CAM 60137

Radioimmunoscintigraphy (Monoclonal Antibody Imaging) With Indium 111 Capromab Pendetide for Prostate Cancer

Category:Radiology   Last Reviewed:December 2019
Department(s):Medical Affairs   Next Review:December 2020
Original Date:December 2002    

Description:
Radioimmunoscintigraphy (RIS) involves the administration of radiolabeled monoclonal antibodies, which are directed against specific molecular targets, followed by imaging with an external gamma camera. Indium 111 capromab pendetide (ProstaScint) is a monoclonal antibody directed against a binding site on prostate-specific antigen.

For individuals who have prostate cancer and are undergoing staging before curative treatment who receive RIS with indium 111 capromab pendetide, the evidence includes diagnostic accuracy studies and a systematic review (TEC Assessment). Relevant outcomes are overall survival, disease-specific survival, test accuracy and test validity. For pretreatment staging before curative treatment, a TEC Assessment found that RIS has a modest sensitivity, estimated at 50% to 75%, and a moderate to high specificity, estimated at 72% to 93%. No studies have demonstrated that the use of RIS for pretreatment staging changes patient management or improves health outcomes. The evidence is insufficient to determine the effects of the technology on health outcomes. 

For individuals who have prostate cancer and have biochemical failure after curative treatment who receive RIS with indium 111 capromab pendetide, the evidence includes case series. Relevant outcomes are overall survival, disease-specific survival, test accuracy and test validity. The available case series were generally retrospective, descriptive and did not provide consistent verification of disease status. Thus, the studies do not permit accurate estimation of the rate of false-positive and false-negative RIS. There is a lack of published evidence demonstrating an association between RIS findings and change in patient management or health outcomes in this population of patients. The evidence is insufficient to determine the effects of the technology on health outcomes.

Background
Radioimmunoscintigraphy is an imaging modality that uses radiolabeled monoclonal antibodies (MAbs) to target specific tissue types. MAbs that react with specific cellular antigens are conjugated with a radiolabeled isotope. The labeled antibody-isotope conjugate is then injected into the patient and allowed to localize to the target over a 2- to 7-day period. The patient 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.

Regulatory Status
In 1996, indium 111 capromab pendetide (ProstaScint®) (also referred to as CYT-356), which targets an intracellular binding site on prostate-specific membrane antigen, and was approved by the U.S. Food and Drug Administration through the biologics license application process for use as a "diagnosing imaging agent in newly-diagnosed patients with biopsy-proven prostate cancer, thought to be clinically-localized after standard diagnostic evaluation … who are at high-risk for pelvic lymph node metastases… [It] is also indicated … in post-prostatectomy patients with a rising PSA [prostate-specific antigen] and a negative or equivocal standard metastatic evaluation in whom there is a high clinical suspicion of occult metastatic disease."1 Other monoclonal antibodies, directed at extracellular prostate-specific membrane antigen binding sites, are also under development.

Policy
Radioimmunoscintigraphy using indium-111 capromab pendetide (ProstaScint®) is considered INVESTIGATIONAL for the evaluation and management of individuals with prostate cancer. 

Benefit Application
BlueCard®/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational. Therefore, FDA-approved devices may be assessed only on the basis of their medical necessity.

Rationale
This evidence review was created in December 2002 and has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through July 8, 2019.

This review was informed by a TEC Assessment (1998).2,

Evidence reviews assess whether a medical test is clinically useful. A useful test provides information to make a clinical management decision that improves the net health outcome. That is, the balance of benefits and harms is better when the test is used to manage the condition than when another test or no test is used to manage the condition.

The first step in assessing a medical test is to formulate the clinical context and purpose of the test. The test must be technically reliable, clinically valid, and clinically useful for that purpose. Evidence reviews assess the evidence on whether a test is clinically valid and clinically useful. Technical reliability is outside the scope of these reviews, and credible information on technical reliability is available from other sources.

Staging Before Curative Treatment
Clinical Context and Test Purpose
The purpose of radioimmunoscintigraphy (RIS) in men with prostate cancer who are undergoing staging before curative treatment is to detect distant metastases not evident on other imaging studies because detection of occult metastases in pelvic lymph nodes is likely to alter treatment recommendations.

