Determination of the Diagnostic Detection Rate of Axumin (Fluciclovine) Digital PET/CT, Post-prostatectomy
NCT ID: NCT04234399
Last Updated: 2024-01-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Total Enrollment
22 participants
Study Classification
OBSERVATIONAL
Study Start Date
2020-03-01
Study Completion Date
2024-01-01
Brief Summary
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Fluciclovine F18 (Axumin) has been demonstrated to provide good delineation of recurrence of prostate cancer after definitive therapies. Fluciclovine in conjunction with the high-resolution digital Vereos (Phillips) PET-CT scanner may detect low volume recurrence in the prostatectomy bed or metastatic site (s).
20-40 % of men will suffer a biochemical recurrence of their prostate cancer after radical prostatectomy, depending on their final pathological staging, defined as a rising PSA \> 0.2 ng/ml.
The ability to more accurately diagnose local recurrence (i.e. pelvis) or oligometastasis may lead to the opportunity of precise therapy of these sites with more durable cancer responses, less morbidity and potential cure in selective men after Radical Prostatectomy.
The ability to diagnose widespread metastatic Prostate Cancer after Radical Prostatectomy, or disease that is inaccessible to local selective therapies would spare these men the cost and morbidity of inappropriate therapy.
The diagnosis of true stage D0 Prostate Cancer (No objective evidence of metastases) in men after Radical Prostatectomy would yield improved overall and disease specific survival if Androgen Deprivation Therapy was initiated at its earliest stage. This would also obviate the need for inappropriate local therapies (i.e. pelvic radiotherapy).
The aim is to compare the detection rate of standard of care (CT Pelvis/Abdomen, MR Pelvis, Bone Scan) with Fluciclovine PET/CT performed on the Vereos Philips Scanner. The study aims to compare the performance of Digital (high resolution) PET to CT/MRI/Bone scan rather than analog (lower resolution) PET. Prior studies have tested analog PET compared to other modalities. One could make an inference that if our study's Digital PET performs better than the performance of Analog PET in those studies, then Digital PET should have a better detection rate than Analog PET. However, investigators are not making a direct comparison between digital and Analog in our comparison.
20-40 % of men will suffer a biochemical recurrence of their prostate cancer after radical prostatectomy, depending on their final pathological staging, defined as a rising PSA \> 0.2 ng/ml.
The ability to more accurately diagnose local recurrence (i.e. pelvis) or oligometastasis may lead to the opportunity of precise therapy of these sites with more durable cancer responses, less morbidity and potential cure in selective men after Radical Prostatectomy.
The ability to diagnose widespread metastatic Prostate Cancer after Radical Prostatectomy, or disease that is inaccessible to local selective therapies would spare these men the cost and morbidity of inappropriate therapy.
The diagnosis of true stage D0 Prostate Cancer (No objective evidence of metastases) in men after Radical Prostatectomy would yield improved overall and disease specific survival if Androgen Deprivation Therapy was initiated at its earliest stage. This would also obviate the need for inappropriate local therapies (i.e. pelvic radiotherapy).
The aim is to compare the detection rate of standard of care (CT Pelvis/Abdomen, MR Pelvis, Bone Scan) with Fluciclovine PET/CT performed on the Vereos Philips Scanner. The study aims to compare the performance of Digital (high resolution) PET to CT/MRI/Bone scan rather than analog (lower resolution) PET. Prior studies have tested analog PET compared to other modalities. One could make an inference that if our study's Digital PET performs better than the performance of Analog PET in those studies, then Digital PET should have a better detection rate than Analog PET. However, investigators are not making a direct comparison between digital and Analog in our comparison.
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Detailed Description
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Aim:
Compare the detection rate of standard of care (CT Pelvis/Abdomen, MR Pelvis, Bone Scan) with Fluciclovine PET/CT performed on the Vereos Philips Scanner. The study aims to compare the performance of Digital (high resolution) PET to CT/MRI/Bone scan rather than analog (lower resolution) PET. This was reported in Michopoulou S, O'Shaughnessy E, Thomson K, Guy MJ. Discovery Molecular Imaging Digital Ready PET/CT performance evaluation according to the NEMA NU2-2012 standard. Nucl Med Commun. 2018 Nov 27; doi:10.1097/MNM.0000000000000962. Prior studies have tested analog PET compared to other modalities. One could make an inference that if our study's Digital PET performs better than the performance of Analog PET in those studies, then Digital PET should have a better detection rate than Analog PET. However, investigators are not making a direct comparison between digital and Analog in our comparison.
