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The precursor form of the human kallikrein 2, a kallikrein homologous to prostate-specific antigen, is present in human sera and is increased in prostate cancer and benign prostatic hyperplasia.

Prostate-specific antigen (PSA, hK3) is a diagnostic marker for prostatic cancer but lacks the specificity to sufficiently distinguish between prostatic cancer and benign prostatic hyperplasia (BPH). Human glandular kallikrein 2 (hK2) has been proposed as a potential diagnostic marker for prostate cancer that could complement the current PSA test. Recently we demonstrated that proPSA is present in prostate cancer sera. This study examines the expression of prohK2 in prostate cells and its presence in human sera. Western blot analysis was used to assess prohK2 expression in the human carcinoma cell line, LNCaP. A highly specific and sensitive dual monoclonal immunoassay for prohK2 was developed and used to assess the presence of prohK2 in human sera. prohK2 was detected in the spent media of LNCaP cells. Furthermore, prohK2 was present at immunodetectable concentrations in human sera, and its concentration was increased in prostatic cancer and BPH. These results indicate for the first time that prohK2 is secreted by human prostate cells and is a major component of uncomplexed (free) hK2 in human sera. In addition, prohK2 in human sera is associated with prostate disease and thus may be a useful marker for prostatic cancer and BPH.

Antibodies, Monoclonal↗

Comparison of the effects of new specific azasteroid inhibitors of steroid 5 alpha-reductase on canine hyperplastic prostate: suppression of prostatic DHT correlated with prostate regression.

Four new azasteroid inhibitors of steroid 5 alpha-reductase were compared to the benchmark compound finasteride, each at a dose level of 1 mg/kg/day, as well to placebo and to castration, in seven groups of mature male beagle dogs with enlarged prostates. Prostate volumes were measured repetitively by a volume MRI method over 15 weeks of treatment. The study probed the obverse of the familiar relation between DHT and prostate growth, and provides the first documentation of a tight negative correlation between prostate regression and the prostatic concentration of DHT across a range of treatment regimens (r = -0.982). In this first direct comparison study of structure vs. in vivo activity for several azasteroids in the dog model of BPH, relative efficacy for induction of shrinkage of the dog prostate did not correlate at all with the inhibitor's relative activity against the dog 5 alpha-reductase in vitro. On the basis of the relative IC50 values it would not have been predicted that, at the dose tested, the analogue MK-434 (17 beta-benzoyl-4-aza-5 alpha-androst-1-en-3-one) was distinguished from the other inhibitors with respect to the induction of faster and more complete regression (69%) as well as greater reduction in prostatic DHT (95%), both of which approached the castrated dog levels of 75% prostatic shrinkage and > 98% reduction in DHT. Treatment with any one of the five azasteroids induced two- to five-fold increases in prostatic testosterone. However, total androgen was conserved at the placebo control level. Despite the differences noted, each azasteroid tested induced a highly significant decrease in prostatic volume that correlated tightly with a decreased prostatic DHT level in canine spontaneous BPH.

5-alpha Reductase Inhibitors↗

Relative value of prostate-specific antigen and prostatic acid phosphatase in diagnosis and management of adenocarcinoma of prostate. Ohio State University experience.

Serum concentrations of prostate-specific antigen (PSA), prostate-specific acid phosphatase (PAP), and transrectal prostatic ultrasound were utilized in the evaluation of 193 men with various urologic disorders. Of the 193 patients, 48 had prostate cancer, and the other 145 included 5 with genitourinary neoplasms, 69 with benign prostatic hypertrophy, and 71 with other non-neoplastic genitourinary disease. PSA levels were elevated in 35 patients with prostate cancer and in 25 of the 145 without prostate cancer. PAP levels were elevated in 15 with prostate cancer and in 2 of the 145 without prostate cancer. The data indicate that PSA is a more sensitive but less specific tumor marker than PAP in the detection of prostate cancer. PSA appears to be more sensitive than PAP in monitoring the response to treatment. The use of PSA and PAP jointly to detect and to monitor prostate cancer did not appear to enhance the clinical utility over that of PSA alone.

Acid Phosphatase↗

Effect of prostatic biopsy on free-to-total prostate-specific antigen ratio in patients with prostate cancer.