The question addressed in this evidence review is: Does the use of RIS improve the net health outcome in men with prostate cancer undergoing pretreatment workup for cancer staging?

The following PICOs were used to select literature to inform this review.

Patients
The relevant population of interest are men with prostate cancer undergoing pretreatment cancer staging for curative treatment.

Interventions
The test being considered is RIS.

RIS is injected in a clinical facility certified to use radiopharmaceuticals, with imaging taking place in an outpatient setting two to seven days later.

Comparators
The following tests are currently being used to make decisions about pretreatment workup of men with prostate cancer undergoing staging: bone scan, ultrasonography, computed tomography (CT), and magnetic resonance imaging.

Outcomes
The general outcomes of interest are overall survival (OS), test accuracy, and tumor recurrence.

Follow-up for post-RIS injection imaging is up to one week.

Study Selection Criteria
For the evaluation of the clinical validity of the RIS, studies that met the following eligibility criteria were considered:

  • Reported on the accuracy of the marketed version of the technology (including any algorithms used to calculate scores)
  • Included a suitable reference standard (describe the reference standard)
  • Patient/sample clinical characteristics were described
  • Patient/sample selection criteria were described.

Technically Reliable
Assessment of technical reliability focuses on specific tests and operators and requires a review of unpublished and often proprietary information. Review of specific tests, operators, and unpublished data are outside the scope of this evidence review and alternative sources exist. This evidence review focuses on the clinical validity and clinical utility.

Clinically Valid
A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).

Systematic Reviews
Based on the TEC Assessment (1998) of RIS, sensitivity in detecting tumors in the pelvic lymph nodes ranged from 50% to 75% and specificity ranged from 72% to 92.6%.2, Pooled data from the studies reviewed in the TEC Assessment produced an estimated 61% positive predictive value. If positive RIS results were used to exclude a patient from receiving potentially curative therapy (ie, radical prostatectomy), then 38% of patients might be harmed by inappropriately withholding the potentially curative treatment. A pooled negative predictive value of 73% has suggested that if RIS played a key role in determining that pelvic lymph nodes were clear of the tumor before radical prostatectomy, then 26.7% of patients with a negative RIS scan and truly positive lymph nodes might receive ineffective surgery. Also, there is debate over a potential survival benefit with prostatectomy in the setting of positive lymph nodes.3,4, Nevertheless, regarding evaluating the pelvic nodes, the positive predictive values, and negative predictive values were not sufficiently high to avoid pelvic lymph node dissection when necessary to determine patient management.

Nonrandomized Studies
Since that TEC Assessment, reports have addressed the role of RIS in evaluating pelvic lymph node staging.5,6,7,8,9,10, Some of them appear in multiple publications, and population studies may overlap with results from multicenter studies. Moreover, the diagnostic accuracy of RIS for evaluating pelvic lymph nodes did not improve substantially over time.10,

Additional reports have used predictive modeling or cross-sectional correlation analysis to explore the value of RIS results in predicting the extent of disease compared with other factors (eg, prostate-specific antigen [PSA] level, Gleason score, clinical stage of disease).7,8,11, Some of these are mentioned but are not the focus of this review.

Reiter et al (2011) published a retrospective review of 197 patients who had both RIS and histopathology available at a single-institution over a 4-month period.12, For detection of positive lymph nodes, the sensitivity of RIS was 60.0% (95% confidence interval, 14.7% to 94.7%) and the specificity was 97.4% (95% confidence interval, 92.3% to 100%). The area under the receiver operating characteristic curve was 0.787. Increasing Gleason score and clinical setting of pretreatment evaluation were predictive of a positive RIS scan.

Clinically Useful
A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, or more effective therapy, or avoid unnecessary therapy, or avoid unnecessary testing.

Direct Evidence
Direct evidence of clinical utility is provided by studies that have compared health outcomes for patients managed with and without the test. Because these are intervention studies, the preferred evidence would be from randomized controlled trials.

