitive diagnosis with conventional diagnostic procedures. There are currently few studies that have described the use of 11C-choline PET/CT to guide treatment for bone metastases; the limitations of these studies concern the small number of patients and the short follow-up. The aim of this retrospective observational study was to evaluate the efficacy of 11C-choline PET/CT as a guide to the treatment of helical tomotherapy for an innovative therapeutic approach in bone metastases in a population of patients affected by prostate cancer with a limited number of metastasis.
- Conditions
- Prostate Cancer
- Being tested
- 11C-choline PET/CT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-choline PET/CTDiagnostic test
In our study we evaluated the efficacy of high-dose RT guided by 11C-Choline PET/CT on bone metastases in prostate cancer patients with a limited number of metastases.
What is being measured
The primary outcome is the main question the study is designed to answer.
11C-choline PET/CT to the treatment of patients with prostate cancer with a limited number of metastasis.
Retrospective observational study with 11C-choline PET/CT for the treatment of helical tomotherapy for an innovative therapeutic approach in bone metastases in a population of patients affected by prostate cancer.
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 posted22 Dec 2023
- Study start27 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
- 20 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
- NCT06179706
- Sponsor's protocol ID
- Colina-osso
- Status last verified
- Mar 2024
- First submitted
- 30 Nov 2023
- Last updated
- 6 Mar 2024
- 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 11C-choline PET/CT Based Helical Tomotherapy as Innovative Treratment Approach for Bone Metastases in Prostate Cancer Patients.
- ClinicalTrials.gov ID
- NCT06179706
- Acronym / sponsor ID
- Colina-osso
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 27 Oct 2015 (actual)
- Primary completion
- 25 Nov 2015 (actual)
- Study completion
- 25 Nov 2015 (actual)
- First posted
- 22 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 number of metastases may reflect the biological aggressiveness of the tumor and may determine the possibility of performing potential curative interventions such as surgery or high-dose targeted radiotherapy (RT). Until a few years ago, the treatment of choice for metastatic prostate cancer was androgen deprivation (TDA). This treatment was carried out as palliative care in order to postpone the progression of the disease or reduce symptoms. Patients with prostate cancer with a limited number of metastases, similarly to patients suffering from other solid tumors, can be considered as patients with disease that has limited capacity to cause further secondary effects. In this scenario, the primary treatment in patients with carcinoma localized prostate, is characterized by radical prostatectomy, followed by measurement of prostate specific antigen (PSA) during follow-up. After primary prostatectomy, PSA values > 0.2 ng/mL are indicative of disease recurrence, but it is not possible to determine whether the recurrence is local or distant. Furthermore, imaging modalities, such as bone scanning and computed tomography (CT), do not have sufficient sensitivity to detect the presence of metastatic disease in patients with low PSA levels. Positron emission tomography/CT with 11C-choline is able to detect local or distant metastases with a sensitivity and specificity greater than 85% in patients with biochemical disease recurrence. 11C-Choline PET/CT can be a valid tool both for diagnosis and for guiding radiotherapy treatments in these patients for whom it is not possible to obtain a definitive diagnosis with conventional diagnostic procedures. There are currently few studies that have described the use of 11C-choline PET/CT to guide treatment for bone metastases; the limitations of these studies concern the small number of patients and the short follow-up. The aim of this retrospective observational study was to evaluate the efficacy of 11C-choline PET/CT as a guide to the treatment of helical tomotherapy for an innovative therapeutic approach in bone metastases in a population of patients affected by prostate cancer with a limited number of metastasis.
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 suffering from prostate cancer who have undergone primary curative treatment and who have presented biochemical recurrence of the disease.
Key inclusion criteria (2 listed)
- patients diagnosed with less than 3 bone lesions found on C11-Choline PET/CT
- availability of clinical follow-up using serial PSA assays.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 11C-choline PET/CTIn our study we evaluated the efficacy of high-dose RT guided by 11C-Choline PET/CT on bone metastases in prostate cancer patients with a limited number of metastases. | Diagnostic test | – |
Primary outcome
11C-choline PET/CT to the treatment of patients with prostate cancer with a limited number of metastasis.
Time frame: 1 year
Retrospective observational study with 11C-choline PET/CT for the treatment of helical tomotherapy for an innovative therapeutic approach in bone metastases in a population of patients affected by prostate cancer.
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 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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 6 Mar 2024. 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?
11C-choline PET/CT to the treatment of patients with prostate cancer with a limited number of metastasis. (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 Mar 2024.