Pain perception during transrectal ultrasound guided prostate needle biopsy: an objective analysis of local anesthesia use.

We assessed the effect of periprostatic nerve blockade during transrectal ultrasound of the prostate prior to obtaining systematic needle biopsies and the discomfort associated with this procedure. A prospective randomized study was performed on 100 men requiring systematic needle biopsy of the prostate. Patients were assigned to two groups: Group 1 received no local anesthesia and Group 2 received a periprostatic injection of 5 ml 1% lidocaine solution (2.5 ml bilaterally) prior to undergoing biopsy of the prostate. The patients were asked to respond to a pre- and post-procedural questionnaire which consisted of four questions designed to evaluate pain perception and pain experienced, respectively, during the entire procedure. Mean pain scores for Group 1 responses vs Group 2 responses were not statistically different for any of the pre-procedural questions. Post-procedural pain scores were significantly lower in Group 2 vs Group 1 (control) for questions 1 and 3: question 1 (2.6+/-1.8 vs 3.8+/-1.8, P<0.05), question 2 (3.0+/-1.9 vs 3.7+/-2.1, P=0.14). Question 3 (2.8+/-2.0 vs 4.3+/-1.9, P<0.05), and question 4 (1.6+/-2.4 vs 2.1+/-2.6, P=0.38). During the study, no patient from Group 2 experienced any adverse reaction from the injection. Our data suggest that periprostatic nerve blockade during transrectal ultrasound of the prostate results in less patient discomfort.

The critical role of patient follow-up after receiving a diagnosis of prostatic intraepithelial neoplasia.

With the increasing incidence of prostatic intraepithelial neoplasia being found at the time of prostate biopsy and the association of prostatic intraepithelial neoplasia to coexisting prostate cancer and/or the future development of prostate cancer, patient compliance in following post-biopsy follow-up instructions for re-biopsy is becoming more significant in the detection of prostate cancer at an earlier and, therefore, potentially curable stage. During a 3-y period, we reviewed the charts of 130 patients who received an initial diagnosis of prostatic intraepithelial neoplasia after undergoing transrectal ultrasound of the prostate with biopsy. It is our policy to inform the patient of their diagnosis of prostatic intraepithelial neoplasia at the time of the initial biopsy and to recommend a repeat biopsy in 6-12 months. Patients are informed of the diagnosis of prostatic intraepithelial neoplasia verbally and in writing. In addition, a letter is sent to their referring physician with the re-biopsy recommendation. Thirty-nine of 130 patients (30%) were seen for re-biopsy within the specified time. An additional 36 patients (27.69%) were re-biopsied between 12 and 18 months after the initial diagnosis of prostatic intraepithelial neoplasia. An additional 11 patients (7%) were re-biopsied more than 18 months after their initial diagnosis. Forty-four patients failed to return for re-biopsy. Overall, patient follow-up within the desired protocol was poor and must be improved upon to prevent any delays in the diagnosis of prostate cancer. Prostate Cancer and Prostatic Diseases (2001) 4, 63-66

Patient noncompliance after vasectomy.

OBJECTIVE: To determine the postoperative instruction compliance rate in men undergoing bilateral vasectomy. DESIGN: Retrospective chart review. SETTING: Private practice urological office. PATIENT(S): The records of all patients undergoing vasectomy were reviewed to determine the rate of compliance with postvasectomy follow-up instructions. It is our policy to have the patient continue to use some form of birth control until he achieves two consecutive negative semen analyses 1 month apart. In addition, we recommend a yearly semen analysis after achieving sterility to screen for the rare patient who recanalizes. Postvasectomy follow-up instructions are given to the patient both verbally and in writing. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): The records of 1,892 consecutive patients undergoing vasectomy were reviewed, and the results of semen analyses were noted to determine the rate of compliance with postvasectomy follow-up instructions. RESULT(S): Six hundred forty-four men (34%) never returned after vasectomy and, therefore, no semen analyses were available for examination. Six hundred nineteen men (33%) returned for a single semen analysis. Six hundred twenty-nine men (33%) returned for a second negative semen analysis. Only 60 men (3%) completed postvasectomy follow-up instructions and returned for a yearly semen analysis. CONCLUSION(S): The rate of compliance with postvasectomy follow-up instructions for determining sterility is poor.