BACKGROUND: We determined the effect of prostatic biopsy on the changes in total and free prostate-specific antigen (PSA) and free-to-total PSA ratio (F/T ratio) and examined if there are differences in these parameters between patients with benign and malignant histologic findings. METHODS: The concentration of total and free PSA and the F/T ratio were determined in 35 men before and 1 h after prostatic biopsy. The level of PSA was measured with a chemiluminescent enzyme assay. Of 35 patients, nine were diagnosed as having prostate cancer. RESULTS: In patients whose biopsy revealed cancer, the F/T ratio was lower than those without cancer, although there were no differences in total and free PSA value before prostatic biopsy. One hour after prostatic biopsy, there was an increase in the level of total and free PSA and the F/T ratio in all men. The increase in the F/T ratio was greater in patients whose biopsies revealed no prostate cancer. In patients with stage B cancer, these parameters increased more than those with stage C/D cancer. CONCLUSION: Prostatic biopsy causes a dramatic increase in total and free PSA. The F/T ratio also increased after biopsy. The PSA response to prostatic biopsy might be different in patients with and without prostatic malignancy. The response might also be different according to stage of prostate cancer.

Aged↗

A randomized trial comparing holmium laser enucleation of the prostate with transurethral resection of the prostate for the treatment of bladder outlet obstruction secondary to benign prostatic hyperplasia in large glands (40 to 200 grams).

PURPOSE: Holmium laser enucleation of the prostate (HoLEP) is a surgical treatment for bladder outlet obstruction secondary to benign prostatic hyperplasia. HoLEP is a transurethral procedure that uses the holmium laser fiber (wavelength 2,140 nm) to dissect whole prostatic lobes off of the surgical capsule in retrograde fashion, while maintaining excellent hemostasis. The lobes are removed from the bladder by a purpose built transurethral morcellator, which means that large volume prostates can be enucleated endoscopically. We compared this procedure with transurethral prostate resection (TURP) in a randomized trial by evaluating outcomes in patients with a prostate volume of 40 to 200 ml on transrectal ultrasound. MATERIALS AND METHODS: A total of 61 patients with urodynamically proved bladder outlet obstruction secondary to benign prostatic hyperplasia were randomized to TURP or HoLEP. Perioperative parameters recorded included resectoscope, laser, electrocautery, morcellation and catheter time, hospital stay, bladder irrigation, volume blood transfusion the rate and resected tissue weight. Patients were followed 1, 3, 6 and 12 months postoperatively with peak urinary flow rate measurement and quality of life and American Urological Association symptom scores. Patients also underwent urodynamic assessment at 6 months with measurement of peak detrusor pressure at maximal flow, post-void residual volume and prostate volume by transrectal ultrasound. Continence, potency and all adverse events were recorded at each visit. RESULTS: HoLEP was superior to TURP in terms of mean catheter time (17.7 +/- 0.7 vs 44.9 +/- 10 hours) and hospital stay (27.6 +/- 2.7 vs 49.9 +/- 5.6 hours) but it required more time to perform (62.1 +/- 5.9 vs 33.1 +/- 3.7 minutes). More prostate tissue was removed in the HoLEP group (40.4 +/- 5.7 vs 24.7 +/- 3.4 gm). HoLEP was also superior to TURP in terms of relieving urodynamic obstruction at 6 months of followup (postoperative detrusor pressure at maximum flow 20.8 +/- 2.8 vs 40.7 +/- 2.7 cm H2O). HoLEP and TURP led to significant improvements in peak flow rates, symptom scores and quality of life scores compared with baseline and there was no significant difference between the 2 procedures with respect to these parameters at 12 months. Fewer adverse events were recorded in the HoLEP group. CONCLUSIONS: HoLEP is superior to TURP for relieving bladder outlet obstruction in men with benign prostatic hyperplasia. It allows more rapid catheter removal and hospital discharge. It requires more time to perform than TURP but more prostate tissue is removed, resulting in similar efficiency in tissue retrieval. HoLEP is equivalent to TURP in relieving men of lower urinary tract symptoms and in improving peak urinary flow rates at 12 months of followup.

