Consensus recommendations for incident learning database structures in radiation oncology.

PURPOSE: Incident learning plays a key role in improving quality and safety in a wide range of industries and medical disciplines. However, implementing an effective incident learning system is complex, especially in radiation oncology. One current barrier is the lack of technical standards to guide users or developers. This report, the product of an initiative by the Work Group on Prevention of Errors in Radiation Oncology of the American Association of Physicists in Medicine, provides technical recommendations for the content and structure of incident learning databases in radiation oncology. METHODS: A panel of experts was assembled and tasked with developing consensus recommendations in five key areas: definitions, process maps, severity scales, causality taxonomy, and data elements. Experts included representatives from all major North American radiation oncology organizations as well as users and developers of public and in-house reporting systems with over two decades of collective experience. Recommendations were developed that take into account existing incident learning systems as well as the requirements of outside agencies. RESULTS: Consensus recommendations are provided for the five major topic areas. In the process mapping task, 91 common steps were identified for external beam radiation therapy and 88 in brachytherapy. A novel feature of the process maps is the identification of "safety barriers," also known as critical control points, which are any process steps whose primary function is to prevent errors or mistakes from occurring or propagating through the radiotherapy workflow. Other recommendations include a ten-level medical severity scale designed to reflect the observed or estimated harm to a patient, a radiation oncology-specific root causes table to facilitate and regularize root-cause analyses, and recommendations for data elements and structures to aid in development of electronic databases. Also presented is a list of key functional requirements of any reporting system. CONCLUSIONS: Incident learning is recognized as an invaluable tool for improving the quality and safety of treatments. The consensus recommendations in this report are intended to facilitate the implementation of such systems within individual clinics as well as on broader national and international scales.

Long-term urinary function after transperineal brachytherapy for patients with large prostate glands.

PURPOSE: To summarize longer-term postbrachytherapy morbidity in patients with prostate glands >50 cm3. METHODS AND MATERIALS: From 1997 to 1998, 33 patients with a transrectal ultrasound-based prostate volume >50 cm3 were treated at the University of Washington by 125I (144 Gy) or 103Pd (115 Gy) implantation for prostate carcinoma. These 33 patients comprised 7% of the total implant patient population. Twelve patients were treated with neoadjuvant androgen ablation before implantation. The (125)I source strength ranged from 0.34 to 0.5 mCi and the 103Pd source strength ranged from 1.1 to 1.4 mCi (pre-NIST-99). The total number of sources implanted was 94-223 (median 155). Despite the typical implant-related volume increase, the postimplant CT-defined prostate volumes were generally well-covered by the prescription isodose (median coverage 92%, range 80-100%). The preimplant urinary obstructive symptoms were quantified by the criteria of the American Urological Association. RESULTS: Of the 33 patients, 12 developed acute postimplant urinary retention, all presenting within 24 h of implantation. Patients who developed postimplant retention lasting >1 week were generally treated with intermittent self-catheterization. By 1 month, 85% of patients were catheter free. By 1 year, only 1 patient (4%) remained in urinary retention; the remainder of cases had resolved spontaneously. With follow-up of 1.7-2.6 years, the last American Urological Association scores were higher than the pretreatment scores in 15 patients and lower in 7 patients. No patient developed permanent urinary incontinence. Long-term changes in the American Urological Association scores were unrelated to whether the patient had been in urinary retention after implantation. Two patients developed rectal fistulas; they had preimplant transrectal ultrasound prostate volumes of 53 and 59 cm3, in the low range for this group of patients. No other patient had persistent rectal bleeding suggestive of clinically significant proctitis. The pretreatment serum prostate-specific antigen level was 3.3-15 ng/mL (median 7.2) and the last serum prostate-specific antigen level 0.1-1.6 ng/mL (median 0.2). CONCLUSION: Patients with larger prostate volumes appear to have moderate morbidity and a satisfactory technical outcome with brachytherapy. We do not believe the occurrence of two severe rectal complications was related to the prostate volume per se. Our experience and that of others calls into question the validity of using prostate volume as a criterion for patient suitability for prostate brachytherapy.

Short-term sexual function after prostate brachytherapy.

