DESCRIPTION
Radioimmunoscintigraphy involves the administration of radiolabeled monoclonal antibodies (MAbs), which are directed against specific molecular targets, followed by imaging with an external gamma camera. MAbs that react with specific cellular antigens are conjugated with a radiolabeled isotope. Indium-111 capromab pendetide (e.g., Prostascint®) targets an intracellular binding site on prostate-specific membrane antigen (PSMA). The labeled antibody-isotope conjugate is injected into the individual and allowed to localize to the target over a 2- to 7-day period. The antibodies may light up in areas where the cancer has spread because they are radioactive. The individual then undergoes imaging with a nuclear medicine gamma camera, and radioisotope counts are analyzed. Imaging can be performed with planar techniques or by using single-photon emission computed tomography (SPECT).
POLICY
Radioimmunoscintigraphy imaging with indium-111 capromab pendetide for the diagnosis, treatment or management of prostate cancer is considered investigational.
ADDITIONAL INFORMATION
Current medical literature is insufficient to support conclusions concerning efficacy, optimal use and impact on the diagnosis, treatment or clinical management of prostate cancer using radioimmunoscintigraphy imaging with Indium-111 capromab pendetide. Radioimmunoscintigraphy imaging also continues to be a challenge to interpret.
A number of papers described ongoing efforts related to fused SPECT-CT images in patients with prostate cancer as an approach to improve the accuracy and clinical utility of this imaging technique. Bander reported on use of second-generation antibodies that target extracellular PSMA in an attempt to improve the accuracy of this scan for detecting bone metastases recognizing that bone is the first site of metastatic spread in many patients. Proano reported “early experience” on outcomes among a group of 44 patients with biochemical recurrence after radical prostatectomy and who underwent a ProstaScint scan immediately before salvage radiotherapy. They noted an improved prognosis (mean follow-up of 22 months) in patients who had a negative pre-radiotherapy scan but also noted that this finding was not necessarily independent of pre-radiotherapy PSA level.
SOURCES
Akin, O., & Hricak, H. (2007). Imaging of prostate cancer. Radiologic Clinics of North America, 45 (1), 207-222.
BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2008). Radioimmunoscintigraphy imaging (monoclonal antibody imaging) with indium-111 capromab pendetide (Prostascint®) for prostate cancer (6.01.37). Retrieved June 25, 2009 from BlueWeb. (32 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Information Service. Evidence Reports. (2000, October). 111In-capromab pendetide for staging prostate cancer in men at high risk of metastasis. Retrieved June 25, 2009 from ECRI Institute. (62 articles and/or guidelines reviewed)
Haseman, M. K., Rosenthal, S. A., Kipper, S. L., Trout, J. R., & Manyak, M. J. (2007). Central abdominal uptake of indium-111 capromab pendetide (ProstaScint) predicts for poor prognosis in patients with prostate cancer. Urology, 70 (2), 303-308.
Hayes. Medical Technology Directory. (2007, November). Indium in 111 capromab pendetide (ProstaScint®) radioimmunoscintigraphy for the diagnosis of prostate cancer. Retrieved June 26, 2009 from www.Hayesinc.com/subscribers. (50 articles and/or guidelines reviewed)
National Comprehensive Cancer Network. (2009, February). NCCN clinical practice guidelines in oncology™. Prostate cancer - V.2.2009. Retrieved June 26, 2009 from http://www.nccn.org/professionals/physician_gls/PDF/prostate.pdf.
National Guideline Clearinghouse. (2007). ACR Appropriateness Criteria® pretreatment staging prostate cancer. Retrieved June 26, 2009 from http://www.guidelines.gov.
National Institute for Health and Clinical Excellence (NICE). (2008, February). Prostate cancer. Diagnosis and treatment. Retrieved June 26, 2009 from http://www.nice.org.uk/nicemedia/pdf/CG58NICEGuideline.pdf.
Ross, R., & Harisinghani, M. (2006). Prostate cancer imaging-What the urologic oncologist needs to know. Radiologic Clinics of North America, 44 (5), 711-722.
Schettino, C. J., Kramer, E. L., Noz, M. E., Taneja, S., Padmanabhan, P., & Lepor, H. (2004). Impact of fusion of indium-111 capromab pendetide volume data sets with those from MRI or CT in patients with recurrent prostate cancer. American Journal of Roentgenology, 183 (2), 519-524.
Taneja, S. S. (2004). ProstaScint® scan: Contemporary use in clinical practice. Reviews in Urology, 6 (Suppl. 10), S19-S28.
U. S. Food and Drug Administration. (1996, October). Center for Drug Evaluation and Research. Product Approval Information - Licensing Action. Capromab Pendetide. Retrieved May 15, 2007 from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080734.htm.
ORIGINAL EFFECTIVE DATE: 11/10/2007
MOST RECENT REVIEW DATE: 7/9/2009
ID_BT
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