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M S Soloway

Publications and source records attributed to M S Soloway.

At least 37 records · Page 2Linked to original sources

Urinary hyaluronic acid and hyaluronidase: markers for bladder cancer detection and evaluation of grade.

PURPOSE: Specific patterns of progression and frequent recurrence of bladder tumors determine the choice of treatment, frequency of surveillance, quality of life, and ultimately, patient prognosis. The prognosis would be improved if an accurate noninvasive test was available for diagnosis. Identification of markers that function in bladder cancer progression would be helpful in designing such diagnostic tests. The glycosaminoglycan, hyaluronic acid (HA), promotes tumor metastasis. Hyaluronidase (HAase), an endoglycosidase, degrades HA into small fragments that promote angiogenesis. We have previously shown that both HA and HAase are associated with bladder cancer and may function in bladder tumor angiogenesis. In this study we examined whether urinary HA and HAase levels serve as bladder cancer markers. MATERIALS AND METHODS: Among the 513 urine specimens analyzed, 261 were from transitional cell carcinoma (TCC) patients, 9 from patients with non-TCC tumors, and 243 from controls (normals, patients with other genitourinary (GU) conditions or a history of bladder cancer (HxBCa)). The urinary HA and HAase levels were measured by two ELISA-like assays that utilize a biotinylated HA binding protein for detection. These levels were normalized to total urinary protein and were expressed as ng./mg. (HA test) and mU/mg. (HAase test), respectively. RESULTS: The urinary HA levels were elevated (2.5 to 6.5 fold) in bladder cancer patients (1173.7+/-173.4; n = 261) as compared with normals (246.1+/-38.5; n = 41); GU patients (306.6+/-32.2; n = 133), and patients with a HxBCa (351.1+/-49.1; n = 69) (p <0.001). The urinary HAase levels were elevated (3 to 7 fold) in G2/G3 bladder cancer patients (26.2+/-3.2) as compared with normals (4.5+/-0.9) and patients with either GU conditions (5.8+/-1.3), HxBCa (8.2+/-2.6) or G1 tumors (9.7+/-2.5) (p <0.001). The HA test showed 83.1% sensitivity, 90.1% specificity and 86.5% accuracy in detecting bladder cancer, regardless of the tumor grade. The HAase test showed 81.5% sensitivity, 83.8% specificity and 82.9% accuracy to detect G2/G3 patients. Combining the inferences of the HA and HAase tests (HA-HAase test) resulted in detection of bladder cancer, regardless of tumor grade and stage, with higher sensitivity (91.2%) and accuracy (88.3%), and comparable specificity (84.4%). CONCLUSION: Our results show that the HA-HAase urine test is a noninvasive, highly sensitive and specific method for detecting bladder cancer and evaluating its grade.

Adult↗

Deferred treatment of localized prostate cancer in the elderly: the impact of the age and stage at the time of diagnosis on the treatment decision.

OBJECTIVE: To assess the clinical behaviour of clinically localized prostate cancer in elderly patients monitored until progression, and the impact of clinical variables, i.e. clinical stage, Gleason score, the dynamics of prostate specific antigen (PSA) and age, on the natural history of the disease. PATIENTS AND METHODS: Between February 1991 and January 1998, 54 patients (mean age 76.4 years, median 77 at the time of diagnosis) with clinically localized prostate cancer who elected for watchful waiting were identified. They were monitored regularly and treatment deferred until progression. Progression was defined as local stage progression (as assessed on a digital rectal examination), biochemical progression or metastasis. All patients who progressed were offered either radiation therapy or hormonal treatment. Each clinical variable was assessed by univariate and multivariate analysis to predict disease progression. The mean follow-up was 47 months. RESULTS: Of the 54 patients, 28 (52%) progressed; 10 had biochemical, 11 local and four biochemical and local progression, and three developed metastasis. All the patients who progressed elected to receive hormonal treatment. The mean time to progression was 35 months. Gleason score (</= 6 and > 6), age (</= 75 and > 75 years) and serum PSA level (</= 10 and > 10 ng/mL) were statistically significant predictors of disease progression (P = 0.04, < 0.001 and 0.02, respectively). The clinical stage at the time of diagnosis had a borderline effect on disease progression (P = 0.06). On multivariate analysis, Gleason score and PSA level were statistically significant predictors of disease progression. CONCLUSION: These results suggest that the treatment of prostate cancer should not be deferred in patients aged > 75 years with a good performance status when the biopsy has a Gleason score >/= 6 and the serum PSA level is >/= 10 ng/mL.