No direct evidence was identified addressing the clinical utility of RIS for this indication.

Chain of Evidence
Indirect evidence on clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility.

Analyses discussed in the section on clinical validity would suggest that RIS provides additional and independent information that correlates with the extent of disease; however, the conclusions from these studies do not directly translate into how RIS results would be used to guide management that improves net health outcome. Without an understanding of diagnostic accuracy and how results would influence management, it is not possible to model potential effects on health outcomes. Thus, none of the reports identified to support the clinical effectiveness of using RIS to evaluate pelvic lymph nodes.

Section Summary: Staging Before Curative Treatment
For pretreatment staging before curative treatment, RIS has a modest sensitivity (estimated at 50% to 75%) and a moderate to high specificity (estimated at 72% to 93%). No studies have demonstrated that the use of RIS for pretreatment staging changes patient management or improves health outcomes.

Biochemical Failure After Prostatectomy or Radiotherapy
Clinical Context and Test Purpose
The purpose of RIS in men with prostate cancer and biochemical failure (ie, a rising PSA) after curative treatment is to differentiate between local and distant recurrence because local recurrence may be treated with salvage radiotherapy, while distant recurrence is usually treated with androgen deprivation therapy.

The question addressed in this evidence review is: Does the use of RIS improve the net health outcome in men with prostate cancer who experience biochemical failure after curative treatment?

The following PICOs were used to select literature to inform this review.

Patients
The relevant population of interest are men with prostate cancer and biochemical failure after curative treatment.

Interventions
The test being considered is RIS.

RIS is injected in a clinical facility certified to use radiopharmaceuticals, with imaging taking place in an outpatient setting two to seven days later.

Comparators
The following tests are currently being used to make decisions about monitoring men with prostate cancer and biochemical failure after curative treatment: bone scan, ultrasonography, CT, and magnetic resonance imaging.

Outcomes
The general outcomes of interest are OS, test accuracy, biochemical-free recurrence, and tumor recurrence.

Follow-up for post-RIS injection imaging is up to one week.

Study Selection Criteria
For the evaluation of the clinical validity of the RIS, see the criteria outlined for the previous indication.

Technically Reliable
Assessment of technical reliability focuses on specific tests and operators and requires a review of unpublished and often proprietary information. Review of specific tests, operators, and unpublished data are outside the scope of this evidence review and alternative sources exist. This evidence review focuses on the clinical validity and clinical utility.

Clinically Valid
A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).

There are limited data showing that the use of RIS to evaluate patients with the recurrent or residual disease can detect additional sites of disease better than usual care.7,9,10,11,13,14,15,16,17,18, Imaging evaluation may be useful in suspected recurrence due to rising PSA levels to localize the recurrent tumor and to determine whether the recurrent tumor is local to the prostate area, involves distant sites, or both. When the residual or recurrent disease is only local, patients may undergo postoperative radiotherapy, while when the recurrence includes distant sites, hormonal therapy would be considered. Distant hematogenous metastasis from prostate cancer most frequently involves bone but can infrequently involve other soft tissue sites. A bone scan is generally considered more sensitive than RIS for detecting bone metastases.10, Positive RIS findings have been reported anecdotally in abnormalities other than prostate cancer, so biopsy confirmation of unexpected distant findings may be necessary to ensure proper patient management.19,20,21,

Available studies are generally retrospective, descriptive reports of patterns of RIS uptake in patients with suspected recurrence. These studies, however, do not provide consistent verification of disease status, and thus the false-positive and false-negative rates in RIS studies were not well-established. While some studies have reported the percentage of cases that had associated changes in management, it is frequently difficult to determine specifically how RIS results affected management and to determine whether these changes resulted in improved net health outcomes.