Sexual function was evaluated in 34 patients with low-risk prostate cancer (PSA < or = 10, Gleason score < or = 6, clinical stage T1/T2) undergoing brachytherapy in a phase III prospective randomized trial comparing iodine-125 ((125)I) to palladium-103 ((103)Pd). The mean and median International Index of Erectile Function (IIEF) scores for the entire group were 14.2 and 16.5, respectively, and there was no difference between these scores when stratified by isotope. IIEF scores < 6, 6 to 11, and > or = 12 were recorded in 35% (12/34), 6% (2/34), and 59% (20/34) of patients, respectively. Hematospermia, orgasmalgia (pain at the time of orgasm), and alteration in intensity of orgasm were documented in 26% (9/34), 15% (5/34), and 38% (13/34) of patients, respectively, but these side effects were of limited duration for most patients. There was no relationship between radiation dose to the neurovascular bundles (NVB), which averaged 209% of the prescribed prostate dose, and the development of postbrachytherapy impotence. All four impotent patients who used sildenafil responded favorably. With a median follow-up of 13 months, 65% of patients undergoing prostate brachytherapy maintained sexual function without pharmacologic support. Including sildenafil responses, 76.5% of patients sustained erections sufficient for sexual intercourse.

Argon plasma coagulation for rectal bleeding after prostate brachytherapy.

PURPOSE: To better define the efficacy and safety of argon plasma coagulation (APC), specifically for brachytherapy-related proctitis, we reviewed the clinical course of 7 patients treated for persistent rectal bleeding. Approximately 2-10% of prostate cancer patients treated with 125I or 103Pd brachytherapy will develop radiation proctitis. The optimum treatment for patients with persistent bleeding is unclear from the paucity of available data. Prior reports lack specific dosimetric information, and patients with widely divergent forms of radiation were grouped together in the analyses. METHODS AND MATERIALS: Seven patients were treated with APC at the Veterans Affairs Puget Sound Health Care System and the University of Washington from 1997 to 1999 for persistent rectal bleeding due to prostate brachytherapy-related proctitis. Four patients received supplemental external beam radiation, delivered by a four-field technique. A single gastroenterologist at the Veterans Affairs Puget Sound Health Care System treated 6 of the 7 patients. If the degree of proctitis was limited, all sites of active bleeding were coagulated in symptomatic patients. An argon plasma coagulator electrosurgical system was used to administer treatments every 4-8 weeks as needed. The argon gas flow was set at 1.6 L/min, with an electrical power setting of 40-45 W. RESULTS: The rectal V100 (the total rectal volume, including the lumen, receiving the prescription dose or greater) for the 7 patients ranged from 0.13 to 4.61 cc. Rectal bleeding was first noticed 3-18 months after implantation. APC (range 1-3 sessions) was performed 9-22 months after implantation. Five patients had complete resolution of their bleeding, usually within days of completing APC. Two patients had only partial relief from bleeding, but declined additional APC therapy. No patient developed clinically evident progressive rectal wall abnormalities after APC, (post-APC follow-up range 4-13 months). CONCLUSIONS: Most patients benefited from APC, and no cases of clinically evident progressive tissue destruction were noted. Although APC appears to be efficacious and safe in the setting of the rectal doses described here, caution is in order when contemplating APC for brachytherapy patients.

Practical aspects of in situ 16O (gamma,n) 15O activation using a conventional medical accelerator for the purpose of perfusion imaging.

We report investigations into the feasibility of generating radioactive oxygen (15O, a positron emitter, with half-life 2.05 min) using a tuned Elekta SL25 accelerator, for the end purpose of imaging tumor perfusion. 15O is produced by the "gamma, neutron," (gamma,n) reaction between high-energy photons and normal oxygen (16O) in the body. As most in vivo 16O is bound in water molecules the 15O radio-marker is produced in proportion to water content in tissue. Imaging the washout of the 15O distribution using sensitive positron-emission-tomography (PET) technology can yield spatial information about blood perfusion in the tissue. The aim of this article was to determine the amount of 15O activity that could be produced by the tuned medical accelerator. A further aim was to model the activation process using Monte Carlo and to investigate ways to optimize the amount of 15O that could be generated. Increased activation was achieved by (i) tuning the beam to give higher-energy electrons incident on the target of the accelerator, (ii) increasing dose rate by removing the conventional filtration in the beam and reducing the source to object distance, and (iii) reducing low-energy photons by means of a carbon block absorber. The activity per-unit-dose produced by the tuned beam was measured by irradiating spheres of water to known doses and placing the spheres in a calibrated coincidence-counting apparatus. Peak energy of the tuned bremsstrahlung beam was estimated at 29 MeV, and generated activity up to 0.24/microCi/cc/3Gy in water. The measured amount of 15O agreed to within 10% of the prediction from the Monte-Carlo-computed spectrum, indicating reasonable ability to model the activation process. The optimal thickness of the carbon absorber was found to be about 25 cm. The insertion of a carbon absorber improved spectral quality for activation purposes but at the cost of reduced dose rate. In conclusion, the viability of generating 15O with an Elekta SL25 has been demonstrated. In conjunction with recent advances in high-sensitivity portable PET imaging devices, real potential exists for imaging in situ activated 15O washout as a surrogate measurement of macroscopic tumor perfusion.