Age Factors↗

Safety and efficacy of an implantable leuprolide delivery system in patients with advanced prostate cancer.

PURPOSE: We evaluated the pharmacokinetics, safety and efficacy of the implantable Viadur++ leuprolide delivery system during 12 months in patients with advanced prostate cancer. MATERIALS AND METHODS: Our open label, multicenter, dose ranging study was done in 2 phases. The treatment phase was a stratified, randomized, parallel evaluation of the safety and efficacy of 1 or 2 implants. The safety extension phase assessed the long-term safety and efficacy of 1 implant. Implant insertion and removal, pharmacokinetic profile and patient satisfaction were also evaluated. The primary efficacy parameter was testosterone suppression for 12 months but luteinizing hormone and prostate specific antigen were also evaluated. RESULTS: Of the 51 patients 27 received 1 and 24 received 2 implants, of whom 49 completed the 12-month treatment phase. Steady serum leuprolide concentration was maintained from day 3 through the remainder of the 12-month treatment phase and for 2 months after reimplantation. Implantation and reimplantation were well tolerated and acceptable to physicians and patients. Testosterone suppression to the castrate range was 100% in each group. At 12 months mean prostate specific antigen decreased from a baseline of approximately 84% and 91% in groups 1 and 2, respectively. Serious adverse events during the study period in 15 patients were not attributable to treatment. CONCLUSIONS: The implantable leuprolide delivery system provides effective suppression of testosterone in patients with advanced prostate cancer.

Aged↗

Periprostatic local anesthesia before ultrasound guided prostate biopsy.

PURPOSE: We assessed the morbidity and benefit of periprostatic local anesthesia administered before ultrasound guided prostate biopsy. MATERIALS AND METHODS: After placing the transrectal ultrasound probe and visualizing the prostate 50 consecutive patients received local anesthesia before prostate biopsies. RESULTS: There was no morbidity associated with the infiltration of local anesthesia into the periprostatic neurovascular plexus. Only 1 patient had discomfort during prostate biopsies, and 10 patients who previously underwent biopsies without anesthesia commented favorably on the dramatic difference. CONCLUSIONS: Many patients have pain during transrectal ultrasound guided biopsies of the prostate and few clinicians provide a periprostatic nerve block before this procedure. A periprostatic nerve block administered before the biopsies dramatically decreases discomfort. We urge all urologists to attempt this procedure, and we are confident that they will adopt it as part of their practice.

Anesthesia, Local↗

Bladder-neck preservation during radical retropubic prostatectomy.

The goal of the urologic surgeon performing total prostatectomy for prostate cancer is to eliminate the cancer and minimize the side effects associated with treatment. We believe that careful dissection of the prostate from the bladder can be performed in such a manner as to preserve most of the circular fibers of the bladder neck. This so-called bladder-neck preservation technique appears to reduce the risk of an anastomotic stricture and accelerate the return of urinary continence. An analysis of 676 consecutive prostatectomies revealed that 4.3% of the men had tumor touching the inked bladder neck margin. Only 1% had this as the only positive margin. Most of these patients had a preoperative prostate-specific antigen > 10 and a Gleason score of 7 or greater suggesting that bladder-neck preservation did not compromise the outcome of surgery. A more extensive resection of the bladder neck is not likely to be curative.

Aged↗

The use of video-based patient education for shared decision-making in the treatment of prostate cancer.

Increased consumerism, patient empowerment, and autonomy are creating a health care revolution. In recent years, the public has become better informed and more sophisticated. An extraordinary amount of treatment advice from books, the media, and the Internet is available to patients today, although much of it is confusing or conflicting. Consequently, the traditional, paternalistic doctor-patient relationship is yielding to a more consumerist one. The new dynamic is based on a participatory ethic and a change in the balance of power. This shared decision-making creates a true partnership between professionals and patients, in which each contributes equally to decisions about treatment or care. Evidence suggests that in diseases such as prostate cancer, where there may be a number of appropriate treatment options for a particular patient, shared decision-making may lead to improved clinical and quality-of-life outcomes. This article explores the evolving relationship between the physician and patient, the pros and cons of shared decision-making, and the use of video technology in the clinical setting. The authors review the use of medical decision aids, including a video-based educational program called CHOICES, in the treatment of prostate cancer and other diseases.

Decision Making↗

Salvage radical prostatectomy for radiorecurrent prostate cancer: morbidity revisited.