PIP: To determine the rate of patient compliance with post-vasectomy instructions for verifying sterility, the records of all 1892 men undergoing bilateral vasectomy in a private urological practice in Grand Rapids, Michigan, during 1985-95 were reviewed. Vasectomy acceptors at this practice are instructed to use some form of birth control until 2 consecutive negative semen analyses 1 month apart have been recorded. In addition, a yearly semen analysis is recommended to screen for recanalization. These post-vasectomy instructions are delivered verbally on 1 occasion and 3 times in writing. 644 men (34%) never returned after vasectomy. Another 619 men (33%) returned only for a single semen analysis, even though 36 had a positive test result. 629 men (33%) with an initial negative result returned for a second semen analysis; in 65 cases, the second analysis failed to document azoospermia. A total of 157 men with positive first or second semen analyses never were cleared. Only 60 men (3%) returned for the yearly semen analysis. 8 pregnancies (0.4%) were reported in this series, all of which involved men who had not followed the post-vasectomy protocol. These findings underscore the need for thorough patient education on the importance of the post-vasectomy follow-up.

Comparative analysis of prognostic factors in men undergoing radical prostatectomy for adenocarcinoma of the prostate, including DNA ploidy, surgical tumor stage, prostatic specific antigen, Gleason grade, and age.

One hundred consecutive men with adenocarcinoma of the prostate, treated by modified pelvic lymphadenectomy and radical retropubic prostatectomy, were evaluated, comparing DNA ploidy as determined by flow cytometry to surgical tumor stage (pT), preoperative prostatic specific antigen (PSA), Gleason grade, and age at presentation, in an effort to assess the prognostic ability of DNA ploidy. There were 71 (71%) men found to have diploid tumors and 29 (29%) with nondiploid tumors. There was no statistical difference in surgical pathologic stage between these two groups (P = 0.2369). There was no statistical difference when comparing preoperative PSA between these two groups (P = 0.0925). There was no statistical difference when comparing Gleason grade between these two groups (P = 0.5807). Age at presentation was similar in both groups. Based on these findings, it is apparent that longitudinal studies of patient outcome will be necessary to fully assess the prognostic ability of DNA ploidy determined by flow cytometry in men undergoing radical prostatectomy for treatment of adenocarcinoma of the prostate gland.

DNA heterogeneity determined by flow cytometry in prostatic adenocarcinoma--necessitating multiple site analysis.

Although DNA ploidy analysis of prostate cancer is generally associated with grade, stage, clinical outcome, and responsiveness to androgen therapy, one possible reason cited for contrary reports may be tumor heterogeneity. A preliminary report using flow cytometric analysis of punch biopsies demonstrated DNA heterogeneity in five of nine patients. We evaluated 75 patients by cutting whole mounts of formalin fixed prostatectomy tissue every 0.6 cm. All malignant areas and a selected normal area were circumscribed, excised, remounted, and 1-3 50 mu thick sections removed. The nuclei were extracted by a Hedley technique and the DNA stained with propidium iodide. Each whole mount had an average of 1 distinct malignant area (range of 1-6 areas per whole mount block). Nuclei were analyzed on a Becton Dickinson (San Jose, CA) FACScan flow cytometer equipped with RFIT DNA software program. After excluding histograms with CVs > 8.0% and/or "suspicious" diploid histograms having a right "shoulder," 75 or 87 patients still had > or = 2 malignant sites available for analysis (average 4, range 2-9 malignant sites/patient). The 322 histograms had an average CV of 4.4%. Thirty of 75 patients (40%) showed DNA heterogeneity in multiple samples taken from the same prostate. There were 37 prostates with only diploid (D), 1 with only tetraploid (T), 7 with only aneuploid (A), 20 with D plus A, 7 with D plus T, 2 with D plus T plus A, and 1 with a D plus suspected hypodiploid DNA content. Exclusion of the tetraploid and "near diploid aneuploid" cases still resulted in 16% (12/75) of the patients having a diploid versus aneuploid DNA content heterogeneity. Because 40% of the prostates contained a different ploidy depending on which area was sampled, this report suggests multiple sites of malignancy must be analyzed to more accurately assess the ploidy status of prostatic adenocarcinoma.