Background:
Fluciclovine F18 (Fluciclovine) has been demonstrated to provide good delineation of recurrence of prostate cancer after definitive therapies (Odewole OA et al 2016). Fluciclovine in conjunction with the high-resolution digital Vereos (Phillips) PET-CT scanner may detect low volume recurrence in the prostatectomy bed or metastatic site (s).
20-40 % of men will suffer a biochemical recurrence of their prostate cancer after radical prostatectomy, depending on their final pathological staging, defined as a rising PSA \> 0.2 ng/ml.
The ability to more accurately diagnose local recurrence (i.e. pelvis) or oligometastasis may lead to the opportunity of precise therapy of these sites with more durable cancer responses, less morbidity and potential cure in selective men after Radical Prostatectomy.
The ability to diagnose widespread metastatic Prostate Cancer after Radical Prostatectomy, or disease that is inaccessible to local selective therapies would spare these men the cost and morbidity of inappropriate therapy.
The diagnosis of true stage D0 Prostate Cancer (No objective evidence of metastases) in men after Radical Prostatectomy would yield improved overall and disease specific survival if Androgen Deprivation Therapy was initiated at its earliest stage. This would also obviate the need for inappropriate local therapies (i.e. pelvic radiotherapy).
Preliminary Studies:
The safety, efficacy, reproducibility, and reliability of Fluciclovine was initially evaluated by the Emory group in men with suspected recurrence of prostate cancer based on rising PSA levels following radical prostatectomy and/or radiotherapy. Fluciclovine's safety, detection rate, and diagnostic performance was further validated in a multi-site data aggregation study using data from Emory, Noway, and Italy.
The performance of Fluciclovine seems to be affected by degree of PSA elevation. Statistically significant difference in performance compared to CT was found at PSA levels \>1 ng/ml. However, at a PSA level of \<1 ng/ml, no statistically significant difference was found by Odewole et al. These findings were independent of PSA doubling time and Gleason Score.
The Bologna study evaluated the concordance between Fluciclovine and C11 Choline scans in patients with median PSA value of 1.44 ng/ml (interquartile range = 0.78 to 2.8 ng/ml).5 The accuracy of Fluciclovine was 38% vs 32% for C11 Choline. In a subsequent Emory study which studied Fluciclovine without a correlative imaging test, Fluciclovine scan detected recurrence in 72% (18/25) of patients with PSA of \<1 ng/ml. However, there was no reconciliation of false positive examinations, as all abnormal radiotracer uptake were deemed a true positive. Performance of Fluciclovine was again noted to improve with increasing PSA levels, at 83% (5/6) for PSA of 1-\<2 ng/ml and 100% (11/11) for PSA\>= 2 ng/ml.
Rationale:
A Fluciclovine scan can detect and localize recurrent prostate cancer. Fluciclovine is an FDA-approved diagnostic imaging agent, also known as a "tracer," which may help determine if and where the prostate cancer has recurred.
Procedures:
Fluciclovine is used as a tracer for a PET/CT scan. Patients will need to prepare for the Fluciclovine (fluciclovine F 18) injection and scan. They will need avoid any significant exercise for at least a full 24 hours prior to Fluciclovine PET/CT scan and not eat or drink for at least 4 hours prior to PET/CT scan (other than small amounts of water for taking medications).
With respect to determining if a finding is true positive, investigators will follow the following process. The research PET scan of each patient and SOC imaging will be read by radiologists blinded to the results of the other test. The results of both will then be reviewed by PI for concordance. If the research PET scan finds sites of disease that were not identified on SOC imaging, the case will be brought to Interdisciplinary UVMMC Genitourinary tumor board. Depending on the site of disease and presence of other concordant sites of metastatic disease between scans, it may have no impact on the SOC treatment. If it is deemed by the UVMMC Genitourinary Tumor Board that it will have a meaningful impact on treatment decisions and the detected lesion is accessible to be safely sampled, the patient will be approached by their treating physician to discuss the discordant findings, their significance, and the rationale behind a biopsy and its impact on their care.
The sampling will then be performed a part of standard-of-care work-up, given that these patients would have been eligible for Fluciclovine PET imaging in this setting, per FDA label. Given the low PSA range of our target population in this study, the likelihood that these lesions would be amenable to sampling using conventional image guidance is low. Therefore, in cases where the research scan finds additional disease that would alter therapy, the decision of whether to act on it will be based on the overall clinical scenario of each patient, and will be decided by the treating team with the support of the UVMMC Genitourinary Tumor Board.