PURPOSE: With the advent of prostate specific antigen (PSA) testing and transrectal ultrasound guided prostate biopsy there has been stage migration in the diagnosis of prostate cancer, so that more younger men are being diagnosed with organ confined prostate cancer. Many patients elect radiation therapy, while some have recurrent or new prostate cancer with absent systemic disease and life expectancy greater than 10 years. We present our experience with salvage radical prostatectomy in these cases. MATERIALS AND METHODS: Between 1995 and 2000, 6 men treated with curative intent with radiotherapy for prostate cancer were subsequently treated with salvage surgery for clinically localized prostate cancer. All men had biopsy proved recurrent or persistent prostate cancer, increasing serum PSA, no evidence of systemic disease at surgery and life expectancy greater than 10 years. We assessed the morbidity associated with this procedure and compared results to those in the contemporary literature. RESULTS: Six patients underwent salvage radical prostatectomy. Initial pre-radiation PSA was 4.5 to 15.7 ng./ml. Pre-radiation disease was clinical stage T1c in 5 cases and B2 in 1. The interval from radiotherapy to repeat biopsy was 12 to 48 months. A mean of 6.3 months after local recurrence was detected and before salvage radical prostatectomy was performed 4 patients underwent androgen deprivation therapy. Mean operative time was 195 minutes, intraoperative blood loss was 680 cc, and hospital stay and catheterization time were 3.2 and 13.8 days, respectively. There were no rectal injuries. All 6 patients are impotent, 5 are continent and 1 has mild stress incontinence. There was biochemical failure in 1 case 36 months after salvage radical prostatectomy and no evidence of recurrence in the remaining 5 at a mean followup of 27 months. CONCLUSIONS: Salvage radical prostatectomy is a technically challenging procedure. In the past it was associated with a high incidence of rectal injury, urinary incontinence and anastomotic stricture. The results of our relatively small series are encouraging and concur with those of recent studies that the morbidity of salvage radical prostatectomy is lower than previously reported. We believe that salvage radical prostatectomy may be considered a reasonable treatment option in appropriate patients with radiorecurrent prostate cancer.

Aged↗

Exploratory analysis on the effect of race on clinical outcome in patients with advanced prostate cancer receiving bicalutamide or flutamide, each in combination with LHRH analogues. The Casodex Combination Study Group.

BACKGROUND: Black race has been associated with a significantly increased risk of prostate cancer mortality. This exploratory analysis investigated the effect of race on the clinical outcome of combined androgen blockade (CAB). METHODS: Data for analysis were obtained from a double-blind, randomized, multicenter trial comparing CAB in the form of bicalutamide (50 mg once daily) or flutamide (250 mg three times daily) plus luteinizing hormone-releasing hormone analogs (LHRHa; goserelin acetate 3.6 mg, or leuprolide acetate 7.5 mg) in 813 patients with stage D(2) prostate cancer (median follow-up, 160 weeks). Patients were analyzed according to race (African American [AA], white, or other). The primary clinical events were disease progression and survival. RESULTS: Four hundred and four patients received bicalutamide/LHRHa and 409 received flutamide/LHRHa. Although treatment with bicalutamide/LHRHa resulted in slightly longer time to progression and survival time in white and AA males than treatment with flutamide/LHRHa, the differences between the treatment groups were not statistically significant. CONCLUSIONS: No marked effect of race on clinical outcome was observed regardless of antiandrogen, suggesting that similar treatment benefits are to be expected in either race.

Adenocarcinoma↗

Intravesical therapy for transitional cell carcinoma of the bladder: the community practice.