DNA analysis by flow cytometry of paraffin embedded core biopsies of the prostate.

The majority of literature concerning DNA analysis of prostate cancer involves testing formalin-fixed prostatectomy tissue, fresh or formalin-fixed transurethral resections of the prostate (TURP), or fresh core biopsies. We were interested if flow cytometry could analyze the DNA of formalin-fixed, paraffin-embedded, core biopsies separated into normal versus malignant segments. Of the 50 potentially available samples for analysis representing 11 controls of normal core tissue and 39 core biopsies from the 11 patients, one patient had no normal tissue, one core had no malignancy, and three cores had no tissue visibly remaining in the paraffin blocks for analysis. Therefore, of 45 actual samples available for processing, sometimes representing segments as small as 0.2 cm, separate segments containing malignant glands or normal glands were excised from the blocks, and processed separately by the Hedley technique. Forty-four of the 45 available samples produced interpretable DNA histograms as defined by discernible G0/G1 peaks, a calculable cell cycle analysis, and the qualitative appearance of a "smooth" histogram appearance, reflecting sufficient nuclei were analyzed. This is the first report to our knowledge where flow cytometry has successfully been used to analyze paraffin blocks of core biopsies which were, in addition, separated into malignant versus normal enriched segments.

Comparative analysis of fluctuation of serum tumor markers in advanced cancer of prostate.

Serial serum prostate tumor markers (acid phosphatase, prostate-specific antigen-Yang, prostate-specific antigen-Hybritech, lipid-associated sialic acid in plasma, and tissue polypeptide antigen) were obtained every four hours during a twenty-four-hour interval from men with Stage D adenocarcinoma of the prostate. No therapeutic or diagnostic manipulations occurred during sample procurement, so that the amount of fluctuation in these serum prostate cancer markers could be determined. The average co-efficient of variation for acid phosphatase 28.8, prostate-specific antigen-Yang 8.85, prostate-specific antigen-Hybritech 7.2, lipid-associated sialic acid in plasma (LASA-P) 6.19, and tissue polypeptide antigen (TPA) 14.75 indicate that prostate-specific antigen determined by either method fluctuates minimally, indicating stability and, because it is prostate-cancer specific, is the most useful tumor marker tested.

Effect of glycine on retroperitoneal and intraperitoneal organs in the rat model.

Twenty Sprague Dawley rats were administered various doses of 1.5% amino acetic acid (glycine), lactated Ringer's, and water, both intravenously and retroperitoneally, in an attempt to recreate the post-transurethral resection syndrome in a rat model. The kidneys, liver, and pancreas were harvested 6 hours after exposure and examined pathologically. Water and lactated Ringer's had no histologic effect on these organs. Glycine was found to have a toxic effect on the kidneys and liver and this effect was dose related. Based on these results, it is postulated that glycine toxicity may play a significant role as a causative factor in producing the post-transurethral resection syndrome.

The role of prostate specific antigen as a tumor marker in men with advanced adenocarcinoma of the prostate.

Serial serum prostate specific antigen levels were obtained every 4 hours during a 24-hour interval from 8 men with stage D adenocarcinoma of the prostate. No therapeutic or diagnostic manipulations occurred during sample procurement, so that the amount of fluctuation of serum prostate specific antigen levels that can be expected in these patients could be determined. The coefficient of variation for each man ranged from 1.16 to 10.94 per cent, which was not statistically higher than the expected 4.39 and 11.44 per cent coefficient of variation determined with a control sample. The maximum percentage variations above and below the mean were 19.3 and 17.7 per cent, respectively. The average percentage variation in all patients was within 7.6 per cent greater than and 7.6 per cent less than the mean value of prostate specific antigen. Thus, prostate specific antigen appears to be a reliable tumor marker because there is minimal random fluctuation when serial levels are obtained in men with advanced prostate cancer. Based on these findings certain guidelines are suggested.