Standardization of prostate brachytherapy treatment plans.

PURPOSE: Whereas custom-designed plans are the norm for prostate brachytherapy, the relationship between linear prostate dimensions and volume calls into question the routine need for customized treatment planning. With the goal of streamlining the treatment-planning process, we have compared the treatment margins (TMs) achieved with one standard plan applied to patients with a wide range of prostate volumes. METHODS AND MATERIALS: Preimplant transrectal ultrasound (TRUS) images of 50 unselected University of Washington patients with T1-T2 cancer and a prostate volume between 20 cc and 50 cc were studied. Patients were arbitrarily grouped into categories of 20-30 cc, 30-40 cc, and 40-50 cc. A standard 19-needle plan was devised for patients in the 30- to 40-cc range, using an arbitrary minimum margin of 5 mm around the gross tumor volume (GTV), making use of inverse planning technology to achieve 100% coverage of the target volume with accentuation of dose at the periphery and sparing of the central region. The idealized plan was applied to each patient's TRUS study. The distances (TMs) between the prostatic edge (GTV) and treated volume (TV) were determined perpendicular to the prostatic margin. RESULTS: Averaged over the entire patient group, the ratio of thickness to width was 1.4, whereas the ratio of length to width was 1.3. These values were fairly constant over the range of volumes, emphasizing that the prostate retains its general shape as volume increases. The idealized standard plan was overlaid on the ultrasound images of the 17 patients in the 30- to 40-cc group and the V100, the percentage of target volume receiving 100% or more of the prescription dose, was 98% or greater for 15 of the 17 patients. The lateral and posterior TMs fell within a narrow range, most being within 2 mm of the idealized 5-mm TM. To estimate whether a 10-cc volume-interval stratification was reasonable, the standard plan generated from the 30- to 40-cc prostate model was applied to 5 patients each from the 20- to 30-cc group and the 40- to 50-cc group. Using the standard plan designed for the 30- to 40-cc group, the TMs were closer to 10 mm than to 5 mm for the smaller volume glands and too small for the larger volume ones, assuming an ideal margin of 5 mm. CONCLUSION: The application of standardized plans to prostate brachytherapy is feasible. Stratifying the volume in 10-cc intervals appears to be adequate, suggesting that the majority of cases appropriate for treatment with brachytherapy might be treated with three standard plans. While the authors believe that the use of a limited number of standard treatment plans is feasible, practical, and medically acceptable, it should be emphasized that the use of a standard plan should always be previewed by computer-aided application to the particular patient's planning images.

Transperineal brachytherapy in patients with large prostate glands.