OBJECTIVES: To assess how the community urologist employs intravesical therapy in patients with transitional cell carcinoma (TCC) of the bladder because most data on intravesical therapy reflect the experience of major referral centers. METHODS: The medical records of 234 consecutive patients with TCC were reviewed. Sixty-nine patients received intravesical treatment before referral. The initial pathologic findings, the indication for treatment (eg, grade and stage, initial versus recurrent tumor), the schedule of intravesical therapy, and the drug selected for each course of treatment were assessed. RESULTS: A total of 1 39 courses of intravesical treatment were given to 69 patients; thus, the avarage number of courses was 2.02 per patient. The drug used was bacillus Calmette-Guerin (BCG) in 81 (58%), mitomycin C in 34 (24%), thiotepa in 16 (12%), Adriamycin in 4 (3%), and unknown in 4 (3%). Intravesical treatment was given after transurethral resection of the initial tumor in 33 patients; the initial pathologic finding was high grade (ie, grade 3 or carcinoma in situ) and/or Stage T1 in 22, TaG1-G2 in 9, and unknown in 2. One course of treatment was administered to 34 patients (49%) and two or more courses to 35 patients (51%). Eleven patients with TaG 1 -2 tumors were treated repetitively despite failure, with an average of 3.5 courses per patient; the drug used was BCG in 44%. Nineteen percent of patients received maintenance therapy. Intravesical therapy had to be discontinued in 10 patients because of side effects; 8 patients (12%) developed small contracted bladders and severe irritative symptoms, 3 required cystectomy despite the lack of bladder cancer. CONCLUSIONS: Intravesical therapy in community practice conforms with the generally accepted indications for high-grade and T1 disease. However, the use of BCG for low-grade TCC appears to be quite common. Repeated courses may result in significant side effects. We emphasize that excessive treatment should be avoided for low-grade, Ta lesions and BCG reserved for patients with TaG3, carcinoma in situ, or T1 TCC.

Administration, Intravesical↗

Age as a prognostic factor for disease recurrence after radical prostatectomy.

OBJECTIVES: To assess whether age has an impact on biochemical recurrence after radical prostatectomy for localized adenocarcinoma of the prostate. METHODS: Four hundred eighty-nine consecutive patients who underwent radical retropubic prostatectomy and did not have metastases to the lymph nodes were retrospectively analyzed. Disease recurrence was defined as a serum prostate-specific antigen greater than 0.2 ng/mL and rising on at least two postoperative measurements. Biochemical progression was compared in patients 70 years old or younger and older than age 70. The Kaplan-Meier estimator and Cox's proportional hazards model were employed to investigate the impact of age on time to recurrence. Neoadjuvant androgen deprivation was treated as a stratification variable in the Cox models. RESULTS: The mean follow-up was 25.4 +/- 20.8 months. The Gleason score and extent of cancer in the pathologic analyses of the prostatectomy specimen was not significantly different between the two groups. Biochemical recurrence was detected in 12% of patients 70 years old or younger and in 25% of those older than 70 (P = 0.01). In multivariate analyses, after adjusting for all prognostic factors, younger age (70 years or younger) was independently associated with a longer time to recurrence (P <0.02). CONCLUSIONS: Our results suggest that age per se may be an independent prognostic factor for disease recurrence after radical prostatectomy. This implies that patients 70 years old or younger are more likely to benefit from surgery. This information may be useful when counseling patients with clinically localized carcinoma of the prostate.

Adenocarcinoma↗

Positive surgical margins with radical retropubic prostatectomy: anatomic site-specific pathologic analysis and impact on prognosis.

OBJECTIVES: To correlate the extent and location of positive surgical margins after radical prostatectomy with disease progression. METHODS: Data on 495 patients who underwent radical prostatectomy by one surgeon were analyzed. All radical prostatectomy specimens were sectioned entirely using 2 to 3-mm step sections by one pathologist. One hundred fifty-one patients (30.5%) had one or more positive surgical margins and were subjected to further detailed analysis. Recurrence was defined as a serum prostate-specific antigen (PSA) level of 0.2 ng/mL and rising on at least two postoperative measurements. RESULTS: The mean follow-up was 25.3 months (range 3 to 73). The overall recurrence rate was 13.3%. Neoadjuvant hormonal treatment was given to 37 (25%) of those with a positive margin. Patients with positive surgical margins had a significantly higher incidence of recurrence compared with those with negative margins (27.8% versus 6.9%, P = 0.001). The recurrence rate for various locations was 29% apex/urethra, 30% posterior, 33% anterior, 36% lateral, 48% posterolateral, and 57% bladder neck. Time to recurrence was shorter in patients older than 70 years (P<0.055); with a preoperative PSA greater than 10 ng/mL (P<0.0001); with a biopsy Gleason score greater than 7 (P = 0.02); with a prostatectomy Gleason score greater than 7 (P<0.001); with seminal vesicle invasion (P = 0.0001); having more than 1 location of a positive margin (P = 0.002); or having a positive margin at the bladder neck (P = 0.0003) or the posterolateral surface of the prostate (P = 0.02) compared with other locations. Multivariate proportional hazards analyses indicated that age older than 70 (P = 0.005), a prostatectomy Gleason score of 7 (P = 0.015) or 8 to 10 (P = 0.003), and positive margin(s) at the bladder neck (P = 0.003) were independently associated with a shorter time to recurrence among patients with a positive margin. CONCLUSIONS: In our study, among patients with positive surgical margins, those with multiple positive margins, or a margin involving the bladder neck or the posterolateral surface of the specimen carried a higher risk of progression. A positive margin at the bladder neck appears to be the most significant adverse prognostic indicator. This information may help in decisions regarding additional therapy.

