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Genitourinary Imaging |
1 From the Scott Department of Urology, Baylor College of Medicine and the Methodist Hospital, 6560 Fannin, Ste 2100, Houston, TX 77030. Received August 11, 1999; revision requested September 29; final revision received September 11, 2000; accepted October 2. Address correspondence to K.M.S. (e-mail: kslawin@bcm.tmc.edu).
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMATERIALS AND METHODS RESULTSDISCUSSIONREFERENCES |
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MATERIALS AND METHODS: Ninety-nine patients with biochemical recurrence after radical prostatectomy were evaluated at transrectal US and prostatic fossa biopsy. Location of suspected recurrence at transrectal US and clinical features, such as prostate-specific antigen levels and digital rectal examination findings, were correlated with biopsy results.
RESULTS: Forty-one (41%) of 99 cases of local recurrence were detected. The percentage of sites of lesions identified at transrectal US and corresponding positive biopsy rates were as follows: the urethrovesical anastomotic area, 56% and 61%; bladder neck, 26% and 54%; retrovesical space, 4% and 100%; and more than one site, 14% and 71%. By comparing transrectal US and digital rectal examination, the sensitivities were 76% and 44% (P = .007), while specificities were 67% and 91% (P = .004), respectively. An increased positive biopsy rate with increasing prostate-specific antigen levels was noted (P = .04).
CONCLUSION: Transrectal US is more sensitive but less specific than digital rectal examination in the detection of local recurrence. Biopsy findings in more than half of the suspected lesions at the urethrovesical anastomotic area and bladder neck were positive. Lesions in the retrovesical space, although less frequently encountered, had a high likelihood of representing cancer recurrence.
Index terms: Genitourinary system, US, 844.1298, 844.12985, 844.12989 • Prostate, biopsy, 844.1261 • Prostate neoplasms, US, 844.32 • Ultrasound (US), guidance, 844.12985, 844.12989
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODS RESULTSDISCUSSIONREFERENCES |
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It is clinically important to distinguish patients who have locally recurrent disease in the prostatic fossa alone from those with occult metastatic disease. Patients with only local recurrence may benefit from locally administered radiation therapy that may be curative in 48%–56% of properly selected patients (15,16). Furthermore, patients who have occult metastatic disease could avoid the morbidity and cost of salvage radiation therapy.
Current methods used to distinguish these two types of recurrence include diagnostic modalities—such as digital rectal examination (DRE), nuclear bone scanning, transrectal ultrasonography (US) of the prostatic fossa, computed tomography (CT), magnetic resonance (MR) imaging, monoclonal antibody scanning, and positron emission tomography (PET)—as well as clinical parameters—such as interval from radical prostatectomy to PSA recurrence, postoperative PSA velocity (14), or postoperative PSA level doubling time (17).
Researchers in a recent study (18) have reported that transrectal US of the prostatic fossa, either alone or in combination with US-guided biopsy of the prostatic fossa, is frequently recommended for patients who have a detectable serum PSA level after radical prostatectomy. However, some investigators have questioned the clinical usefulness of both transrectal US and prostatic fossa biopsy, suggesting that transrectal US and prostatic fossa biopsy should be performed only in patients without clinical evidence of distant disease who present with a new palpable abnormality (19).
The characteristics of the appearance of a normal urethrovesical anastomosis, as well as the patterns of local recurrence after radical prostatectomy, have been described elsewhere (20–24). However, to our knowledge, the correlation of these features with the results of prostatic fossa biopsy have not been reported in a large series of patients. The purpose of this study was to determine the potential value of transrectal US in the diagnosis of local recurrence of prostate cancer at the prostatic fossa following radical prostatectomy by correlating the specific patterns of suspected local recurrences at transrectal US to the results of biopsy of the prostatic fossa and by comparing transrectal US with DRE.
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MATERIALS AND METHODS |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODS RESULTSDISCUSSIONREFERENCES |
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One hundred eighteen of the 224 patients were postoperatively followed up in other medical facilities, and for these patients, only postoperative serum PSA levels were available. One hundred six of the remaining patients were evaluated at our institution with transrectal US for evidence of local recurrence. Patients were excluded from this study if data from the medical records were insufficient (n = 2), if no biopsy of the anastomotic area was performed at the time of transrectal US (n = 2), if adjuvant external radiation or hormonal treatment was administered after radical prostatectomy but before the time of the evaluation (n = 2), or if a markedly elevated serum PSA value (>20 ng/mL) suggestive of a high likelihood of metastatic disease (25,26) was noted at the time of transrectal US (n = 1). The remaining 99 patients were included in this retrospective study. Mean patient age was 66.6 years (median, 67 years; SD, 6.26; age range, 53–83 years). All patients who underwent a radical prostatectomy were followed up postoperatively, with DRE and PSA level determinations every 3 months in the 1st year, every 6 months through the 5th year, and once a year after 5 years.
