Prostate CancerNCT02232672
Choline PET/CT vs. MeAIB PET/CT in Prostate Cancer
A study testing Choline PET/CT and MeAIB PET/CT in people with Prostate Cancer, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Prostate cancer is currently the leading newly diagnosed cancer in the industrialized world. Treatment of prostate cancer is highly dependent on the stage of the disease. Current methods for staging of bone metastases are known to be inaccurate. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Choline PET/CT and MeAIB PET/CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2016to Aug 2017
- 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
- Newly diagnosed, histologically verified PCa and
- Written consent and
- Planned extended lymph node dissection and
- PSA ≥ 20 ng/mL and/or
- Gleason score > 6 and/or
- cT-stage ≥ cT2c
Who cannot join
- Withdrawal of consent or
- Other active malign disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Choline PET/CT vs. MeAIB PET/CT. Better Detection of Bone and Lymph Node Metastases in Prostate Cancer Patients, PROSTAGE III
Prostate cancer is currently the leading newly diagnosed cancer in the industrialized world. Treatment of prostate cancer is highly dependent on the stage of the disease. Current methods for staging of bone metastases are known to be inaccurate. Staging of lymph nodes requires surgery associated with risk of bleeding etc. Prior studies from our department suggest that PET/CT is useful in staging of bone metastases in patients with prostate cancer. The aim of this study is to compare the usefulness of MeAIB PET/CT with current methods for the staging of bone and lymph node metastases in patients with newly diagnosed prostate cancer.
Better initial staging will result in better treatment of the individual patient. If we are able to develop a more accurate and non-invasive method of staging patients with undetected metastases on current staging will be spared of the side-effects associated with current treatment and staging- impotence, incontinence, radiation damage, bleeding, infection etc.
Read the detailed description
- Introduction. Cancer of the prostate (PCa) is currently the leading newly diagnosed cancer and the second most common cause of cancer deaths among men in the industrialized world . In Denmark alone more than 4000 men are yearly diagnosed with PCa . As PCa primarily affects elderly patients, one can assume that PCa will become one of the most important medical issues in the developed world due to the already high incidence combined with a growing population of elderly men. The aetiology of the disease is not well understood. In its most common form PCa evolves from the glandular tissue of the prostate. Metastatic spread will most commonly happen as lymphogenous spread to the regional lymph nodes or as haematogenous spread to the red bone marrow . Intended curative treatment of PCa is associated with considerable side effects, in particular incontinence, impotence and radiation damage to the surrounding tissues. Furthermore, over 30% of patients with organ-confined disease, which was treated with radical prostatectomy, will have biochemical relapse within 10 years . Relapse may be due to local recurrent disease suggesting poor surgical quality or poor initial staging with undetected metastases at the time of treatment. At diagnosis patients are stratified as having low, intermediary or high risk of dissieminatio according to D'Amico . Patients with intermediate or high risk of dissemination will be examined further with whole-body bone scintigraphy (WBS) and pelvic lymph node dissection (PLND).
- Background. 2.1. Current staging and limitations. WBS has been the examination of choice for evaluation of potential dissemination to bone. WBS utilizes 99mTc-labeled methylene diphosphonate (99mTc-MDP) that binds to the bone matrix formed by the osteoblasts. Gamma cameras detect the γ-radiation emitted by the decaying tracer thereby creating a 2-dimentional image depicting local osteoblast activity . Several limitations apply to the use of WBS in staging of patients with PCa. Sensitivity has reported as low as 39% in lesion-based analysis in patients with a low number of lesions . This combines with a low sensitivity due to many equivocal lesions caused by other bone pathology than metastasis. Sensitivity and specificity is improved by the use of single-photon emission computed tomography (SPECT), where the same tracer as with WBS is used to generate a three-dimensional image using a rotating gamma camera. This method also gives better anatomical information on the exact position of a potential metastasis. The examination of choice for the evaluation of potential metastases to lymph nodes is extended PLND . This procedure is done either prior to radiotherapy