Adenocarcinoma↗

Complications of advanced prostate cancer.

Currently, there is a lot of focus directed toward discovering treatments for patients with hormone refractory prostate cancer (HRPC) that will lead to increased survival. Until such treatments emerge, palliation is important to ensure patients the highest possible quality of life. Most disabling among symptoms associated with disease progression are bone pain, bone fracture, urinary tract obstruction, spinal cord compression, coagulation disorders, anemia, and edema. Diverse treatments, such as radiation therapy, surgery, chemotherapy, and supportive measures, can improve the impact of these problems, although improved symptom control is needed in some areas.

Anemia↗

Endocrine effects, efficacy and tolerability of a 10.8-mg depot formulation of goserelin acetate administered every 13 weeks to patients with advanced prostate cancer.

OBJECTIVE: To determine the endocrine effects, efficacy and tolerability of a 10.8-mg depot formulation of Zoladextrade mark (goserelin acetate, Zeneca Pharmaceuticals, Wilmington, Delaware, USA), a luteinizing hormone-releasing hormone agonist analogue, when administration was extended from every 12 weeks to every 13 weeks in patients with advanced prostate cancer. PATIENTS AND METHODS: Between July 1995 and May 1996, 59 patients with either locally advanced (T3 or T4) or metastatic prostate cancer were enrolled in an open-label, multicentre trial. Primary efficacy endpoints were testosterone measurements, and assessments of prostate specific antigen (PSA) response, subjective and objective response. Quality of life (QoL) was a secondary efficacy endpoint. RESULTS: Mean testosterone concentrations decreased to < 0.3 microgram/L by week 4 and remained so for the duration of treatment. There were no statistically significant differences in mean testosterone levels between weeks 12 and 13, or weeks 25 and 26. Serum testosterone suppression was adequate in all 58 evaluable patients at week 13, and 51 of 52 (98%) patients at week 26. Of the 58 evaluable patients, 52 (90%) had a PSA response. A subjective response was recorded for six of 11 evaluable patients. Of 58 patients evaluable for objective response, 46 (79%) had a partial response, three (5%) had stable disease and nine (16%) had objective progression. Except for a significant (P=0.014) decrease in overall sexual interest, QoL was unchanged during therapy. The most common side-effects, regardless of causality, were hot flushes (67%), pain (31%) and pelvic pain (22%). Mild injection-site complaints occurred with only three of 221 (1.4%) depot injections. CONCLUSIONS: Zoladextrade mark 10.8-mg depot, administered every 13 weeks to patients with advanced prostatic cancer, is well tolerated, provides adequate suppression of serum testosterone and produces PSA, subjective and objective responses.

Aged↗

Is there a role for digital rectal examination in the followup of patients after radical prostatectomy?

PURPOSE: We determine the role of digital rectal examination in the followup of patients after radical prostatectomy. MATERIALS AND METHODS: We retrospectively analyzed data on 501 consecutive patients who underwent radical retropubic prostatectomy between 1992 and 1998, and were followed at the University of Miami. Patients were evaluated at 3 to 6-month intervals after surgery with serum prostate specific antigen (PSA) and digital rectal examination. Biochemical recurrence was defined as PSA greater than 0.2 ng./ml. and increasing on at least 2 consecutive measurements. Local recurrence, detected by an abnormal digital rectal examination, was defined as an induration or nodularity in the prostatic fossa. RESULTS: Mean followup plus or minus standard deviation was 25.4+/-20.8 months. Disease recurred in 72 patients (14.4%) and was biochemical in all. An abnormal digital rectal examination was noted in 4 patients, none of whom had an undetectable PSA at the time of a palpable abnormality. CONCLUSIONS: Our results suggest that an abnormal digital rectal examination after radical prostatectomy is always associated with a detectable PSA, which implies that performing a digital rectal examination in the absence of a detectable PSA may not be necessary.

Adenocarcinoma↗

The value of upper tract cytology after transurethral resection of bladder tumor in patients with bladder transitional cell cancer.