Liauw et al (2008) reported on 82 patients with adenocarcinoma of the prostate treated with salvage radiotherapy for an elevated PSA level after prostatectomy.22, The median PSA level before radiotherapy was 0.63 ng/mL. Of the 82 patients, 47 (57%) had a RIS (ProstaScint) scan before radiotherapy, which was used for both patient selection and target delineation. Patients with a RIS scan before radiotherapy had a lower preoperative PSA level (p=0.024) and shorter follow-up (p=0.022) than those without RIS. With a median follow-up of 44 months, the biochemical control rate was 56% at 3 years and 48% at 5 years. Margin status was the only factor associated with a biochemical control on univariate (p=0.005) and multivariate (p=0.004) analyses. Patients who had prostate bed-only uptake on RIS (n=38) did not have improved outcomes, with biochemical control rates of 51% at 3 years and 40% at 5 years. These data would support the conclusion that patients selected for treatment with RIS would not have better biochemical outcomes.

Nagda et al (2007) reported on a series of 58 patients who had ProstaScint scans as part of an assessment of rising PSA levels after prostatectomy who were then treated with prostate bed radiotherapy.23, The 4-year biochemical relapse-free survival (BRFS) rates for patients with negative ProstaScint scans (53%), positive in the prostate bed alone (45%), or positive scan findings elsewhere (74%) did not differ significantly (p=0.51). The capromab pendetide scan status did not affect BRFS. Those with a PSA level before radiotherapy of less than 1 ng/mL had improved BRFS (p=0.003). The authors concluded that the capromab pendetide scan had a low, positive predictive value in patients with positive uptake elsewhere and the four-year BRFS was similar to that for those who did not exhibit positive uptake elsewhere.

Proano et al (2006) reported on "early experience" outcomes among 44 patients with biochemical recurrence after radical prostatectomy who underwent a ProstaScint scan immediately before salvage radiotherapy.24, They noted improved prognosis (mean follow-up, 22 months) in patients who had a negative scan before radiotherapy but also noted that this finding was not necessarily independent of PSA level before radiotherapy.

Two other publications have raised questions about the accuracy (including sensitivity and specificity) of RIS, coregistered with CT, in imaging localized prostate cancer within the prostate gland and in detecting seminal vesicle invasion.25,26, In a prospective evaluation of 93 patients with recurrent prostate cancer, Schuster et al (2014) reported positron emission tomography-CT with the radiotracer anti-1-amino-3-fluorine 18-fluorocyclobutane-1-carboxylic acid was significantly better in detecting prostatic and extraprostatic prostate cancer recurrence than RIS single-photon emission CT plus CT imaging.27,

A retrospective study by Raj et al (2002) included 252 patients with biochemical failure following radical prostatectomy (PSA level, ≤0.4 ng/mL) who had RIS performed to localize recurrence.17, In this study, 72% of subjects had a positive scan. A localized (prostatic fossa only) uptake pattern was seen in 30.6%, regional uptake pattern (regional lymph nodes plus or minus prostatic fossa and no distant disease) in 42.8%, and distant uptake noted in 29.4%. Only a minority of patients (<20%) had also received a CT scan or bone scan showing positive findings, making comparisons across technologies subject to potential bias. A uniform reference standard was not applied in this study, and detailed follow-up was available for half of the patients (132/255). The study reported sensitivity and specificity rates in a small subset of subjects (ie, 95/252 [38%] subjects) who had some degree of verification of disease status. Reported sensitivity was 73%, and specificity was 53%. However, due to the select nature of the small subset analysis, these estimates were subject to potential verification bias and may not be considered valid measures of expected performance.

Sodee et al (2000) retrospectively analyzed 2290 RIS scans in 2154 patients with prostate cancer, either before or after treatment.11, This large multicenter study reported the rates of positive RIS scans in local, regional, and distant sites but did not provide detailed verification of results and, thus, sensitivity and specificity rates could not be determined. When the analysis was stratified by primary treatment (ie, surgery, radiotherapy, or hormonal therapy), RIS showed uptake limited to extrapelvic nodes in 8.5% to 15.1% of patients and uptake in both pelvic and extrapelvic nodes in 22.1% to 33.2% of patients. Relatively few patients also had CT scans (n=146). When CT was compared with RIS, CT did not detect pelvic or extrapelvic nodes detected by RIS in 73% of CT cases.