or during prostatectomy in patients with intermediate or high risk of dissemination. The optimal extent of the dissection is debated. The extended PLND performed at our institution includes the nodes in the obturator fossa, the nodes over the external iliac artery and vein, the nodes around the internal iliac artery and the nodes along the common iliac artery up to the crossing of the ureter. This dissection is assumed to include approximately 75% of lymph nodes known to harbor primary prostatic lymph node metastases . Extended PLND is surgically demanding with risk of lymphocele formation, infectious complications and severe bleeding due the lymph nodes' close proximity to the large vessels in the pelvis. All in all extended PLND is perhaps the best option for lymph node staging of PCa but it cannot be considered as optimal due to the above-mentioned issues. 2.2 Positron Emission Tomography (PET). Positron Emission Tomography combined with Computerized Tomography (PET/CT) is a well-established tool in diagnosing and staging of several types of cancer . PET is an imaging technique where pairs of gamma rays emitted by positron-emitting radionuclide tracer are detected, producing a three-dimensional image of tracer concentration based on the amount of gamma rays emitted. The radioactive tracer is coupled to a biologically active molecule depending on the organ or metabolic process of interest . These images can then be fused with CT to create a combined functional and high-resolution anatomical image. Several tracers have been developed for use in cancer diagnostics and staging. As of now, PET/CT has no generally accepted role in the diagnosing or staging of PCa neither in Europe nor in the US . 2.2.1 Choline. Choline is a precursor for phosphatidylcholine, a phospholipid that is integrated in the cell membrane making it a marker for cell membrane turnover and metabolism . 11C-Choline was first used as a PET tracer in 1997 . Since then many studies have been performed with 11C-Choline and later 18F-Choline (FCH) having approximately the same properties as 11C-Choline, but with a longer half-life (110 min vs. 20 min) making it more versatile in every-day use. A recent study from our department tested the use of FCH-PET/CT in detecting lymph node metastasis in 210 patients with PCa . The study concluded that FCH-PET/CT was not ideally suited for lymph node staging but could give additional information about bone metastasis. Several other investigators have also implied this , . A likely reason for the better detection of metastasis to the bone is that bone metastasis in an early stage is actually bone-marrow metastases rather than bone matrix metastasis and that it most likely that bone-marrow metastases proceed to bone matrix metastases. These will not be detectable by WBS (and probably not by CT and MRI either). Larger prospective series on the use of FCH-PET/CT for imaging of bone metastasis in PCa-patients have not yet been produced. 2.2.2 MeAIB. α-(N-methyl-11C)-methylaminobutyric acid (MeAIB) is an amino acid analog that concentrates into cells only via the System A amino acid transport system, which has been shown to be highly upregulated in malignant cells making it a potential target for oncological imaging . The tracer has been developed by our local chief radiochemist and studies on biodistribution and dosimetry conclude that MeAIB is a tracer usable in humans with radiation doses lower than other used PET-tracers , . Clinical studies on the use of MeAIB-PET/CT in oncology are sparse , . The use of MeAIB-PET/CT in PCa has not been investigated. Unpublished data suggests that MeAIB could prove useful in diagnosing PCa because of a high uptake in prostatic tumors . Due to the short half-life of 11C (20 min.) an onsite cyclotron is required for performing the study, and thus this is possible in Odense.
- Trial objective. To evaluate the diagnostic value of MeAIB-PET/CT in detecting bone and lymph node metastases in 30 patients with newly diagnosed PCa
- Method. Patients included will have a choline-PET/CT perfomed as part of another project. In addition a MeAIB-PET/CT will be performed. The MeAIB PET/CT is performed with a single acquisition 1 hour after injection of tracer. All scans are performed in random order within three weeks and the images interpreted by a specialist in nuclear medicine and a specialist in radiology. Images are interpreted based on visual evaluation with supplementary measurements of SUV. Activity in lymph nodes will be recorded according to their location - external iliac vein, obturator fossa and internal iliac artery and vein.
- Conditions
- Prostate Cancer
- Being tested
- Choline PET/CT and MeAIB PET/CT
- Keywords
- Prostate Cancer, Staging, 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.