Methods
All patients, at the time of the evaluation, had a palpable abnormality in the area of the anastomosis, a sustained elevation in the serum PSA level, or both. DRE findings were considered abnormal if any mass, nodule, induration, or irregularity was noted in the prostatic fossa. Serum PSA levels were measured by using a radioimmunoassay (Tandem-R; Hybritech, San Diego, Calif), and a serum PSA value greater than 0.4 ng/mL and increasing was considered a sustained elevation. All patients had a bone scan that was negative for metastatic disease at the time of evaluation.
Gray-scale transrectal US was performed by using an 1846 model machine with a model 8551 7.5-MHz side-fire biplane probe (Brüel & Kjær, Nærum, Denmark) until 1994 and by using a Gateway 2D model with an ECLA/7.0MI/11 end-fire probe (Diasonics Vingmed Ultrasound, Santa Clara, Calif) or an EUB-525 machine with an EUP-V33W 6.5-MHz end-fire probe (Hitachi Medical Systems, Tarrytown, NY) thereafter. Color Doppler images were not obtained. Transrectal US examinations were performed by urologists specifically trained in transrectal US of the prostate. Standard antibiotic prophylaxis included 500 mg of ciprofloxacin hydrochloride (Cipro; Bayer, West Haven, Conn) administered orally to the patients on the night before and the morning of the biopsy procedure and was continued for 2 additional days. Patients were positioned on the examining table in the left lateral decubitus position. All studies were performed by specially trained urologists, who followed a standard pattern of examination and used the same criteria in the interpretation of the prostatic fossa images.
Transrectal US findings were considered to be suggestive of local recurrence if any lesion was identified at or around the area of the anastomosis, at the bladder neck, or in the retrovesical space or if any asymmetry or obvious distortion of the urethrovesical anastomosis was noted. No grading scale of the severity of the findings that were considered suggestive of local recurrence was used.
Biopsy cores were obtained by using an 18-gauge needle with a biopsy gun (Biopty; Bard Urological, Uppsala, Sweden) until 1994 and with a spring-loaded gun (ProMag 2.2; Manan Medical Systems, Northbrook, Ill) thereafter. Biopsy strategies varied according to the specific clinical findings in each patient. Patients with no visible abnormalities at transrectal US and no palpable abnormalities at DRE underwent random guided biopsy of the prostatic fossa that usually included removal of two cores from either side of the anastomosis, one toward the bladder neck and one toward the external urethral sphincter (Fig 1) or, rarely, one core from each side lateral to the anastomosis. Patients with palpable abnormalities at DRE and no evident abnormality at transrectal US underwent digitally guided biopsy and additional random biopsy, as described previously. Patients with palpable and visible abnormalities underwent transrectal US–guided biopsy of the abnormal area, with additional random biopsy if the visible or palpable abnormality was beyond the range of random biopsy. Repeat biopsy in some patients with initial negative prostatic fossa biopsy findings was performed at the discretion of the treating physician.
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Statistical analysis of the results was performed by using INTERCOOLED 5.0 STATA (Stata, College Station, Tex). A P value of .05 or less was considered to indicate a statistically significant difference. The Pearson 
2 test or the Fisher exact test was used to compare differences in the detection of local recurrence according to the results of transrectal US, the results of DRE, and the location of suggestive findings at transrectal US. Sensitivity and specificity with corresponding 95% CIs for transrectal US and DRE were calculated and tested with the McNemar test. The Mann-Whitney U test was used to compare PSA values and intervals, according to biopsy results. Differences in the serum PSA values with respect to the number of biopsies were tested by using the Kruskal-Wallis test. The Mantel-Haenszel 2 test was used to compare rates of detection of local recurrence among various PSA level ranges.