The purpose of this study is to help clarify the use of prostate size as a selection factor for prostate brachytherapy. From 1997 to 1998, 33 patients with a TRUS-based prostate volume greater than 50 cc were treated at the University of Washington by I-125 (144 Gy) or Pd-103 (115 Gy) implantation for prostatic carcinoma. These 33 patients comprised 7% of the total implants performed. Each patient underwent a preimplant TRUS study in the lithotomy position, taking serial axial images of the prostate at 0.5 cm intervals from the base of the gland to the apex. The contours on the preimplant TRUS images were used to calculate the prostate volumes reported here. Only one patient received supplemental external beam irradiation prior to implantation. Twelve patients were treated with neoadjuvant androgen ablation prior to implantation. The prostate volumes quoted here are those taken after hormonal downsizing. Postimplant axial CT images were digitized to calculate the CT-based target coverage. Preimplant urinary obstructive symptoms were quantified by the criteria of the American Urologic Association. Each patient was contacted at the time of this article preparation to update postimplant morbidity information. In all cases, at least 80% of the postimplant volume was covered, despite a median implant-related volume increase of 15%. Five of the 33 patients' postimplant CT scans showed some degree of incomplete target coverage of the anterior/lateral prostate margin. There was no clear association between inadequate anterior/lateral coverage and the degree of interference. Twelve of the 33 patients developed acute postimplant urinary retention, all occurring within 24 hr of implantation. Within this group of 33 patients with a large prostate volume, there was no relationship between the likelihood of acute or chronic urinary retention and preimplant prostate size or obstructive symptoms. Patients who developed postimplant retention lasting more than one week were generally managed by intermittent self-catheterization. By one month, 85% of patients were catheter-free. Based on the data reported here, we are more inclined to accept patients with a large prostate for implantation without insisting on preimplant size reduction. Int. J. Cancer (Radiat. Oncol. Invest.) 90, 199-205 (2000).

Prostate brachytherapy in patients with median lobe hyperplasia.

Our aim was to document the technical and clinical course of prostate brachytherapy patients with radiographic evidence of median lobe hyperplasia (MLH). Eight patients with MLH were identified during our routine brachytherapy practice, representing 9% of the 87 brachytherapy patients treated during a 6-month period. No effort was made to avoid brachytherapy in patients noted to have MLH on diagnostic work-up. Cystoscopic evaluation was not routinely performed. Postimplant axial computed tomographic (CT) images of the prostate were obtained at 0.5 cm intervals. Preimplant urinary obstructive symptoms were quantified by the criteria of the American Urologic Association (AUA). Each patient was contacted during the writing of this report to update postimplant morbidity information. There was no apparent association between the degree of MLH and preimplant prostate volume or AUA score. Intraoperatively, we were able to visualize MLH by transrectal ultrasound and did not notice any particular difficulty placing sources in the MLH tissue or migration of sources out of the tissue. The prescription isodose covered from 81% to 99% of the postimplant CT-defined target volume, achieving adequate dose to the median lobe tissue in all patients. Two of the eight patients developed acute, postimplant urinary retention. The first patient required intermittent self-catheterization for 3 months and then resumed spontaneous urination. MLH does not appear to be a strong contraindication to prostate brachytherapy, and prophylactic resection of hypertrophic tissue in such patients is probably not warranted. Int. J. Cancer (Radiat. Oncol. Invest.) 90, 152-156 (2000).

Treatment margins for prostate brachytherapy.

The purpose of this article was to determine what planned treatment margin (TM) would allow for implant-related prostate volume changes and still achieve an adequate periprostatic cancercidal dose. Twenty consecutive, unselected patients who underwent (125)I implantation (144 Gy prescription dose) were studied. The treated volume (TV) was calculated as the volume encompassed by the 144 Gy isodose distribution. A post-implant computed tomography scan was obtained the following day, using 5-mm images at every 5 mm. The distances between the prostate margin (GTV) and TV were determined by measuring the distance between the ultrasound-defined prostatic margin and the prescription isodose, perpendicular to the prostatic margin. The lateral, anterior, and posterior TM margins were determined at the base, mid-level, and apex of the prostate. The pre-implant TV was nearly twice as large as the GTV, ranging from 36 to 199 mL (median, 73 mL). The anterior, lateral, and posterior planned TMs varied substantially between patients, due to lack of a consistent policy the magnitude of the CTV and the acceptable CTV-to-TV distance. For all measurement points, the median planned treatment margin was 3 mm (range, -16 mm to 14 mm). Overall, there was only a loose correlation between pre- and post-implant treatment margins primarily due to variable, implant-related prostatic dimensional changes. Patients with a greater implant-related volume increase tended to have smaller post-implant treatment margins. The post-implant TMs were negatively correlated with dimensional changes, and the negative correlation was most marked for the anterior and posterior TMs due to predominant anterior-posterior dimensional increase. As expected, the post-implant target coverage was higher when larger planning TMs were used, but the correlation was loose due to the unpredictable, highly variable degree of implant-related volume increase. We currently are using 5-mm TMs around the GTV, as identified on pre-implant transrectal ultrasonography or computed tomography. However, the poor correlation between planned and actual post-implant TMs call into question any attempt to make a rational recommendation regarding optimal TMs.