Clinically Useful
A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, or more effective therapy, or avoid unnecessary therapy, or avoid unnecessary testing.

Direct Evidence
Direct evidence of clinical utility is provided by studies that have compared health outcomes for patients managed with and without the test. Because these are intervention studies, the preferred evidence would be from randomized controlled trials.

No randomized trials were identified, and the retrospective study by Raj et al (2002), discussed above, did not report the proportion of subjects in whom patient management was altered by RIS findings.17,

Chain of Evidence
Indirect evidence on clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility.

Because the clinical validity of RIS for this indication has not been established, a chain of evidence supporting clinical utility cannot be constructed.

Section Summary: Biochemical Failure After Prostatectomy or Radiotherapy
Numerous small case series have evaluated RIS in patients with biochemical failure after curative treatment and described rates of positivity for the local and distant disease. Limitations included the generally retrospective and descriptive nature of the studies and the lack of consistent verification of disease status. Thus, the studies do not permit accurate estimation of the false-positive and false-negative rate RIS. Moreover, no studies identified demonstrated an association between RIS findings and change in patient management or improved health outcomes in this population of patients.

Summary of Evidence
For individuals who have prostate cancer and are undergoing staging before curative treatment who receive RIS with indium 111 capromab pendetide, the evidence includes diagnostic accuracy studies and a systematic review (TEC Assessment). The relevant outcomes are OS, disease-specific survival, test accuracy, and test validity. For pretreatment staging before curative treatment, the TEC Assessment found that RIS has a modest sensitivity, estimated at 50% to 75%, and a moderate to high specificity, estimated at 72% to 93%. No studies have demonstrated that the use of RIS for pretreatment staging changes patient management or improves health outcomes. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have prostate cancer and have biochemical failure after curative treatment who receive RIS with indium 111 capromab pendetide, the evidence includes case series. The relevant outcomes are OS, disease-specific survival, test accuracy, and test validity. The available case series are generally retrospective, descriptive, and do not provide consistent verification of disease status. Thus, the studies do not permit accurate estimation of the false-positive and false-negative rates with RIS. There is a lack of published evidence demonstrating an association between RIS findings and change in patient management or health outcomes in this population of patients. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements
National Comprehensive Cancer Network

The National Comprehensive Cancer Network (v.2.2019) guidelines for prostate cancer do not mention ProstaScint or radioimmunoscintigraphy.28,

American College of Radiology
The American College of Radiology's (2017) Appropriateness Criteria rated the appropriateness of various imaging tests in men with rising prostate-specific antigen levels after prostatectomy or radiotherapy.29, Indium 111 capromab pendetide (ProstaScint) scans were found to be "not routinely used in the evaluation of prostate cancer recurrence" and studies "have demonstrated no benefit with use of capromab pendetide in selection of patients for local salvage therapy." It was also noted that for salvage therapy with a rising prostate-specific antigen, use of "ProstaScint provided no incremental value in appropriately selected patients compared to basic clinicopathologic factors alone."

U.S. Preventive Services Task Force Recommendations
Not applicable.

Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in July 2019 did not identify any ongoing or unpublished trials that would likely influence this review.

References: 