Compare the detection rate of standard of care (CT Pelvis/Abdomen, MR Pelvis, Bone Scan) with Fluciclovine PET/CT performed on the Vereos Philips Scanner. The study aims to compare the performance of Digital (high resolution) PET to CT/MRI/Bone scan rather than analog (lower resolution) PET. This was reported in Michopoulou S, O'Shaughnessy E, Thomson K, Guy MJ. Discovery Molecular Imaging Digital Ready PET/CT performance evaluation according to the NEMA NU2-2012 standard. Nucl Med Commun. 2018 Nov 27; doi:10.1097/MNM.0000000000000962. Prior studies have tested analog PET compared to other modalities. One could make an inference that if our study's Digital PET performs better than the performance of Analog PET in those studies, then Digital PET should have a better detection rate than Analog PET. However, investigators are not making a direct comparison between digital and Analog in our comparison.
Background:
Fluciclovine F18 (Fluciclovine) has been demonstrated to provide good delineation of recurrence of prostate cancer after definitive therapies (Odewole OA et al 2016). Fluciclovine in conjunction with the high-resolution digital Vereos (Phillips) PET-CT scanner may detect low volume recurrence in the prostatectomy bed or metastatic site (s).
20-40 % of men will suffer a biochemical recurrence of their prostate cancer after radical prostatectomy, depending on their final pathological staging, defined as a rising PSA \> 0.2 ng/ml.
The ability to more accurately diagnose local recurrence (i.e. pelvis) or oligometastasis may lead to the opportunity of precise therapy of these sites with more durable cancer responses, less morbidity and potential cure in selective men after Radical Prostatectomy.
The ability to diagnose widespread metastatic Prostate Cancer after Radical Prostatectomy, or disease that is inaccessible to local selective therapies would spare these men the cost and morbidity of inappropriate therapy.
The diagnosis of true stage D0 Prostate Cancer (No objective evidence of metastases) in men after Radical Prostatectomy would yield improved overall and disease specific survival if Androgen Deprivation Therapy was initiated at its earliest stage. This would also obviate the need for inappropriate local therapies (i.e. pelvic radiotherapy).
Preliminary Studies:
The safety, efficacy, reproducibility, and reliability of Fluciclovine was initially evaluated by the Emory group in men with suspected recurrence of prostate cancer based on rising PSA levels following radical prostatectomy and/or radiotherapy. Fluciclovine's safety, detection rate, and diagnostic performance was further validated in a multi-site data aggregation study using data from Emory, Noway, and Italy.
The performance of Fluciclovine seems to be affected by degree of PSA elevation. Statistically significant difference in performance compared to CT was found at PSA levels \>1 ng/ml. However, at a PSA level of \<1 ng/ml, no statistically significant difference was found by Odewole et al. These findings were independent of PSA doubling time and Gleason Score.
The Bologna study evaluated the concordance between Fluciclovine and C11 Choline scans in patients with median PSA value of 1.44 ng/ml (interquartile range = 0.78 to 2.8 ng/ml).5 The accuracy of Fluciclovine was 38% vs 32% for C11 Choline. In a subsequent Emory study which studied Fluciclovine without a correlative imaging test, Fluciclovine scan detected recurrence in 72% (18/25) of patients with PSA of \<1 ng/ml. However, there was no reconciliation of false positive examinations, as all abnormal radiotracer uptake were deemed a true positive. Performance of Fluciclovine was again noted to improve with increasing PSA levels, at 83% (5/6) for PSA of 1-\<2 ng/ml and 100% (11/11) for PSA\>= 2 ng/ml.
Rationale:
A Fluciclovine scan can detect and localize recurrent prostate cancer. Fluciclovine is an FDA-approved diagnostic imaging agent, also known as a "tracer," which may help determine if and where the prostate cancer has recurred.
Procedures:
Fluciclovine is used as a tracer for a PET/CT scan. Patients will need to prepare for the Fluciclovine (fluciclovine F 18) injection and scan. They will need avoid any significant exercise for at least a full 24 hours prior to Fluciclovine PET/CT scan and not eat or drink for at least 4 hours prior to PET/CT scan (other than small amounts of water for taking medications).
With respect to determining if a finding is true positive, investigators will follow the following process. The research PET scan of each patient and SOC imaging will be read by radiologists blinded to the results of the other test. The results of both will then be reviewed by PI for concordance. If the research PET scan finds sites of disease that were not identified on SOC imaging, the case will be brought to Interdisciplinary UVMMC Genitourinary tumor board. Depending on the site of disease and presence of other concordant sites of metastatic disease between scans, it may have no impact on the SOC treatment. If it is deemed by the UVMMC Genitourinary Tumor Board that it will have a meaningful impact on treatment decisions and the detected lesion is accessible to be safely sampled, the patient will be approached by their treating physician to discuss the discordant findings, their significance, and the rationale behind a biopsy and its impact on their care.