Comparing clinical staging plus transrectal ultrasound with surgical-pathologic staging of prostate cancer.

Twenty-five men with histopathologic diagnosis of prostatic adenocarcinoma were staged utilizing traditional staging modalities and transrectal ultrasound of the prostate (TRUSP). A comparison was then done with surgical-pathologic stage. TRUSP accurately predicted the local extent of disease in 84 percent of patients, while digital rectal examination understaged in 64 percent of patients. TRUSP is a valuable adjunct to staging prostate cancer prior to definitive therapy.

Radical cystectomy for carcinoma of the bladder in the elderly patient.

Between 1979 and 1984, 136 patients underwent radical cystectomy and urinary diversion for the treatment of invasive carcinoma of the bladder. Of the patients 38 were 70 years old or more and they were considered elderly. The mortality rates for those less than 70 compared to those more than 70 years old were 1 and 5 per cent, respectively, and the morbidity rates were 39 and 34 per cent, respectively, with wound separation being the most common complication. There was no statistically significant difference with respect to age in the morbidity or mortality rates. The median hospital stay was 14 days but if a complication occurred the hospital stay was significantly longer. For elderly patients in general good health, radical cystectomy and urinary diversion should not be withheld on the basis of age alone.

Erectile dysfunction in men with diabetes mellitus.

During a fourteen-month period, 497 men were evaluated for a primary complaint of erectile dysfunction. The initial evaluation consisted of a history taken in a conventional manner and supplemented by a patient-completed sexual function questionnaire, a physical examination, and serum testosterone, serum prolactin, and nocturnal penile tumescence studies. When appropriate, additional evaluations, including penile vascular studies, two-hour oral glucose tolerance tests, and psychiatric consultation were obtained. Abnormal glucose metabolism was present in 161 men (32%). Five men (1%) had insulin-dependent diabetes mellitus (IDDM), 80 men (16%) had noninsulin-dependent diabetes mellitus (NIDDM), 55 men (11.1%) had newly diagnosed noninsulin-dependent diabetes mellitus, and 21 men (4.2%) had impaired glucose tolerance tests. One hundred forty-seven of these men (91.3%) had organic pattern impotence, and 14 (8.7%) had psychogenic pattern impotence.

Routine endocrine screening in impotence.

Routine hormonal screening (serum testosterone and prolactin) of 300 men presenting with a primary complaint of impotence resulted in detection of endocrine dysfunction in 5 men (1.7%). Four patients had hypogonadism, and 1 patient had a prolactin-secreting pituitary adenoma. The cost of screening these men for endocrine dysfunction was $34,722.00. Despite this cost and the low yield of endocrine disease detection, routine determination of serum testosterone and prolactin provides useful information to the clinician evaluating impotent men and when abnormal, indicates the need for thorough endocrine evaluation.

Cost-effective evaluation of impotence.

Two hundred consecutive men presenting with a chief complaint of impotence have been evaluated with a protocol involving one or two outpatient visits. The initial evaluation for all patients consisted of a history taken in a conventional manner and supplemented by a patient-completed sexual function questionnaire, physical examination, serum testosterone and prolactin, and two-night nocturnal penile tumescence studies. Following the initial evaluation the patients were placed in one of three categories: (1) organic impotence, (2) functional impotence, (3) ambiguous impotence (mixed functional and organic impotence or organic impotence of undetermined etiology). Patients in the latter group underwent additional testing including penile vascular studies, two-hour oral glucose tolerance test, and psychiatric consultation. With this protocol, patients can be efficiently and effectively evaluated as outpatients with costs ranging from +250 to +450.