  1. EUSA Pharma (USA). ProstaScint Kit (capromab pendetide). Kit for the Preparation of Indium In 111 Capromab Pendetide. 2012; https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103608s5043lbl.pdf. Accessed August 8, 2018.
  2. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Radioimmunoscintigraphy for Prostate Cancer Update. TEC Assessments. 1998;13;Tab 21.
  3. Lange PH. PROSTASCINT scan for staging prostate cancer. Urology. Mar 2001;57(3):402-406. PMID 11248606.
  4. Moul JW, Kane CJ, Malkowicz SB. The role of imaging studies and molecular markers for selecting candidates for radical prostatectomy. Urol Clin North Am. Aug 2001;28(3):459-472. PMID 11590806.
  5. Lau HY, Kindrachuk G, Carter M, et al. Surgical confirmation of ProstaScint abnormalities in two patients with high risk prostate cancer. Can J Urol. Feb 2001;8(1):1199-1202. PMID 11268308.
  6. Manyak MJ, Hinkle GH, Olsen JO, et al. Immunoscintigraphy with indium-111-capromab pendetide: evaluation before definitive therapy in patients with prostate cancer. Urology. Dec 1999;54(6):1058-1063. PMID 10604708.
  7. Murphy GP, Snow PB, Brandt J, et al. Evaluation of prostate cancer patients receiving multiple staging tests, including ProstaScint scintiscans. Prostate. Feb 1 2000;42(2):145-149. PMID 10617872.
  8. Polascik TJ, Manyak MJ, Haseman MK, et al. Comparison of clinical staging algorithms and 111indium- capromab pendetide immunoscintigraphy in the prediction of lymph node involvement in high risk prostate carcinoma patients. Cancer. Apr 1 1999;85(7):1586-1592. PMID 10193950.
  9. Quintana JC, Blend MJ. The dual-isotope ProstaScint imaging procedure: clinical experience and staging results in 145 patients. Clin Nucl Med. Jan 2000;25(1):33-40. PMID 10634528.
  10. Rosenthal SA, Haseman MK, Polascik TJ. Utility of capromab pendetide (ProstaScint) imaging in the management of prostate cancer. Tech Urol. Mar 2001;7(1):27-37. PMID 11272670 Prostate Cancer.
  11. Sodee DB, Malguria N, Faulhaber P, et al. Multicenter ProstaScint imaging findings in 2154 patients with prostate cancer. The ProstaScint Imaging Centers. Urology. Dec 20 2000;56(6):988-993. PMID 11113745.
  12. Rieter WJ, Keane TE, Ahlman MA, et al. Diagnostic performance of In-111 capromab pendetide SPECT/CT in localized and metastatic prostate cancer. Clin Nucl Med. Oct 2011;36(10):872-878. PMID 21892036.
  13. Elgamal AA, Troychak MJ, Murphy GP. ProstaScint scan may enhance identification of prostate cancer recurrences after prostatectomy, radiation, or hormone therapy: analysis of 136 scans of 100 patients. Prostate. Dec 1 1998;37(4):261-269. PMID 9831223.
  14. Kahn D, Williams RD, Haseman MK, et al. Radioimmunoscintigraphy with In-111-labeled capromab pendetide predicts prostate cancer response to salvage radiotherapy after failed radical prostatectomy. J Clin Oncol. Jan 1998;16(1):284-289. PMID 9440754.
  15. Murphy GP, Elgamal AA, Troychak MJ, et al. Follow-up ProstaScint scans verify detection of occult soft-tissue recurrence after failure of primary prostate cancer therapy. Prostate. Mar 1 2000;42(4):315-317. PMID 10679761.
  16. Petronis JD, Regan F, Lin K. Indium-111 capromab pendetide (ProstaScint) imaging to detect recurrent and metastatic prostate cancer. Clin Nucl Med. Oct 1998;23(10):672-677. PMID 9790041.
  17. Raj GV, Partin AW, Polascik TJ. Clinical utility of indium 111-capromab pendetide immunoscintigraphy in the detection of early, recurrent prostate carcinoma after radical prostatectomy. Cancer. Feb 15 2002;94(4):987-996. PMID 11920467.
  18. 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. Oct 1999;162(4):1322-1328. PMID 10492189.
  19. Khan A, Caride VJ. Indium-111 capromab pendetide (ProstaScint) uptake in neurofibromatosis. Urology. Jul 1 2000;56(1):154. PMID 10869655.
  20. Michaels EK, Blend M, Quintana JC. 111Indium-capromab pendetide unexpectedly localizes to renal cell carcinoma. J Urol. Feb 1999;161(2):597-598. PMID 9915456.
  21. Scott DL, Halkar RK, Fischer A, et al. False-positive 111 indium capromab pendetide scan due to benign myelolipoma. J Urol. Mar 2001;165(3):910-911. PMID 11176508.
  22. Liauw SL, Weichselbaum RR, Zagaja GP, et al. Salvage radiotherapy after postprostatectomy biochemical failure: does pretreatment radioimmunoscintigraphy help select patients with locally confined disease? Int J Radiat Oncol Biol Phys. Aug 1 2008;71(5):1316-1321. PMID 18234446.
  23. Nagda SN, Mohideen N, Lo SS, et al. Long-term follow-up of 111In-capromab pendetide (ProstaScint) scan as pretreatment assessment in patients who undergo salvage radiotherapy for rising prostate-specific antigen after radical prostatectomy for prostate cancer. Int J Radiat Oncol Biol Phys. Mar 1 2007;67(3):834-840. PMID 17293236.
  24. Proano JM, Sodee DB, Resnick MI, et al. The impact of a negative (111)indium-capromab pendetide scan before salvage radiotherapy. J Urol. May 2006;175(5):1668-1672. PMID 16600726.
  25. Mouraviev V, Madden JF, Broadwater G, et al. Use of 111in-capromab pendetide immunoscintigraphy to image localized prostate cancer foci within the prostate gland. J Urol. Sep 2009;182(3):938-947. PMID 19616259.
  26. Tsivian M, Wright T, Price M, et al. 111-In-capromab pendetide imaging using hybrid-gamma camera-computer tomography technology is not reliable in detecting seminal vesicle invasion in patients with prostate cancer. Urol Oncol. Mar-Apr 2012;30(2):150-154. PMID 20189846.
  27. Schuster DM, Nieh PT, Jani AB, et al. 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. May 2014;191(5):1446- 1453. PMID 24144687.
  28. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer. Version 2.2019. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed July 21, 2019.
  29. American College of Radiology. ACR Appropriateness Criteria: Post-Treatment Followup of Prostate Cancer. 2017; https://www.guidelinecentral.com/summaries/acr-appropriateness-criteria-post-treatment-follow-up-of- prostate-cancer/#section-society. Accessed August 9, 2018. 