The sampling will then be performed a part of standard-of-care work-up, given that these patients would have been eligible for Fluciclovine PET imaging in this setting, per FDA label. Given the low PSA range of our target population in this study, the likelihood that these lesions would be amenable to sampling using conventional image guidance is low. Therefore, in cases where the research scan finds additional disease that would alter therapy, the decision of whether to act on it will be based on the overall clinical scenario of each patient, and will be decided by the treating team with the support of the UVMMC Genitourinary Tumor Board.
Conditions
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Prostatic Neoplasm
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Study Groups
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Group
All patients receiving SOC imaging and Axumin PET scans.
Fluciclovine PET/CT using a digital PET/CT
Intervention Type
DIAGNOSTIC_TEST
Fluciclovine is a radiotracer that will be used in conjunction with the high resolution digital Vereos PET/CT scanner.
Interventions
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Fluciclovine PET/CT using a digital PET/CT
Fluciclovine is a radiotracer that will be used in conjunction with the high resolution digital Vereos PET/CT scanner.
Intervention Type
DIAGNOSTIC_TEST
Eligibility Criteria
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Inclusion Criteria
1. Prostatectomy patients with previously undetectable PSA and subsequent biochemical recurrence defined by PSA between 0.2 ng/ml and 1.0 ng/ml within 90 days prior to Fluciclovine scan
2. Age \>40
3. Ability to provide informed consent
2. Age \>40
3. Ability to provide informed consent
Exclusion Criteria
1. History of allergic reaction to Fluciclovine
2. Anti Androgen treatment in the 6 months prior to enrollment
3. Any patient whose body habitus, as determined by radiology personnel, will effectively inhibit the ability to obtain PET/CT imaging or will interfere with the images so as to make them clinically uninterpretable.
2. Anti Androgen treatment in the 6 months prior to enrollment
3. Any patient whose body habitus, as determined by radiology personnel, will effectively inhibit the ability to obtain PET/CT imaging or will interfere with the images so as to make them clinically uninterpretable.
Minimum Eligible Age
40 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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University of Vermont
OTHER
Sponsor Role
lead
Responsible Party
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Dmitriy Akselrod, MD
Assistant Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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UVM Medical Center
Burlington, Vermont, United States
Site Status
Countries
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United States
References
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Schuster DM, Nieh PT, Jani AB, Amzat R, Bowman FD, Halkar RK, Master VA, Nye JA, Odewole OA, Osunkoya AO, Savir-Baruch B, Alaei-Taleghani P, Goodman MM. Anti-3-[(18)F]FACBC positron emission tomography-computerized tomography and (111)In-capromab pendetide single photon emission computerized tomography-computerized tomography for recurrent prostate carcinoma: results of a prospective clinical trial. J Urol. 2014 May;191(5):1446-53. doi: 10.1016/j.juro.2013.10.065. Epub 2013 Oct 19.
Reference Type
BACKGROUND
Odewole OA, Oyenuga OA, Tade F, Savir-Baruch B, Nieh PT, Master V, Chen Z, Wang X, Jani AB, Bellamy LM, Halkar RK, Goodman MM, Schuster DM. Reproducibility and reliability of anti-3-[(1)(8)F]FACBC uptake measurements in background structures and malignant lesions on follow-up PET-CT in prostate carcinoma: an exploratory analysis. Mol Imaging Biol. 2015 Apr;17(2):277-83. doi: 10.1007/s11307-014-0797-1.
Reference Type
BACKGROUND
Schuster DM, Savir-Baruch B, Nieh PT, Master VA, Halkar RK, Rossi PJ, Lewis MM, Nye JA, Yu W, Bowman FD, Goodman MM. Detection of recurrent prostate carcinoma with anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid PET/CT and 111In-capromab pendetide SPECT/CT. Radiology. 2011 Jun;259(3):852-61. doi: 10.1148/radiol.11102023. Epub 2011 Apr 14.
Reference Type
BACKGROUND
Odewole OA, Tade FI, Nieh PT, Savir-Baruch B, Jani AB, Master VA, Rossi PJ, Halkar RK, Osunkoya AO, Akin-Akintayo O, Zhang C, Chen Z, Goodman MM, Schuster DM. Recurrent prostate cancer detection with anti-3-[(18)F]FACBC PET/CT: comparison with CT. Eur J Nucl Med Mol Imaging. 2016 Sep;43(10):1773-83. doi: 10.1007/s00259-016-3383-8. Epub 2016 Apr 18.