Aged↗

[Influence of androgen deprivation therapy on prostate volume in patients with prostate cancer undergoing prostate brachytherapy with permanent seed implantation].

OBJECTIVE: Enlarged prostate often causes pubic arch interference during needle insertion on transperineal interstitial permanent prostate brachytherapy. Pre-treatment hormonal therapy is necessary for downsizing the prostate gland in such cases. The degree of prostate downsizing with anti-androgen treatment before iodine 125 permanent seed implant brachytherapy and its relation to clinical as well as pathological parameters were assessed. METHODS: From September 2003 to March 2005, 110 patients underwent permanent seed implantation and 86 patients of all received antiandrogen depriviation prior to the treatment at our institute. Prostate volume was measured using transrectal ultrasound at the time of cancer diagnosis and before the seed implant. Correlations between prostate downsizing and clinical as well as pathological parameters were evaluated. RESULTS: Mean percent volume of the prostate after the size reduction with average of 6.0 months antiandrogen monotherapy, 7.7 months LHRH agoniost and 8.2 months maximum androgen blockage (MAB) was 83%, 63%, and 60%, respectively. Mann-Whitney U test revealed that the degree of prostate downsizing is significantly correlated with the prostate volume in patients with prostate cancer utilizing LHRH agonists. CONCLUSIONS: Antiandrogen monotherapy can be an alternative for prostate downsizing before interstitial brachytherapy. Utilizing LHRH agonists or MAB is recommended for cases with larger gland volume.

Aged↗

Bacterial dna sequences in prostate tissue from patients with prostate cancer and chronic prostatitis.

PURPOSE: Although bacterial genetic material has been detected in prostate tissue from patients with various disorders, the prevalence of these organisms is unknown. We tested the hypothesis that bacterial detection rates differ between patients with prostate cancer and those with the chronic prostatitis/pelvic pain syndrome. MATERIALS AND METHODS: Sterile prostate biopsies were obtained during radical retropubic prostatectomy from 107 patients with prostate cancer and using a perineal approach from 170 with the chronic prostatitis/pelvic pain syndrome. Numerous controls were also evaluated. Bacterial ribosomal encoding DNA (165 rDNA) sequences were detected using a polymerase chain reaction assay. Selected positives were cloned, sequenced and compared with DNA databases. RESULTS: Bacterial DNA sequences were detected in 21 (19. 6%) of 107 patients with prostate cancer compared to 79 (46.4%) of 170 with chronic prostatitis (p <0.0001). These bacteria included urogenital pathogens, other described microorganisms and bacteria not reported previously. CONCLUSIONS: Bacterial DNA sequences may be identified in prostate tissue from many patients. Bacterial detection rates in prostate tissue appear to differ among populations, with higher rates among patients with the chronic prostatitis/pelvic pain syndrome than among those with prostate cancer. Future studies of the role of various bacteria in the prostate may provide insight into the pathophysiology of prostate disease.

Adolescent↗

Sensitive nested reverse transcription polymerase chain reaction detection of circulating prostatic tumor cells: comparison of prostate-specific membrane antigen and prostate-specific antigen-based assays.

A highly sensitive nested reverse transcriptase-PCR assay, with primers derived from the prostate-specific antigen (PSA) and prostate-specific membrane antigen (PSM) cDNA sequences, has been used to detect occult hematogenous micrometastatic prostate cells. In 77 patients with prostate cancer, PSM and PSA primers detected circulating prostate cells in 48 (62.3%) and 7 (9.1%) patients, respectively. In treated stage D disease patients, PSM primers detected cells in 16 of 24 patients (66.7%), while PSA primers detected cells in 6 of 24 (25%). In post-radical prostectomy patients with negative serum PSA values, PSM primers detected metastases in 21 of 31 patients (67.7%), whereas PSA primers detected cells in only 1 of 33 (3.0%), indicating that micrometastatic spread may be a relatively early event in prostate cancer. The analysis of 40 individuals without known prostate cancer provides evidence that this assay is highly specific and suggests that PSM expression may predict the development of cancer in patients without clinically apparent prostate cancer. Using PSM primers, we detected micrometastases in 4 of 40 controls, 2 of whom had known benign prostatic hyperplasia and were later found to have previously undetected prostate cancer. The clinical significance of detection of hematogenous micrometastic prostate cells using PSM primers and potential applications of this molecular assay, as well as the assay for PSA, merit further study.