Brachytherapy radiation doses to the neurovascular bundles.

PURPOSE: To investigate the role of radiation dose to the neurovascular bundles (NVB) in brachytherapy-related impotence. METHODS AND MATERIALS: Fourteen Pd-103 or I-125 implant patients were studied. For patients treated with implant alone, the prostate and margin (clinical target volume [CTV]) received a prescription dose of 144 Gy for I-125 or 115 Gy for Pd-103. Two patients received Pd-103 (90 Gy) with 46 Gy supplemental external beam radiation (EBRT). Axial CT images were acquired 2 to 4 hours postoperatively for postimplant dosimetry. Because the NVBs cannot be visualized on CT, NVB calculation points were determined according to previously published anatomic descriptions. Bilateral NVB points were considered to lie posterior-laterally, approximately 2 mm from the prostatic capsule. NVB doses were recorded bilaterally, at 0.5-cm intervals from the prostatic base. RESULTS: For Pd-103, the average NVB doses ranged from 150 Gy to 260 Gy, or 130% to 226% of the prescription dose. For I-125, the average NVB dose ranged from 200 Gy to 325 Gy, or 140% to 225% of the prescription dose. These was no consistent relationship between the NVB dose and the distance from the prostatic base. To examine the possible effect of minor deviations of our calculation points from the true NVB location, we performed NVB calculations at points 2 mm medial or lateral from the NVB calculation point in 8 patients. Doses at these alternate calculation points were comparable, although there was greater variability with small changes in the calculation point if sources were located outside the capsule, near the NVB calculation point. Three patients who developed early postimplant impotence had maximal NVB doses that far exceeded the average values. CONCLUSIONS: In the next few years, we hope to clarify the role of high NVB radiation doses on potency, by correlating NVB dose calculations with a large number of patients enrolled in an ongoing I-125 versus Pd-103 trial for early-stage patients, for whom detailed dosimetric and potency data are being collected prospectively. In the future, we anticipate that NVB doses may be incorporated into dosimetry guidelines to maximize tumor control and minimize treatment-related morbidity.

Prostate brachytherapy in patients with prior evidence of prostatitis.

PURPOSE: To refute a misconception that a prior history of prostatitis is a contraindication to prostate brachytherapy. METHODS AND MATERIALS: Five patients with clinical or pathologic evidence of prior prostatitis were treated with transperineal brachytherapy. Four of the patients received a single i.v. dose of ciprofloxacin (500 mg) intraoperatively. Postimplant antibiotics were not given. The pretreatment biopsy slides were reviewed. RESULTS: Two of the five patients developed postimplant urinary retention requiring short-term catheterization, and both resolved spontaneously. One patient developed what appeared to be an exacerbation of his chronic prostatitis. CONCLUSION: We continue to recommend prostate brachytherapy for the treatment of clinically organ-confined cancer, with no concern about prior clinical or pathologic evidence of prostatitis.

Radiation safety parameters following prostate brachytherapy.

PURPOSE: To determine the degree and variability of radiation exposure to the general public from patients after I-125 or Pd-103 prostate brachytherapy. METHODS AND MATERIALS: Radiation exposure measurements were made from 38 consecutive, unselected patients with stage T1 or T2 prostatic carcinoma who had transperineal I-125 or Pd-103 implants at the University of Washington in 1998. RESULTS: The exposure rate at the anterior skin surface following a I-125 implant ranged from 2.2 to 8.9 mrem/hour (average: 5.0). The exposure rate at the anterior skin surface from a Pd-103 implant ranged from 0.5 to 4.9 mrem/hour (average: 1.7). Based on the current Nuclear Regulatory Commission (NRC) regulations the time required to reach the annual limit at the anterior skin surface would be 20 hours for I-125 and 59 hours for Pd-103. For exposure at the lateral skin surface, the times would exceed 500 hours for either isotope. CONCLUSIONS: This data suggest that patients need not be concerned about being a radiation risk to the general public following their procedure.

Local anesthesia for prostate brachytherapy.