Reference Type
BACKGROUND
Nanni C, Zanoni L, Pultrone C, Schiavina R, Brunocilla E, Lodi F, Malizia C, Ferrari M, Rigatti P, Fonti C, Martorana G, Fanti S. (18)F-FACBC (anti1-amino-3-(18)F-fluorocyclobutane-1-carboxylic acid) versus (11)C-choline PET/CT in prostate cancer relapse: results of a prospective trial. Eur J Nucl Med Mol Imaging. 2016 Aug;43(9):1601-10. doi: 10.1007/s00259-016-3329-1. Epub 2016 Mar 10.
Reference Type
BACKGROUND
Akin-Akintayo OO, Jani AB, Odewole O, Tade FI, Nieh PT, Master VA, Bellamy LM, Halkar RK, Zhang C, Chen Z, Goodman MM, Schuster DM. Change in Salvage Radiotherapy Management Based on Guidance With FACBC (Fluciclovine) PET/CT in Postprostatectomy Recurrent Prostate Cancer. Clin Nucl Med. 2017 Jan;42(1):e22-e28. doi: 10.1097/RLU.0000000000001379.
Reference Type
BACKGROUND
Bruce JY, Lang JM, McNeel DG, Liu G. Current controversies in the management of biochemical failure in prostate cancer. Clin Adv Hematol Oncol. 2012 Nov;10(11):716-22.
Reference Type
BACKGROUND
Paller CJ, Antonarakis ES. Management of biochemically recurrent prostate cancer after local therapy: evolving standards of care and new directions. Clin Adv Hematol Oncol. 2013 Jan;11(1):14-23.
Reference Type
BACKGROUND
Ost P, Reynders D, Decaestecker K, Fonteyne V, Lumen N, De Bruycker A, Lambert B, Delrue L, Bultijnck R, Claeys T, Goetghebeur E, Villeirs G, De Man K, Ameye F, Billiet I, Joniau S, Vanhaverbeke F, De Meerleer G. Surveillance or Metastasis-Directed Therapy for Oligometastatic Prostate Cancer Recurrence: A Prospective, Randomized, Multicenter Phase II Trial. J Clin Oncol. 2018 Feb 10;36(5):446-453. doi: 10.1200/JCO.2017.75.4853. Epub 2017 Dec 14.
Reference Type
BACKGROUND
Radwan N, Phillips R, Ross A, Rowe SP, Gorin MA, Antonarakis ES, Deville C, Greco S, Denmeade S, Paller C, Song DY, Diehn M, Wang H, Carducci M, Pienta KJ, Pomper MG, DeWeese TL, Dicker A, Eisenberger M, Tran PT. A phase II randomized trial of Observation versus stereotactic ablative RadiatIon for OLigometastatic prostate CancEr (ORIOLE). BMC Cancer. 2017 Jun 29;17(1):453. doi: 10.1186/s12885-017-3455-6.
Reference Type
BACKGROUND
Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, Olmos D, Mainwaring PN, Lee JY, Uemura H, Lopez-Gitlitz A, Trudel GC, Espina BM, Shu Y, Park YC, Rackoff WR, Yu MK, Small EJ; SPARTAN Investigators. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. N Engl J Med. 2018 Apr 12;378(15):1408-1418. doi: 10.1056/NEJMoa1715546. Epub 2018 Feb 8.
Reference Type
BACKGROUND
Bach-Gansmo T, Nanni C, Nieh PT, Zanoni L, Bogsrud TV, Sletten H, Korsan KA, Kieboom J, Tade FI, Odewole O, Chau A, Ward P, Goodman MM, Fanti S, Schuster DM, Willoch F. Multisite Experience of the Safety, Detection Rate and Diagnostic Performance of Fluciclovine (18F) Positron Emission Tomography/Computerized Tomography Imaging in the Staging of Biochemically Recurrent Prostate Cancer. J Urol. 2017 Mar;197(3 Pt 1):676-683. doi: 10.1016/j.juro.2016.09.117. Epub 2016 Oct 13.
Reference Type
BACKGROUND
Andriole GL, Kostakoglu L, Chau A, Duan F, Mahmood U, Mankoff DA, Schuster DM, Siegel BA; LOCATE Study Group. The Impact of Positron Emission Tomography with 18F-Fluciclovine on the Treatment of Biochemical Recurrence of Prostate Cancer: Results from the LOCATE Trial. J Urol. 2019 Feb;201(2):322-331. doi: 10.1016/j.juro.2018.08.050.
Reference Type
BACKGROUND
Related Links
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https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208054s000lbl.pdf
Axumin FDA prescribing information
Other Identifiers
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BED-IIT 280
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UVMCC1905
Identifier Type: -
Identifier Source: org_study_id
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