Coding Section

Codes Number Description
CPT 78800 Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); limted area 
  78801 Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); multipke areas 
  78802 Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); whole body, single day imaging 
  78803 Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); tomographic (SPECT) 
  78804 Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); whole body, requiring 2 or more days imaging 
ICD-9 Procedure  92.16  Scan of lymphatic system 
  92.18  Total body scan, radioisotope 
  92.19 Scan, other sites 
ICD-9 Diagnosis    Investigational for all relevant diagnoses 
  185  Malignant neoplasm of prostate 
  V10.46  Personal history of prostate cancer 
HCPCS A9507  Indium In-111 capromab pendetide, diagnostic, per study does, up to 10 millicuries 
ICD-10-CM (effective 10/01/15)    Investigational for all relevant diagnoses 
  C61 Malignant neoplasm prostrate 
  Z45.46  Personal history malignant neoplasm prostrate 
ICD-10-PCS (effective 10/01/15)      ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for this imaging
  C72YYZZ  Tomographic nuclear medicine imaging lymphatic and hematologic system other radionuclide 
  C75YYZZ  Nonimaging nuclear medicine probe lymphatic and hematologic system other radionuclide 
  C76YYZZ  Planar nuclear medicine imaging male reproductive system other radionuclide 
  CW1ZYZZ  Planar nuclear medicine imaging anatomical regions, other, other radionuclide 
Type of Service    Radiology  
Place of Service Outpatient  

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

Index 
Capromab Pendetide
Indium-111 Capromab Pendetide
ProstaScint®
Radioimmunoscintigraphy

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association.  All Rights Reserved" 

History From 2013 Forward     

12/02/2019 

Annual review, no change to policy intent. Updating rationale and references. 

12/13/2018 

Annual review, no change to policy intent. Updating rationale and references. 

12/18/2017 

Annual review, no change to policy intent. Updating regulatory status, rationale and references. 

12/01/2016 

Annual review, no change to policy intent. Updating background, description, rationale and references. 

11/16/2015 

Annual review, no change to policy intent. Updated background, description, rationale and references. Added regulatory status. 

12/01/2014 

Annual review. Updated references. Added coding. No change to policy intent. 

12/2/2013

Annual review, added benefit applications and updated references.


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