Prostate CancerPROPETNCT00670527
[18F] Fluorocholine FCH Positron Emission Tomography (PET)/Computed Tomography (CT) for Detection of Prostate Cancer Lymph Nodes Metastases
A study testing [18F] Fluorocholine PET/CT in people with Prostate Cancer, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The objective of this trial is to assess the value of 18F-choline PET/CT for the detection of regional lymph node metastases from prostate cancer. In addition, the investigators want to evaluate whether 18F-choline PET/CT can replace lymphadenectomy for the staging of prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- [18F] Fluorocholine PET/CT
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 205 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2008to Apr 2013
- Phase
- Interventional
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a biopsy confirmed prostate cancer who awaits curative treatment and have
- An elevated level of prostate-specific antigen PSA>10 ng/mL (nanogram per milliliter) or/and
- A Gleason score > 6 or/and
- A TNM staging of T3
Who cannot join
- Patients who withdraw their informed consent.
- Patients who have a bone scan indicates metastatic prostate cancer.
- Patients who have a TNM stage is T4
- In the case we detect a patient having an obvious other major illness e.g. lung cancer, the patient is referred to relevant treatment. Depending on the illness the might be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Mads Hvid Poulsen, MD contact
Steen Walter, MD, DMSci, Professor contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Urology, Odense University Hospital
Odense, 5000
Mads Hvid Poulsen, MD, Mads.Poulsen@ouh.regionsyddanmark.dk
Steen Walter
About this study
Official title: Evaluation of [18F] Fluorocholine PET/CT for Detection of Regional Lymph Node Metastases From Prostate Cancer
The objective of this trial is to assess the value of 18F-choline PET/CT for the detection of regional lymph node metastases from prostate cancer. In addition, the investigators want to evaluate whether 18F-choline PET/CT can replace lymphadenectomy for the staging of prostate cancer.
Read the detailed description
The purpose of this prospective trail is to improve the staging of patients with prostate cancer. The investigators focus on the group of patients with a newly diagnosed prostate cancer, and specifically the ones who have an intermediate and high risk of disseminated prostate cancer.
The aim is to improve staging by replacing the traditional invasive method, the lymphadenectomy, which has a rather low sensitivity by a non-invasive method, 18F-choline PET/CT which has a presumably superior sensitivity.
The treatment of patients with prostate cancer relies on the stage of the disease. Patients with disseminated prostate cancer are incurable and are treated with palliatively. In contrast, patients with localized prostate cancer are offered curative therapy. Hence, the stage of prostate cancer is crucial for the choice of treatment.
The potential benefits are
- The patients avoid the surgical trauma including complications and convalescents period.
- The accuracy of the prostate cancer staging is improved, the potential of which is better survival.
The patients are 18F-choline PET/CT scanned prior to their lymphadenectomy, the results of the 18F-choline PET/CT are blinded for the surgeon. The endpoint of the trail is the comparison of 18F-choline PET/CT and the histopathological investigation of the regional lymph nodes of prostate.
Assuming a prevalence of metastasised prostate cancer of 20% and a true (unknown) sensitivity of FCH PET/CT of 95%, 205 patients are sufficient to show that the sensitivity of the FCH PET/CT is greater than 80% with a power of 80% at significance level 5%. The size of the confidence interval for specificity of FCH PET/CT is expected to become reasonable small. In opposition to lymphadenectomy, FCH PET/CT results may point to metastases in neighbouring regions which gives an additional benefit to FCH PET/CT justifying a test level for sensitivity of 80%."
Accordingly 205 patients will be included over 2½ years. The first patients have been included in January 2008. Interim analyses will be done after 25, 50 and 100 patients.