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RESULTS |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODS RESULTSDISCUSSIONREFERENCES |
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The results of the prostatic fossa biopsy in relation to the findings at transrectal US and DRE are presented in Table 1. Findings at transrectal US of the prostatic fossa were normal in 49 (49%) patients, revealing a smooth tapered bladder neck and symmetric urethrovesical anastomosis, with no mass lesions at the bladder neck, urethrovesical anastomosis, or retrovesical space (Fig 2). In the majority of these patients, 39 (80%) of 49, prostatic fossa biopsy failed to demonstrate the presence of local recurrence. However, in 50 (51%) patients, transrectal US showed a lesion suggestive of local recurrence, and 31 (62%) of these patients had a positive finding at biopsy of the prostatic fossa. DRE did not reveal any palpable abnormalities in 76 (77%) patients, and 53 (70%) of these patients had negative findings at prostatic fossa biopsy. Twenty-three (23%) patients had abnormal DRE results, and 18 (78%) of these had biopsy-proved local recurrence.
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Diagnostic indexes, as well as corresponding 95% CIs, were calculated for both tests and are presented in Table 2. Transrectal US proved more sensitive than DRE (76% vs 44%; 95% CI: 60%, 88% vs 29%, 60%; P = .007), and, conversely, DRE proved more specific than transrectal US (91% vs 67%; 95% CI: 81%, 97% vs 54%, 79%; P = .004) in the detection of local recurrence of prostate cancer. Positive predictive values were 62% (95% CI: 47%, 75%) and 78% (95% CI: 56%, 93%), and negative predictive values were 80% (95% CI: 66%, 90%) and 70% (95% CI: 58%, 80%) for transrectal US and DRE, respectively.
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODS RESULTSDISCUSSIONREFERENCES |
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Evaluation of patients in whom a serum PSA level becomes detectable after radical prostatectomy still presents a quandary for the physician. A variety of diagnostic tests—including bone scanning, transrectal US and prostatic fossa biopsy, CT of the abdomen and pelvis, MR imaging of the prostatic fossa, or PET—may be performed in this clinical scenario. Transrectal US of the prostatic fossa in patients with no clinical or biochemical evidence of recurrence after radical prostatectomy typically shows a slitlike tapered profile from the bladder neck to the urethrovesical anastomosis, which is surrounded by a variable amount of tissue that is more prominent anteriorly and that is hypoechoic relative to the surrounding fat (20,28,29). Other than an obvious hypoechoic lesion in the perianastomotic area, bladder neck, or retrovesical space, criteria suggested (21–23,30–32) for the transrectal US appearance of local recurrence of prostate cancer include asymmetric thickening or fullness of the anastomosis and loss of the integrity of the retroanastomotic fat plane.
In our study, the majority of suspected lesions at transrectal US were hypoechoic in relation to the surrounding tissues and had specific patterns of distribution within the prostatic fossa. The reported (23,30–34) incidence of abnormal transrectal US findings in patients suspected of having a local recurrence after radical prostatectomy ranges from 49% to 95%. In our study, only 49% of the patients evaluated for local recurrence had a suspected lesion at transrectal US, whereas in other studies, a higher incidence has been reported. While we found a lower incidence of detected lesions at transrectal US, we also found lower sensitivity but higher specificity values for transrectal US than other investigators did. Connolly et al (24) reported sensitivity and specificity values for transrectal US of 91.9% and 29.1%.
The discrepancy in the diagnostic indexes for transrectal US between our study and other reported studies may reflect underlying differences within the studied populations, but it may also be because of subjective differences in the criteria used to classify lesions as suggestive of a local recurrence. Unlike those in other studies, our patients underwent surgery at a single institution, performed by a limited number of surgeons who used a standard surgical technique for radical prostatectomy. Because a standard surgical technique was followed, a uniform postoperative appearance of the prostatic fossa at transrectal US was typically seen. Our criterion for the determination of a suspected lesion at the prostatic fossa was limited to the identification of a discrete mass at the prostatic fossa or of an obvious asymmetry of the urethrovesical anastomosis, and this may account for the lower sensitivity reported in our study.
Lesions suggestive of local recurrence at transrectal US were found most frequently in the perianastomotic area (56%), a finding consistent with that of other studies (24). More than half (61%) of these patients had positive prostatic fossa biopsy findings, and in approximately 50% of them, the lesion was also palpable. The area of the bladder neck was the second most common site of lesions (26%), with a positive biopsy finding in 54% of the patients but a palpable finding at DRE in only 17%. Thus, for the detection of a local recurrence at the area of the bladder neck, transrectal US provides a substantial advantage compared with DRE, since lesions in that area may be more difficult to appreciate at DRE, possibly because of an anterior location or because of merging of the lesion with the bladder wall.
