Request for Pre-Approval
11C-Acetate
PET/CT for Evaluation of Suspected Recurrent Prostate Cancer
RE: ___________________________ (Patient Name and Identifier)
Dr. ___________________________, who is treating Mr. _____________________,
believes that management of this patient’s clinical care would be advanced by performance of a
11C-Acetate PET/CT scan.
The clinical indication for this 11C-Acetate PET/CT study is suspected recurrence of prostate
cancer (a.k.a, biochemical failure) with the clinical need to determine whether there is
local/locoregional, or distant, recurrent disease (or both).
This 11C-Acetate PET/CT assessment of the location and extent of recurrence is expected to
affect therapeutic management, including consideration of a variety of interventions (e.g.,
proceeding to salvage therapy for local recurrence vs. systemic treatment for metastatic disease).
The Indiana University School of Medicine can produce the 11C-Acetate radiopharmaceutical for
this patient’s PET/CT procedure under Physician-Sponsored Expanded Access IND #118204
(James W. Fletcher, M.D., Sponsor).
Imaging studies with other drugs, including fluorodeoxyglucose (18F-FDG) PET and capromab
pendetide (ProstaScint, Cytogen Corp, Princeton, NJ) SPECT, have unfortunately not been
sensitive enough for this evaluation of clinically suspected recurrent disease, and are not
definitively helpful in aiding treatment decisions [1-4].
It is our considered clinical judgment that 11C-acetate PET/CT [2,5,6,7,8,9,10], with an accuracy
that is superior to existing standard of care drugs [1-4], will provide benefit to this patient and
aid in treatment management.
The biochemical foundation for accumulation and retention of radiolabeled acetate in prostate
cancer is primarily incorporation of the radiocarbon into cellular phosphatidylcholine and
neutral lipids [11], with the 11C-acetate effectively serving as an imaging marker for fatty acid
synthase expression [12].
The FDA-authorized charge for this Expanded Access radiopharmaceutical is $2,126.50. This
charge represents the break-even cost of producing the radiopharmaceutical per patient.
The charges to the patient will be the following:
The patient charge for the dose will be $100.00.
The technical charge for performance of the PET CT scan will be $4,200.00.
The professional fee for interpretation and reporting will be $609.00.
Technical questions about the 11C-Acetate PET/CT procedure can be directed to:
Professor James W Fletcher, M.D.
Director of Nuclear Medicine and PET Imaging
Department of Radiology and Imaging Sciences
Indiana University School of Medicine
Indianapolis, IN 46202
317-944-1800
e-mail: jwfletch@iupui.edu
Questions about the clinical need for the 11C-Acetate PET/CT procedure, and how it is expected
to advance this patient’s care, should be directed to:
___________________________, M.D.
Department of __________________________
Indiana University School of Medicine
Indianapolis, IN 46202
317-__________________
e-mail: _________________
The 11C-Acetate PET/CT study cannot be performed for this patient without confirmation that
payment will be made for the procedure.
Literature References
1. Engelbrecht MR, Barentsz JO, Jager GJ, et al. Prostate cancer staging with imaging. BJU
Int. 2000;86 (suppl 1):123–134.
2. Jadvar H. Prostate Cancer: PET with 18F-FDG, 18F- or 11C-Acetate, and 18F or 11C-Choline.
J Nucl Med 2011: 52:81-89.
3. Hofer C, Laubenbacher C, Block T, Breul J, Hartung R, Schwaiger M. Fluorine-18fluorodeoxyglucose positron emission tomography is useless for detection of local
recurrence after radical prostatectomy. Eur Urol.1999; 36:31-35.
4. Seltzer MA, Barbaric Z, Belldegrun A, et al. Comparison of helical computerized
tomography, positron emission tomography and monoclonal antibody scans for
evaluation of lymph node metastases in patients with prostate specific antigen relapse
after treatment for localized prostate cancer. J Urol. 1999;162:1322-1328.
5. Oyama N, Miller TR, Dehdashti F, et al. 11C-acetate PET imaging of prostate cancer:
detection of recurrent disease at PSA relapse. J Nucl Med. 2003;44:549–555.
6. Sandblom G, Sorensen J, Lundin N, et al. Positron emission tomography with 11C-acetate
for tumor detection and localization in patients with prostate specific antigen relapse
after radical prostatectomy. Urology. 2006;67:996–1000.
7. Lee AK, D’Amico AV. Utility of prostate-specific antigen kinetics in addition to clinical
factors in the selection of patients for salvage local therapy. J Clin Oncol. 2005;23:81928197.
8. Czernin J, Benz MR, Allen-Auerbach MS. PET imaging of prostate cancer using 11Cacetate. PET Clin. 2009; 4:163-172.
9. Grassi I, Nanni C, Allegri V, Morigi JJ, Montini GC, Castellucci P, Fanti S. The clinical
use of PET with 11C-acetate. Ann J Nucl Med Mol Imaging 2012; 2:33-47.
10. Jadvar, H. Molecular imaging of prostate cancer: PET radiotracers. AJR 2012; 199:278291.
11. Yoshimoto M, Waki A, Yonekura Y, et al. Characterization of acetate metabolism in
tumor cells in relation to cell proliferation: acetate metabolism in tumor cells. Nucl Med
Biol. 2001;28:117–122.
12. Vavere AL, Kridel SJ, Wheeler FB, et al. 1-11C-acetate as a PET radiopharmaceutical for
imaging fatty acid synthase expression in prostate cancer. J Nucl Med. 2008;49:327–
334.