Antigens, Neoplasm↗

Relationship among age, prostate-specific antigen, and prostate volume in men with lower urinary tract symptoms (LUTS) and in different groups of men with and without benign and malignant prostate diseases.

BACKGROUND: In order to enhance prostate-specific antigen (PSA) as a predictor of prostate cancer, it is necessary to understand the characteristics of this tumor marker in a population of men without evidence of prostate cancer but who are at risk for developing the condition. METHODS: In an age-stratified population of 328 men with lower urinary tract symptoms (LUTS), we analyzed the distribution of PSA levels as a function of age and prostate volume, and we analyzed the percentage of age-related variance in PSA that can be explained by the age-related variance in prostate volume. RESULTS: Classifying the 328 cases with LUTS according to four age groups, a correlation was found between PSA and prostate volume, becoming stronger from the younger (correlation coefficient, -0.1265) to the older group (correlation coefficient, 0.6044). Serum PSA variance per milliliter of prostate volume also increased from the younger (not significant, P > 0.1) to the older age decades (7.3% in men age 70 years or over). Moreover, the results of the regression analysis suggest that 10% of the variance in PSA with age can be accounted for by prostate volume in men under age 50 years, reaching 37% in men age 70 years or more. CONCLUSIONS: These data confirm that the serum PSA concentration increases with advancing age in the absence of clinically evident prostatic malignancy. In younger patients with LUTS, serum PSA variance with age seems to be less dependent upon the age-related variance in prostate volume.

Adult↗

Evaluation of prostate-specific antigen and prostatic acid phosphatase as prostate cancer markers.

Prostate-specific antigen (PSA) and prostatic acid phosphatase (PAP) have been evaluated in patients with prostate cancer, benign prostatic hypertrophy (BPH), and prostatitis. PSA has proved to be diagnostically more sensitive than PAP for the detection of prostate cancer: 95.0 per cent vs 60.0 per cent for 40 newly diagnosed cancer cases, and 97.1 per cent vs 65.7 per cent for 35 relapsed cases. This also holds true for those patients with early-stage disease: 71.4 per cent vs 0 per cent for 7 Stage A1 cases. The specificities of PSA and PAP are comparable, 96.8 per cent vs 98.9 per cent, respectively. PSA is also more sensitive for monitoring therapy, since it usually rises before PAP and always precedes clinical signs of relapse. Although PSA may be elevated more frequently than PAP in some patients with BPH and prostatitis, it is postulated that these patients with elevated serum PSA and normal serum PAP may fall into a high-risk sub-population which may have early prostate cancer or precancerous conditions not easily detectable by current clinical and diagnostic techniques. Our data suggest PSA is a sensitive useful tumor marker for the diagnosis and management of prostate cancer. In addition, PAP, in combination with PSA, may serve as a useful adjunct for differential diagnosis and confirmation of advanced stage prostate cancer.

Acid Phosphatase↗

Relationship between Prostatic Specific Antigen (PSA) and volume of the prostate in the Benign Prostatic Hyperplasia in the elderly.

Increase of the Prostatic Specific Antigen (PSA) is a non-invasive, sensitive and specific markers for prostatic diseases, including prostatic cancer. However, age-related Benign Prostatic Hyperplasia (BPH), as well as prostatitis, may at the same time alter PSA values. The aim of this study was to evaluate the relationship between ageing and PSA, and whether age-specific upper normal limits of PSA should be considered for elderly patients. We evaluated 569 consecutive subjects aged 60 years or more (mean age 74.2 years) who were free from malignant prostatic disease, without clinical evidence of prostatic phlogosis and who were not receiving PSA levels affecting drugs. All patients underwent Digital Rectal Examination (DRE) and Trans-Rectal Ultrasonography (TRU), with determination of the three prostatic diameters, the Maximum Adenoma Diameter (MAD) and calculation of the prostatic volume (PV) by the ellipsoid formula. PSA was determined in all patients before DRE and TRU, and the PSA free ratio was determined in those with total PSA values >4 ng/ml. The PSA density was calculated according to the formula PSA/PV. One hundred and seventy-nine subjects (31.6%) were found to have PSA values >4 ng/ml: among them, 26 (14.5%) had values exceeding 10 ng/ml. Age was slightly correlated with PV (P<0.05), but not with PSA values. On the contrary, PSA values were strongly related with PV and MAD (P<0.01 both). Mean PSA-free ratio was 16.3+/-6.0% and most of patients had values in the so-called 'grey zone' of discrimination between benignity and malignity. Elevated PSA levels are common in older subjects without evidence of prostatic malignancy; PSA values are poorly affected by age itself and strongly correlated with increasing PV. These results suggest the possibility to consider as indicative of benignity PSA values between 4 and 10 ng/ml, when these values are associated with relevant increase of PV and with PSA-free ratio greater than 10%.