Lesions that occupied more than one site within the prostatic fossa had a greater likelihood (71%) of having positive biopsy findings, and the lesions were more likely to be palpable compared with those that occupied one site. In our series, all patients with a combination of an abnormal DRE finding and a suggestive transrectal US finding had a positive prostatic fossa biopsy finding, and in 69% of these patients, a diagnosis was made at the initial biopsy, as opposed to 13% of the patients who had normal DRE and transrectal US findings but had positive biopsy findings. The inability of prostatic fossa biopsy to reveal local recurrence in a patient with normal DRE and transrectal US findings may reflect the fact that either the local disease burden might be too small to be detected at biopsy or the biochemical recurrence might be due to clinically occult micrometastatic disease.
In our study population, initial biopsy yielded a positive finding rate of 30%, while findings in 55% of subsequent repeat biopsies were positive, for an overall detection rate of 41%. The reported detection rates in other studies range from 45% to 53% for studies that include a single biopsy (30,31) and from 51% to 55% for studies that include repeat prostatic fossa biopsy as well (23,24,32). Foster et al (23) reported that the first biopsy revealed local recurrence in 35% of their patients, while repeat biopsy findings were positive in 47%, resulting in an overall detection rate of 51%. In a subsequent larger series (24) from the same institution, investigators reported an overall detection rate of 54%. Saleem et al (32) reported an overall detection rate of 55%, with corresponding rates at first, second, third, and fourth biopsy of 35%, 44%, 40%, and 33%, respectively. Differences in the detection rates may be attributed to differences in the biopsy strategies, as well as to differences between the patient populations studied.
Our biopsy strategy included a rather extensive number of biopsies per patient in an effort to minimize the effect of sampling error in the detection of local recurrence. Although the optimal prostatic fossa biopsy strategy regarding location and number of cores has not been proved, our experience suggests that increasing the core number will not markedly improve the detection rate of local recurrence. Furthermore, inclusion of midline biopsy of the prostatic fossa, although technically feasible, might expose the patient to increased discomfort and morbidity, with complications such as urethral bleeding.
The clinical importance and utility of confirming local recurrence with prostatic fossa biopsy is controversial. While some investigators (35) suggest a benefit, others (36–39) have failed to confirm a marked difference in the response to salvage radiation therapy in patients with biopsy-proved local recurrence compared with patients with only biochemical recurrence. Serum PSA level prior to initiation of salvage radiation therapy has been recognized as a predictor of a favorable response, with the most favorable response seen in patients who are treated when the PSA level is low, within the range of 1.0–2.7 ng/mL (37,38,40–46). Therefore, the performance of any diagnostic test for the detection of local recurrence of prostate cancer should be evaluated within the subset of patients who present when the postoperative PSA value is less than 2.0 ng/mL, rather than within the entire spectrum of patients. Diagnostic modalities, such as DRE, transrectal US, and prostatic fossa biopsy, provide a limited detection rate that is directly related to the tumor burden at the prostatic fossa, as reflected by the serum PSA level.
Our results show that in patients with a low serum PSA level (<2.0 ng/mL), prostatic fossa biopsy, given the limitations of the inherent biopsy sampling error, yielded a detection rate that was approximately 30%, but the sensitivity and specificity of DRE and transrectal US were not significantly different from those of the overall population (Table 2). When we consider the fact that a low serum PSA level before irradiation is correlated with a favorable response to salvage radiation therapy, delaying therapy until repeat prostatic fossa biopsy reveals local recurrence (32) would be at the expense of a higher response rate to salvage radiation therapy.
Other diagnostic modalities that have been used for the detection of local recurrence after radical prostatectomy include color Doppler transrectal US, CT, MR imaging, radioactively labeled monoclonal antibody scanning, and PET. Color Doppler US has been reported (47) to increase the sensitivity and specificity of gray-scale transrectal US by facilitating the identification of hypervascular areas within the prostatic fossa and by guiding biopsy in that area. CT has limited value in the detection of local recurrence mainly because the distinction of postoperative scar tissue from soft tissue is particularly difficult, especially in the absence of contrast medium uptake. Furthermore, CT is incapable of depiction of lesions smaller than 2 cm in diameter (48,49).