Choline PET/CT and MeAIB PET/CTDevice
Choline PET/CT and MeAIB PET/CT
| Study group | Role | What they receive |
|---|---|---|
| MeAIB PET/CT | Experimental | Choline PET/CT and MeAIB PET/CT Receives: Device: Choline PET/CT and MeAIB PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metastases to bone (yes/no) Metastases to lymph nodes (yes/no)
Measured: 1 day (At the time of scan interpretation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startNov 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mike Allan Mortensen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232672
- Sponsor's protocol ID
- MAM_PROSTAGE3
- Status last verified
- Oct 2017
- First submitted
- 3 Sep 2014
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choline PET/CT vs. MeAIB PET/CT. Better Detection of Bone and Lymph Node Metastases in Prostate Cancer Patients, PROSTAGE III
- ClinicalTrials.gov ID
- NCT02232672
- Acronym / sponsor ID
- MAM_PROSTAGE3
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Staging, PET/CT
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 5 Sep 2014 (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.
Prostate cancer is currently the leading newly diagnosed cancer in the industrialized world. Treatment of prostate cancer is highly dependent on the stage of the disease. Current methods for staging of bone metastases are known to be inaccurate. Staging of lymph nodes requires surgery associated with risk of bleeding etc. Prior studies from our department suggest that PET/CT is useful in staging of bone metastases in patients with prostate cancer. The aim of this study is to compare the usefulness of MeAIB PET/CT with current methods for the staging of bone and lymph node metastases in patients with newly diagnosed prostate cancer.
Better initial staging will result in better treatment of the individual patient. If we are able to develop a more accurate and non-invasive method of staging patients with undetected metastases on current staging will be spared of the side-effects associated with current treatment and staging- impotence, incontinence, radiation damage, bleeding, infection etc.
Detailed description
- Introduction. Cancer of the prostate (PCa) is currently the leading newly diagnosed cancer and the second most common cause of cancer deaths among men in the industrialized world . In Denmark alone more than 4000 men are yearly diagnosed with PCa . As PCa primarily affects elderly patients, one can assume that PCa will become one of the most important medical issues in the developed world due to the already high incidence combined with a growing population of elderly men. The aetiology of the disease is not well understood. In its most common form PCa evolves from the glandular tissue of the prostate. Metastatic spread will most commonly happen as lymphogenous spread to the regional lymph nodes or as haematogenous spread to the red bone marrow . Intended curative treatment of PCa is associated with considerable side effects, in particular incontinence, impotence and radiation damage to the surrounding tissues. Furthermore, over 30% of patients with organ-confined disease, which was treated with radical prostatectomy, will have biochemical relapse within 10 years . Relapse may be due to local recurrent disease suggesting poor surgical quality or poor initial staging with undetected metastases at the time of treatment. At diagnosis patients are stratified as having low, intermediary or high risk of dissieminatio according to D'Amico . Patients with intermediate or high risk of dissemination will be examined further with whole-body bone scintigraphy (WBS) and pelvic lymph node dissection (PLND).
- Background. 2.1. Current staging and limitations. WBS has been the examination of choice for evaluation of potential dissemination to bone. WBS utilizes 99mTc-labeled methylene diphosphonate (99mTc-MDP) that binds to the bone matrix formed by the osteoblasts. Gamma cameras detect the γ-radiation emitted by the decaying tracer thereby creating a 2-dimentional image depicting local osteoblast activity . Several limitations apply to the use of WBS in staging of patients with PCa. Sensitivity has reported as low as 39% in lesion-based analysis in patients with a low number of lesions . This combines with a low sensitivity due to many equivocal lesions caused by other bone pathology than metastasis. Sensitivity and specificity is improved by the use of single-photon emission computed tomography (SPECT), where the same tracer as with WBS is used to generate a three-dimensional image using a rotating gamma camera. This method also gives better anatomical information on the exact position of a potential metastasis. The examination of choice for the evaluation of potential metastases to lymph nodes is extended PLND . This procedure is done either prior to radiotherapy or during prostatectomy in patients with intermediate or high risk of dissemination. The optimal extent of the dissection is debated. The extended PLND performed at our institution includes the nodes in the obturator fossa, the nodes over the external iliac artery and vein, the nodes around the internal iliac artery and the nodes along the common iliac artery up to the crossing of the ureter. This dissection is assumed to include approximately 75% of lymph nodes known to harbor primary prostatic lymph node metastases . Extended PLND is surgically demanding with risk of lymphocele formation, infectious complications and severe bleeding due the lymph nodes' close proximity to the large vessels in the pelvis. All in all extended PLND is perhaps the best option for lymph node staging of PCa but it cannot be considered as optimal due to the above-mentioned issues. 