Regulatory evaluation of prostate volume implants: Pitfalls of a retrospective assessment

Department of Radiation Oncology, Virginia Commonwealth University, Richmond, VA 23298-0058, USA.
Brachytherapy (Impact Factor: 2.76). 02/2011; 10(5):385-94. DOI: 10.1016/j.brachy.2011.01.005
Source: PubMed


Evaluate for regulatory compliance the prostate implants from the Philadelphia Veterans Medical Center applying both an activity-based and volume-corrected D(90) (the maximum dose delivered to 90% of the prostate volume) metrics.
Dosimetry from 107 prostate implants performed at the Philadelphia Veterans Medical Center used immediate postprocedural CT image sets. D(90) values were adjusted for volume differences from planning volumes. Medical events (MEs) determined from the volume-corrected data were compared with an activity-based metric.
Examination of images using original and third-party reviewed prostate contours revealed 56 and 62 cases with D(90) values <80% of the prescription dose, respectively. Because postprocedural prostate volumes were on average 55.7% larger than the planned volume, clinical nomogram-based doses using the implanted activity and actual volumes found 34-47 implants failing to achieve doses greater than 80% of the prescription dose. Volume correction identified 20 MEs, 9 cases with D(90) values within 4% of the ME threshold and 11 significantly inferior cases with median D(90) values <52% of the prescribed dose. Eleven implants also had 20% or more seeds beyond the treatment site according to an activity metric recommended by the VHA Blue Ribbon Panel. Ten of these 11 cases were also identified by volume-corrected D(90) metric. The remaining 96 cases, however, had 95% (±6%) of seeds placed within the treatment site.
Of the cases reported to the United States Nuclear Regulatory Commission (NRC) on the basis of Day-1 D(90) values, many appear to have been acceptable implants relative to standard-of-practice clinical criteria. The activity-based dose metric, endorsed by the NRC Advisory Committee on the Medical Uses of Isotopes in 2005 and recommended by the VHA Blue Ribbon Panel for Prostate Brachytherapy yields a more robust determination of ME for this population of implants.

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    • "This outcome was unfortunately demonstrated in a recent Veterans Affairs Hospital (VAH) audit in which an unacceptable number of permanent prostate implant brachytherapy (97 out of 116 prostate cancer treatment procedures) were deemed as MEs using the existing dose-based ME criterion.12 However, on reanalysis, 80 of these 97 were actually not considered MEs using an implanted source strength-based metric recommended by the “VAH blue ribbon panel” or the Advisory Committee for the Medical Use of Isotopes and the scientific organizations including ASTRO because many of these apparent MEs were due to prostate volume changes.12 It should be noted that the implanted source strength-based ME criteria would still correctly identify the 17 medically unacceptable implants as MEs. "
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    ABSTRACT: The Nuclear Regulatory Commission deems it to be a medical event (ME) if the total dose delivered differs from the prescribed dose by 20% or more. A dose-based definition of ME is not appropriate for permanent prostate brachytherapy as it generates too many spurious MEs and thereby creates unnecessary apprehension in patients, and ties up regulatory bodies and the licensees in unnecessary and burdensome investigations. A more suitable definition of ME is required for permanent prostate brachytherapy. The American Society for Radiation Oncology (ASTRO) formed a working group of experienced clinicians to review the literature, assess the validity of current regulations, and make specific recommendations about the definition of an ME in permanent prostate brachytherapy. The working group found that the current definition of ME in §35.3045 as "the total dose delivered differs from the prescribed dose by 20 percent or more" was not suitable for permanent prostate brachytherapy since the prostate volume (and hence the resultant calculated prostate dose) is dependent on the timing of the imaging, the imaging modality used, the observer variability in prostate contouring, the planning margins used, inadequacies of brachytherapy treatment planning systems to calculate tissue doses, and seed migration within and outside the prostate. If a dose-based definition for permanent implants is applied strictly, many properly executed implants would be improperly classified as an ME leading to a detrimental effect on brachytherapy. The working group found that a source strength-based criterion, of >20% of source strength prescribed in the post-procedure written directive being implanted outside the planning target volume is more appropriate for defining ME in permanent prostate brachytherapy. ASTRO recommends that the definition of ME for permanent prostate brachytherapy should not be dose based but should be based upon the source strength (air-kerma strength) administered.
    Practical Radiation Oncology 10/2011; 1(4):218-223. DOI:10.1016/j.prro.2011.05.001
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    ABSTRACT: Purpose: To describe in detail British Columbia (BC) Cancer Agency (BCCA) Provincial Prostate Brachytherapy (PB) Quality Assurance (QA) Program. Methods and materials: The BCCA PB Program was established in 1997. It operates as one system, unified and supported by electronic and information systems, making it a single PB treatment provider for province of BC and Yukon. To date, >4000 patients have received PB (450 implants in 2011), making it the largest program in Canada. The Program maintains a large provincial prospective electronic database with records on all patients, including disease characteristics, risk stratification, pathology, preplan and postimplant dosimetric data, follow-up of prostate-specific antigen, and toxicity outcomes. Results: QA was an integral part of the program since its inception. A formal QA Program was established in 2002, with key components that include: unified eligibility criteria and planning system, comprehensive database, physics and oncologist training and mentorship programs, peer review process, individual performance outcomes and feedback process, structured continuing education and routine assessment of the program's dosimetry, toxicity and prostate-specific antigen outcomes, administration and program leadership that promotes a strong culture of patient safety. The emphasis on creating a robust, broad-based network of skilled providers has been achieved by the program's requirements for training, education, and the QA process. Conclusions: The formal QA process is considered a key factor for the success of cancer control outcomes achieved at BCCA. Although this QA model may not be wholly transferable to all PB programs, some of its key components may be applicable to other programs to ensure quality in PB and patient safety.
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