Transrectal surface coil MR imaging is a reasonable alternative modality for use in the detection of local recurrence, with most lesions appearing as hyperintense structures, especially following the injection of a gadolinium-based contrast agent. Silverman and Krebs (50) have reported on the diagnostic indexes of MR imaging in the detection of local recurrence after radical prostatectomy in a patient population with a mean postoperative serum PSA value of 1.4 ng/mL. In that study, confirmation of the MR imaging results was performed by using prostatic fossa biopsy, and all of the patients who had a positive MR imaging finding also had biopsy-confirmed local recurrence. Sensitivity and specificity of the test were calculated at 100%. However, these high values have yet to be confirmed by findings in other studies.
Recently, a radioactively labeled monoclonal antibody, indium 111 (111In) capromab pendetide, has been used in the evaluation of patients in whom primary treatment of prostate cancer fails. Studies (51–54) with this modality show promising results in the detection of prostate cancer recurrence in both the prostatic fossa and lymph nodes. Burgers et al (51) reported sensitivity and specificity values of 94% and 65%, respectively, for the test in the detection of local recurrence in the prostatic fossa after radical prostatectomy. Recently, in a multi-institutional study, Kahn et al (54), using 111In capromab pendetide testing in patients with biochemical recurrence after radical prostatectomy and a median postoperative PSA level of 2.6 ng/mL, reported sensitivity and specificity values of 49% and 71%, respectively, for the detection of local recurrence at the prostatic fossa that are comparable to those of transrectal US and prostatic fossa biopsy.
In addition to the clinical utility of the scan for the detection of local recurrence, some investigators (55) have suggested that a negative scan or a scan positive in only the prostatic fossa is an important predictor of a favorable response to salvage radiation therapy. However, inherent difficulties in the interpretation of a scan due to radioactivity from structures adjacent to the prostatic fossa, such as the pubic bone and the rectum, may result in false-positive results (54), while inadequate blood flow, low PSA membrane antigen concentration, or low tumor volume in the prostatic fossa that is undetectable with the current gamma cameras may result in false-negative results (54).
PET is being evaluated in patients in whom primary local therapy for prostate cancer has failed. Preliminary data show that although PET may be more sensitive than CT for the detection of lymph node metastasis, bladder activity poses a serious problem in the identification of local prostate cancer recurrence (56).
In conclusion, transrectal US is more sensitive but less specific than DRE in the detection of biopsy-proved local recurrence after radical prostatectomy. The perianastomotic and bladder neck areas were the sites most frequently suspected of harboring a local recurrence at transrectal US (more than half of the suspected lesions located in those areas had positive findings at prostatic fossa biopsy), while lesions located in the retrovesical space, although less frequently encountered, had a high likelihood of representing prostate cancer recurrence.
Whether MR imaging, 111In capromab pendetide testing, or PET will have a greater role in the evaluation and clinical decision making in patients in whom radical prostatectomy has failed remains to be determined. Further studies are needed to evaluate the performance of these modalities in the patient population most likely to benefit from salvage treatment, namely those with a low postoperative PSA value. In addition, studies of the cost-effectiveness of these modalities must be performed before they are routinely adapted in clinical practice. Transrectal US and prostatic fossa biopsy currently remain the most efficient and cost-effective tools in the detection of local recurrence after radical prostatectomy. They provide a reasonable detection rate of local recurrence and are readily available in clinical practice. On the other hand, transrectal US and prostatic fossa biopsy present limitations in the detection of local recurrence after radical prostatectomy that include the subjectivity in the interpretation of the prostatic fossa images and the inability of transrectal US to depict a difference between prostate cancer recurrence and postoperative scar tissue. However, the inability of transrectal US and prostatic fossa biopsy to aid in the detection of a minimal tumor burden is the most serious limitation. Clinical parameters such as PSA level and PSA doubling time may, in the end, prove to be more useful than transrectal US or prostatic biopsy in the prediction of local recurrence and in the selection of appropriate patients for salvage radiation therapy (57).
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ACKNOWLEDGMENTS |
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FOOTNOTES |
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Author contributions: Guarantors of integrity of entire study, K.M.S., A.K.L.; study concepts and design, K.M.S., A.K.L.; literature research, A.K.L., S.F.S.; clinical studies, A.K.L., S.F.S.; data acquisition, A.K.L., S.F.S.; data analysis, A.K.L., K.M.S.; statistical analysis, A.K.L.; manuscript preparation, A.K.L., S.F.S.; manuscript editing, K.M.S., A.K.L., S.F.S.; manuscript review and final version approval, K.M.S.
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REFERENCES |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODS RESULTSDISCUSSIONREFERENCES |
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