- Conditions
- Prostate Cancer
- Being tested
- [18F] Fluorocholine PET/CT
- Keywords
- Prostate cancer, [18F] Fluorocholine PET/CT, FCH, lymph node metastasis, staging, sensitivity, specificity, PROPET
- Medical subject headings
- Prostatic Neoplasms, Lymphatic Metastasis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F] Fluorocholine PET/CTProcedure or surgery
The patients fast 6 hours before the [18F]Fluorocholine PET/CT scan. [18F]Fluorocholine will be used as tracer with a dosage of 4 MBq per kg bodyweight. PET/CT imaging will be performed after 15 and 60 after the intravenous injection of the tracer. The patient will receive 2 full body FCH PET/CT. The CT scan is with contrast.
The radiation exposure from the CT scan is 9 mSv and from the PET scan it is 3 mSv, giving a total of 12 mSv, which equals 4 times the yearly background radiation in Denmark.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary target variable "metastasizes to regional lymph nodes" (yes/no) will be used to estimate the diagnostic usefulness of FCH PET/CT in terms of sensitivity, specificity, positive and negative predictive values.
Measured: The [18F] Fluorocholin PET/CT and the lymphadenectomi is done within 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startJan 2008
- Primary completionFeb 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Investigators
- Mads Hvid Poulsen, MD, Principal investigator, Department of Urology, Odense University Hospital, DenmarkUlla Geertsen, MD, Head of Department, Study chair, Department of Urology, Odense University Hospital, DenmarkNiels Svolgaard, MD, Senior Physician, Study chair, Department of Urology, Odense University Hospital, DenmarkSteen Walter, MD, DMSci, Professor, Study chair, Department of Urology, Odense University Hospital, DenmarkKirsten Bouchelouche, MD, DMSci, Study chair, Odense University HospitalMette Høilund-Carlsen, Head Technician, Study chair, Odense University HospitalHenrik Petersen, MD, Senior Physician, Study chair, Odense University HospitalMattias Ögren, Radiochemist, PhD, Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670527
- Sponsor's protocol ID
- PROPET, Project nr. 104.
- Acronym
- PROPET
- Status last verified
- Oct 2012
- First submitted
- 29 Apr 2008
- Last updated
- 8 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Poulsen MH, Bouchelouche K, Hoilund-Carlsen PF, Petersen H, Gerke O, Steffansen SI, Marcussen N, Svolgaard N, Vach W, Geertsen U, Walter S. [18F]fluoromethylcholine (FCH) positron emission tomography/computed tomography (PET/CT) for lymph node staging of prostate cancer: a prospective study of 210 patients. BJU Int. 2012 Dec;110(11):1666-71. doi: 10.1111/j.1464-410X.2012.11150.x. Epub 2012 Apr 23.
PubMed 22520686
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of [18F] Fluorocholine PET/CT for Detection of Regional Lymph Node Metastases From Prostate Cancer
- ClinicalTrials.gov ID
- NCT00670527
- Acronym / sponsor ID
- PROPET / PROPET, Project nr. 104.
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, [18F] Fluorocholine PET/CT, FCH, lymph node metastasis, staging, sensitivity, specificity, PROPET
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- Jan 2008
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 1 May 2008 (estimated)
- 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 objective of this trial is to assess the value of 18F-choline PET/CT for the detection of regional lymph node metastases from prostate cancer. In addition, the investigators want to evaluate whether 18F-choline PET/CT can replace lymphadenectomy for the staging of prostate cancer.
Detailed description
The purpose of this prospective trail is to improve the staging of patients with prostate cancer. The investigators focus on the group of patients with a newly diagnosed prostate cancer, and specifically the ones who have an intermediate and high risk of disseminated prostate cancer.
The aim is to improve staging by replacing the traditional invasive method, the lymphadenectomy, which has a rather low sensitivity by a non-invasive method, 18F-choline PET/CT which has a presumably superior sensitivity.
The treatment of patients with prostate cancer relies on the stage of the disease. Patients with disseminated prostate cancer are incurable and are treated with palliatively. In contrast, patients with localized prostate cancer are offered curative therapy. Hence, the stage of prostate cancer is crucial for the choice of treatment.
The potential benefits are
- The patients avoid the surgical trauma including complications and convalescents period.
- The accuracy of the prostate cancer staging is improved, the potential of which is better survival.