2.2 Positron Emission Tomography (PET). Positron Emission Tomography combined with Computerized Tomography (PET/CT) is a well-established tool in diagnosing and staging of several types of cancer . PET is an imaging technique where pairs of gamma rays emitted by positron-emitting radionuclide tracer are detected, producing a three-dimensional image of tracer concentration based on the amount of gamma rays emitted. The radioactive tracer is coupled to a biologically active molecule depending on the organ or metabolic process of interest . These images can then be fused with CT to create a combined functional and high-resolution anatomical image. Several tracers have been developed for use in cancer diagnostics and staging. As of now, PET/CT has no generally accepted role in the diagnosing or staging of PCa neither in Europe nor in the US . 2.2.1 Choline. Choline is a precursor for phosphatidylcholine, a phospholipid that is integrated in the cell membrane making it a marker for cell membrane turnover and metabolism . 11C-Choline was first used as a PET tracer in 1997 . Since then many studies have been performed with 11C-Choline and later 18F-Choline (FCH) having approximately the same properties as 11C-Choline, but with a longer half-life (110 min vs. 20 min) making it more versatile in every-day use. A recent study from our department tested the use of FCH-PET/CT in detecting lymph node metastasis in 210 patients with PCa . The study concluded that FCH-PET/CT was not ideally suited for lymph node staging but could give additional information about bone metastasis. Several other investigators have also implied this , . A likely reason for the better detection of metastasis to the bone is that bone metastasis in an early stage is actually bone-marrow metastases rather than bone matrix metastasis and that it most likely that bone-marrow metastases proceed to bone matrix metastases. These will not be detectable by WBS (and probably not by CT and MRI either). Larger prospective series on the use of FCH-PET/CT for imaging of bone metastasis in PCa-patients have not yet been produced. 2.2.2 MeAIB. α-(N-methyl-11C)-methylaminobutyric acid (MeAIB) is an amino acid analog that concentrates into cells only via the System A amino acid transport system, which has been shown to be highly upregulated in malignant cells making it a potential target for oncological imaging . The tracer has been developed by our local chief radiochemist and studies on biodistribution and dosimetry conclude that MeAIB is a tracer usable in humans with radiation doses lower than other used PET-tracers , . Clinical studies on the use of MeAIB-PET/CT in oncology are sparse , . The use of MeAIB-PET/CT in PCa has not been investigated. Unpublished data suggests that MeAIB could prove useful in diagnosing PCa because of a high uptake in prostatic tumors . Due to the short half-life of 11C (20 min.) an onsite cyclotron is required for performing the study, and thus this is possible in Odense.
- Trial objective. To evaluate the diagnostic value of MeAIB-PET/CT in detecting bone and lymph node metastases in 30 patients with newly diagnosed PCa
- Method. Patients included will have a choline-PET/CT perfomed as part of another project. In addition a MeAIB-PET/CT will be performed. The MeAIB PET/CT is performed with a single acquisition 1 hour after injection of tracer. All scans are performed in random order within three weeks and the images interpreted by a specialist in nuclear medicine and a specialist in radiology. Images are interpreted based on visual evaluation with supplementary measurements of SUV. Activity in lymph nodes will be recorded according to their location - external iliac vein, obturator fossa and internal iliac artery and vein.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MeAIB PET/CT | Experimental | Device: Choline PET/CT and MeAIB PET/CTCholine PET/CT and MeAIB PET/CT |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Newly diagnosed, histologically verified PCa and
- Written consent and
- Planned extended lymph node dissection and
- PSA ≥ 20 ng/mL and/or
- Gleason score > 6 and/or
Key exclusion criteria (2 listed)
- Withdrawal of consent or
- Other active malign disease
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 |
|---|---|---|
| Choline PET/CT and MeAIB PET/CTCholine PET/CT and MeAIB PET/CT | Device | MeAIB PET/CT |
Primary outcome
Metastases to bone (yes/no) Metastases to lymph nodes (yes/no)
Time frame: 1 day (At the time of scan interpretation)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
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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?
A study testing Choline PET/CT and MeAIB 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 6 inclusion and 2 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: withdrawn, as of the sponsor's last update on 13 Oct 2017. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Metastases to bone (yes/no) Metastases to lymph nodes (yes/no) (time frame: 1 day (At the time of scan interpretation)). 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 Oct 2017.