Age Factors↗

Incidental acute prostatic inflammation is associated with a lower percentage of free prostate-specific antigen than other benign conditions of the prostate: a prospective screening study.

OBJECTIVE: To evaluate the performance of percentage free/total prostate-specific antigen (f/tPSA) as a screening tool for prostate cancer, and to assess the impact of prostatic inflammation on f/tPSA. PATIENTS AND METHODS: Men aged 50-65 years were invited for prostate cancer screening. Biopsies were taken from men with a tPSA of > or = 4 ng/mL, together with those with a tPSA of 1.1-3.99 ng/mL and a f/tPSA of < or = 20%. Histological evidence of prostate cancer, acute inflammation, chronic inflammation, and benign prostatic tissue were noted in biopsy cores, together with the associated f/tPSA values. RESULTS: The cancer detection rate was 4.3% (33/773). Evidence of inflammation was found in about half (87/175) of those biopsied. Men with acute inflammation (27/175, 15%) had significantly lower serum f/tPSA values (mean 13.4%) than those with chronic inflammation (mean 16.6%, P = 0.002) and benign prostatic tissue (mean 15.7%, P = 0.034), but were similar to men with prostate cancer (mean 15.3%, P = 0.315). CONCLUSIONS: In this prospectively screened cohort of men, there was a high incidence of asymptomatic inflammation on prostatic histology; f/tPSA values were significantly lower in men with acute inflammation. This might explain the variability of f/tPSA in improving specificity when used as a screening tool for prostate cancer, and might also reduce its effectiveness in differentiating tumours with more aggressive potential.

Acute Disease↗

Changes in the endocrine environment of the human prostate transition zone with aging: simultaneous quantitative analysis of prostatic sex steroids and comparison with human prostatic histological composition.

BACKGROUND: It is well-known that the incidence of benign prostatic hyperplasia (BPH) increases with aging. The age-dependent changes in the ratio of serum sex steroid concentrations may play a role in BPH development. To clarify the relationship between the prostatic tissue concentrations of these steroids and age, we established a precise method of simultaneous quantitative analysis for prostatic sex steroids and used this method to investigate the tissue concentrations of three major sex steroids (testosterone, dihydrotestosterone, and estradiol) in the human prostate. METHODS: The methodology for the simultaneous quantitative analysis of prostatic sex steroids was established using castrated rat prostatic tissue, coupled with internal standards, for androgen-deprived medium, and the validation of the method was examined. Human prostatic tissues were collected during surgery and immediately frozen at -70 degrees C. Using our method, the steroidal fractions were extracted, purified, and quantified. The proportions of stroma, epithelium, and glandular lumen were measured on each histological specimen, using an image analyzer. RESULTS: The validation tests showed that our method of quantitative analysis was precise and sensitive enough for the quantification of testosterone, dihydrotestosterone, and estradiol in the prostate. In humans, the prostatic dihydrotestosterone concentration decreased with age, but the concentrations of testosterone and estradiol showed no relation with age. Therefore, the ratio of estradiol to dihydrotestosterone concentration (E2/DHT) in prostate increased with age. The E2/DHT ratio showed a significant positive correlation with the proportion of stroma. CONCLUSIONS: The age-dependent decrease in prostatic dihydrotestosterone and constant estradiol concentration lead to a relatively estrogen-dominant environment compared to that at younger ages. We assume that this relatively estrogen-dominant status induces stromal proliferation by some mechanism and leads to the development of BPH.