The patients are 18F-choline PET/CT scanned prior to their lymphadenectomy, the results of the 18F-choline PET/CT are blinded for the surgeon. The endpoint of the trail is the comparison of 18F-choline PET/CT and the histopathological investigation of the regional lymph nodes of prostate.
Assuming a prevalence of metastasised prostate cancer of 20% and a true (unknown) sensitivity of FCH PET/CT of 95%, 205 patients are sufficient to show that the sensitivity of the FCH PET/CT is greater than 80% with a power of 80% at significance level 5%. The size of the confidence interval for specificity of FCH PET/CT is expected to become reasonable small. In opposition to lymphadenectomy, FCH PET/CT results may point to metastases in neighbouring regions which gives an additional benefit to FCH PET/CT justifying a test level for sensitivity of 80%."
Accordingly 205 patients will be included over 2½ years. The first patients have been included in January 2008. Interim analyses will be done after 25, 50 and 100 patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a biopsy confirmed prostate cancer who awaits curative treatment and have
- An elevated level of prostate-specific antigen PSA>10 ng/mL (nanogram per milliliter) or/and
- A Gleason score > 6 or/and
- A TNM staging of T3
Key exclusion criteria (4 listed)
- Patients who withdraw their informed consent.
- Patients who have a bone scan indicates metastatic prostate cancer.
- Patients who have a TNM stage is T4
- In the case we detect a patient having an obvious other major illness e.g. lung cancer, the patient is referred to relevant treatment. Depending on the illness the might be excluded from the study.
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 |
|---|---|---|
| [18F] Fluorocholine PET/CTThe patients fast 6 hours before the [18F]Fluorocholine PET/CT scan. [18F]Fluorocholine will be used as tracer with a dosage of 4 MBq per kg bodyweight. PET/CT imaging will be performed after 15 and 60 after the intravenous injection of the tracer. The patient will receive 2 full body FCH PET/CT. The CT scan is with contrast. The radiation exposure from the CT scan is 9 mSv and from the PET scan it is 3 mSv, giving a total of 12 mSv, which equals 4 times the yearly background radiation in Denmark. | Procedure or surgery | – |
Primary outcome
The primary target variable "metastasizes to regional lymph nodes" (yes/no) will be used to estimate the diagnostic usefulness of FCH PET/CT in terms of sensitivity, specificity, positive and negative predictive values.
Time frame: The [18F] Fluorocholin PET/CT and the lymphadenectomi is done within 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2012.
- Derived from this study: PubMed 22520686Poulsen MH, Bouchelouche K, Hoilund-Carlsen PF, Petersen H, Gerke O, Steffansen SI, Marcussen N, Svolgaard N, Vach W, Geertsen U, Walter S. [18F]fluoromethylcholine (FCH) positron emission tomography/computed tomography (PET/CT) for lymph node staging of prostate cancer: a prospective study of 210 patients. BJU Int. 2012 Dec;110(11):1666-71. doi: 10.1111/j.1464-410X.2012.11150.x. Epub 2012 Apr 23.
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.
Mads Hvid Poulsen, MD contact
Steen Walter, MD, DMSci, Professor contact
Mads Hvid Poulsen, MD principal investigator
Department of Urology, Odense University Hospital, Denmark
Ulla Geertsen, MD, Head of Department study chair
Department of Urology, Odense University Hospital, Denmark
Niels Svolgaard, MD, Senior Physician study chair
Department of Urology, Odense University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F] Fluorocholine PET/CT in people with Prostate Cancer, run by Odense University Hospital at 1 site in Denmark.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Oct 2012. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mads Hvid Poulsen, MD (Mads.Poulsen@ouh.regionsyddanmark.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary target variable "metastasizes to regional lymph nodes" (yes/no) will be used to estimate the diagnostic usefulness of FCH PET/CT in terms of sensitivity, specificity, positive and negative predictive values. (time frame: The [18F] Fluorocholin PET/CT and the lymphadenectomi is done within 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00670527, which also lists 1 linked publication.
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 8 Oct 2012.