PURPOSE: Patients with transitional cell carcinoma of the bladder are at risk for concurrent or subsequent cancer of the upper tract. Traditionally disease is monitored by radiography (excretory or retrograde urography). Some elect to sample the upper tract by obtaining urine for cytology. Are the results meaningful when performed in a patient with bladder cancer? MATERIALS AND METHODS: We evaluated 27 consecutive patients with transitional cell cancer of the bladder (grade 1 to 3, Ta to T2) with bladder wash for cytology and cystoscopy as well as resection of visible tumor. A 5F ureteral catheter was positioned at each ureteral orifice, flushed with saline and passed into each renal pelvis. Urine was collected for cytology. RESULTS: Of 19 patients (68%) with high grade (grade 3) bladder cancer 13 had a positive bladder wash, including 6 (32%) with tumor cells detected in the urine from the upper tract. Of 8 patients (38%) with low grade (grade 1 to 2) transitional cell cancer 3 had a positive bladder wash and 2 (25%) had a positive upper tract cytology. All patients had a normal upper tract by excretory or retrograde urography. Ureteroscopy was not performed. CONCLUSIONS: Given the normal appearance of the upper urinary tract, it is highly unlikely that most, if any, of these patients with bladder cancer have tumor in the upper tract despite tumor cells in urine obtained by retrograde catheterization. Thus, upper tract sampling by a retrograde technique lacks specificity for localizing transitional cell cancer to the upper tract when performed in a patient with bladder cancer.

Aged↗

Comparison of digital rectal examination and biopsy results with the radical prostatectomy specimen.

PURPOSE: Digital rectal examination is integral to staging prostate cancer. Ultrasound guided biopsy establishes the diagnosis, and it may provide useful information regarding disease grade and extent. Treatment decisions are largely based on information gained from digital rectal examination and biopsy but this information is only useful if it correlates with the radical prostatectomy specimen and prognosis. We correlated digital rectal examination and transrectal ultrasound guided biopsy results with a detailed analysis of the radical prostatectomy specimen. MATERIALS AND METHODS: The accuracy of an abnormal digital rectal examination for predicting the location and extent of cancer was assessed in 89 patients thought to have clinical stage T2 disease. We evaluated 155 patients with clinical stages T1c and T2 disease to correlate the location of positive biopsies with the tumor site in the prostate. Radical prostatectomy specimens were completely sectioned at 2 mm. intervals, and tumor extent and location were recorded. RESULTS: In 85 patients a unilateral lesion was suspicious on digital rectal examination, that is stage cT2. The final pathological review revealed cancer on the suspicious side in 82 cases (96%) with tumor confined to the same lobe in only 23 (27%), bilateral disease in 59 (69%) and tumor confined to the contralateral lobe in 3 (4%). In 4 patients with a palpable bilateral abnormality a bilateral lesion was confirmed on final pathological evaluation. Digital rectal examination demonstrated a 36 and 31% incidence of extracapsular tumor extension and positive surgical margins, respectively, on the clinically benign side. In 100 patients only unilateral biopsy was positive. The final pathological evaluation revealed cancer in the biopsy positive side in 95 cases (95%) with tumor confined to the ipsilateral lobe in only 26 (26%), bilateral disease in 69 (69%) and tumor confined to the contralateral lobe in 5 (5%). In 46 of the 55 patients (84%) with bilateral positive biopsies tumor involved both sides but the pathologist did not identify cancer in both lobes in 9 (16%). While 100 patients had a unilateral negative biopsy, analysis of the prostatectomy specimen revealed carcinoma in the benign lobe in 74 (74%). Moreover, extracapsular tumor extension and a positive surgical margin were observed on the biopsy negative side in 31% of the patients. The degree to which digital rectal examination and biopsy results confirmed the final pathological evaluation was assessed using the kappa statistic, which revealed only slight agreement with each factor. The correlation of digital rectal examination and biopsy results with the location of extracapsular extension and positive margins was evaluated by the Spearman coefficient of correlation, which indicated poor agreement. When patients with unilateral versus bilateral positive biopsy were compared with respect to prognostic parameters, the difference was statistically significant for initial serum prostate specific antigen, the percentage of surface involved by tumor, biopsy and final Gleason scores, and the incidence of extracapsular extension of tumor. CONCLUSIONS: Digital rectal examination and the interpretation of prostate biopsy are not accurate clinical tools for defining the location and extent of prostatic carcinoma. Bilateral positive biopsy may be useful as an adjunct to the current clinical staging system.

Biopsy, Needle↗