PURPOSE: To demonstrate the technique and feasibility of prostate brachytherapy performed with local anesthesia only. METHODS AND MATERIALS: A 5 by 5 cm patch of perineal skin and subcutaneous tissue is anesthetized by local infiltration of 10 cc of 1% lidocaine with epinephrine, using a 25-gauge 5/8-inch needle. Immediately following injection into the subcutaneous tissues, the deeper tissues, including the pelvic floor and prostate apex, are anesthetized by injecting 15 cc lidocaine solution with approximately 8 passes of a 20-gauge 1.0-inch needle. Following subcutaneous and peri-apical lidocaine injections, the patient is brought to the simulator suite and placed in leg stirrups. The transrectal ultrasound (TRUS) probe is positioned to reproduce the planning images and a 3.5- or 6.0-inch, 22-gauge spinal needle is inserted into the peripheral planned needle tracks, monitored by TRUS. When the tips of the needles reach the prostatic base, about 1 cc of lidocaine solution is injected in the intraprostatic track, as the needle is slowly withdrawn, for a total volume of 15 cc. The implants are done with a Mick Applicator, inserting and loading groups of two to four needles, so that a maximum of only about four needles are in the patient at any one time. During the implant procedure, an additional 1 cc of lidocaine solution is injected into one or more needle tracks if the patient experiences substantial discomfort. The total dose of lidocaine is generally limited to 500 mg (50 ml of 1% solution). RESULTS: To date, we have implanted approximately 50 patients in our simulator suite, using local anesthesia. Patients' heart rate and diastolic blood pressure usually showed moderate changes, consistent with some discomfort. The time from first subcutaneous injection and completion of the source insertion ranged from 35 to 90 minutes. Serum lidocaine levels were below or at the low range of therapeutic. There has been only one instance of acute urinary retention in the patients treated so far, and no unplanned admissions to the hospital or need to reschedule a patient to be implanted under general or spinal anesthesia. CONCLUSIONS: The substitution of local anesthesia has facilitated rapid introduction of a high-volume brachytherapy program at an institution that previously had none, without requiring the allocation of significant operating room time. Although the patients reported here were implanted without conscious sedation, we are starting to try various sedatives and analgesics for patients who we anticipate will have substantial anxiety with the procedure.

Anticipating prostatic volume changes due to prostate brachytherapy.

The purpose of the study was to determine which clinical parameters might predict individual prostate volume changes from prostate brachytherapy. Fifty consecutive, unselected patients treated at the University of Washington by I-125 or Pd-103 implantation for prostatic carcinoma in 1998 were analyzed. The prostate contours on preimplant transrectal ultrasound (TRUS) images were digitized and the prostate volumes calculated. Postimplant axial CT images of the prostate was obtained at 0.5 cm intervals with patients in the supine position the morning after the implant. The postimplant prostate volume increased by an average factor of 1.7 (+/-0.34) compared with the preimplant volume, the size increase being primarily in the anterior-posterior dimension. The absolute volume change was similar in patients with small vs. large preimplant prostate volume (r = -0.39), but the proportional change was less in patients with a larger prostate volume (r = -0.71). Because patients with a small preimplant prostate had proportionately greater volume increase, their postimplant target coverage was generally less. No single parameter, including preimplant prostate volume, preimplant hormonal deprivation, or supplemental external beam radiation therapy (EBRT) can accurately predict the degree of swelling. The precise significance of and practical solution to implant-related prostate volume changes remains to be determined.

Optimization of intensity modulated beams with volume constraints using two methods: cost function minimization and projections onto convex sets.

For accurate prediction of normal tissue tolerance, it is important that the volumetric information of dose distribution be considered. However, in dosimetric optimization of intensity modulated beams, the dose-volume factor is usually neglected. In this paper we describe two methods of volume-dependent optimization for intensity modulated beams such as those generated by computer-controlled multileaf collimators. The first method uses a volume sensitive penalty function in which fast simulated annealing is used for cost function minimization (CFM). The second technique is based on the theory of projections onto convex sets (POCS) in which the dose-volume constraint is replaced by a limit on integral dose. The ability of the methods to respect the dose-volume relationship was demonstrated by using a prostate example involving partial volume constraints to the bladder and the rectum. The volume sensitive penalty function used in the CFM method can be easily adopted by existing optimization programs. The convex projection method can find solutions in much shorter time with minimal user interaction.