Intra-arterial chemotherapy as an adjuvant to surgery in transitional cell carcinoma of the bladder.

Regional chemotherapy with intra-arterial cis-platinum and doxorubicin as an adjuvant to total cystectomy and urinary diversion has been evaluated in a phase I to II study. In the first 17 patients chemotherapy consisted of 40 to 75 mg. per m. cis-platinum intra-arterially during 30 minutes, 30 to 40 mg. per m. doxorubicin intra-arterially during 60 minutes (11 patients) or 12 hours (6 patients) and 400 to 500 mg. per m. cyclophosphamide intravenously. The remaining 8 patients received 70 to 100 mg. per m. cis-platinum intra-arterially during 30 minutes. Intra-arterial chemotherapy was administered through a percutaneous catheter placed in the hypogastric artery before each course. Courses were repeated at 4-week intervals. A total of 25 patients received 58 courses (median 2 per patient). Clinical stages of disease in the patients entering the protocol were T3aNxMo (8), T3bNx-2Mo (12) and T4a-bNxMx-1 (5). Clinical response was assessed in 24 of 25 patients: 6 achieved a complete clinical response, 12 had a partial response and 7 had no response. Of 25 patients 16 underwent total cystectomy and urinary diversion with pathological staging as follows: ToNoMo in 3, T1NoMo in 1, T3aNoMo in 5, T3bNo-2Mo in 6 and T4NoMo in 1. Intra-arterial chemotherapy can produce a complete pathological response in patients with locally advanced bladder cancer and is tolerated well by most patients.

Effectiveness of castration versus intravenous estrogen therapy in producing rapid endocrine control of metastatic cancer of the prostate.

Nine men with histologically confirmed stage D cancer of the prostate were evaluated with serial serum testosterone levels after being treated with bilateral orchiectomy or intravenous estrogen. Bilateral orchiectomy produced castrate serum testosterone levels (less than or equal to 50 ng. per 100 ml.) within 2 to 6 hours (mean 3 hours) after surgery. Intravenous estrogen therapy did not consistently produce castrate serum testosterone levels immediately but did significantly decrease testosterone within 12 hours after infusion. Both forms of therapy are safe, produce a clinically effective response and offer advantages for patients with advanced prostatic cancer.

Renal oncocytoma: a diagnostic and therapeutic dilemma.

From 1968 to 1983, 254 patients underwent an operation for presumed renal cell carcinoma. In this retrospective review the pathological diagnosis was renal oncocytoma in 11 patients (4 per cent). Renal oncocytomas were present bilaterally in 2 patients, including 1 with a coexisting renal cell carcinoma. In 2 other patients the oncocytomas were multicentric. The angiographic, computerized tomographic and sonographic findings in these patients typified renal cell carcinoma. Surgical treatment comprised radical or partial nephrectomy for unilateral and bilateral lesions, respectively. Because of the benign nature, multicentricity, possible bilaterality and absence of pathognomonic radiographic features, renal oncocytomas should be considered in the differential diagnosis of solid renal masses.

The role of serum prostatic acid phosphatase as a tumor marker in men with advanced adenocarcinoma of the prostate.

Serial serum prostatic acid phosphatase levels were obtained every 4 hours during a 48-hour interval from 10 men with stage D adenocarcinoma of the prostate. No therapeutic or diagnostic manipulations occurred during sample procurement, so that the amount of fluctuation of serum prostatic acid phosphatase levels that can be expected in these patients could be determined. The coefficient of variation for each man ranged from 16.67 to 43.68 per cent, which was significantly higher than the expected 8 per cent coefficient of variation determined with a control sample. The maximum percentage variations above and below the mean were 79 and 50 per cent, respectively. The average percentage variation in all patients was within 50 per cent greater than and 50 per cent less than the mean value of prostatic acid phosphatase. Thus, the usefulness of serum acid phosphatase by radioimmunoassay as a clinical tumor marker is limited by the number of serial assays needed to establish a mean. Based on these findings, certain guidelines are suggested.