Aged↗

[Significance of prostatic acid phosphatase, gamma-seminoprotein and prostatic specific antigen in the urine. First report: the measurement of PAP, gamma-Sm and PA in the urine of patients with prostatic diseases].

To study the significance of prostatic acid phosphatase (PAP), gamma-seminoprotein (gamma-Sm) and prostatic specific antigen (PA) in urine, we have determined the urinary levels of these proteins in women and infants, in patients without prostatic disease, in patients with benign prostatic hypertrophy, and in patients with prostatic adenocarcinoma. Women and infants were found to excrete little PAP (27.9 +/- 4.8 ng/mg) and undetectable levels of gamma-Sm except one case, and undetectable levels of PA in the urine. The excretion of PAP in patients with prostatic carcinoma who were either castrated, or treated with endocrine therapy was lower than the levels in women and infants, or the levels in patients without prostatic diseases, or the levels in patients with BPH. Urinary excretion levels of gamma-Sm and PA were undetectable in the patients with well-controlled prostatic carcinoma. The present study suggests that the determination of PAP, gamma-Sm and PA in the urine of patients with prostatic carcinoma may become a useful tool for monitoring of the primary locus of the carcinoma, but additional assays of urinary PAP, gamma-Sm and PA should be measured at regular intervals to be concluded.

Acid Phosphatase↗

Relationship of prostate-specific antigen and prostate volume in patients with biopsy proven benign prostatic hyperplasia.

BACKGROUND: Emerging data suggest a direct correlation between prostate-specific antigen (PSA) and prostate volume in patients with lower urinary tract symptoms (LUTS) and clinical evidence of benign prostatic hyperplasia (BPH). We attempt to confirm that a similar correlation exists between PSA and prostate volume in patients with biopsy-proven BPH. METHODS: Over a 5 year period, 2,270 patients were confirmed to have BPH as the only histological diagnosis after evaluation with serum PSA, trans-rectal ultrasound (TRUS) biopsy, and prostate volume measurement. PSA and prostate volume were statistically analyzed by age-stratified cohorts, including multiple regression analysis and assessment of correlation using the Pearson correlation coefficient (r). RESULTS: Mean PSA and prostate volume increased with each advancing cohort of age, and the correlation of PSA and prostate volume was determined to be statistically significant (P < 0.001) in each cohort with a correlation coefficient ranging from 0.33 to 0.41. CONCLUSIONS: We confirm that the relationship between PSA and prostate volume in a large series of patients with biopsy-proven BPH provides a comparable correlation to data for patients with LUTS and clinical BPH. As such, PSA represents a valuable approximation of prostate volume, and may prove to be clinically useful in the management of patients with BPH.

Adult↗

Prostate specific antigen cannot distinguish stage T1a (A1) prostate cancer from benign prostatic hyperplasia.

To determine if serum prostate specific antigen (PSA) has decreased the prevalence of stages T1a (A1) and T1b (A2) prostate cancer, and to compare the PSA values for patients with stages T1a and T1b prostate cancer and men with symptomatic benign prostatic hyperplasia, 966 patients undergoing transurethral resection of the prostate were evaluated retrospectively. Included in the study population were 499 consecutive patients who underwent transurethral resection of the prostate for obstructive urinary symptoms in 1986 (no PSA group), and 467 consecutive patients who underwent resection in 1989 and 1990 who were evaluated with serum PSA preoperatively (PSA group). The mean age for the no PSA group was 71 years compared to 70 years for the PSA group (p = 0.36). The overall prevalence of stages T1a and T1b prostate cancer in the no PSA group was 8.6% compared to 10.3% in the PSA group (p = 0.37). The prevalence of stages T1a and T1b prostate cancer in the no PSA group was 3.6% and 5.0%, respectively, compared to 7.3% and 3.0%, respectively, for the PSA group (p = 0.01). In the PSA group the median PSA value for patients with stages T1a and T1b prostate cancer was 3.8 ng/ml compared to 3.4 ng/ml for the patients without cancer (p = 0.59). The median PSA level for the stage T1a cancer patients was 2.4 ng/ml, which was not statistically different from that in patients without cancer (p = 0.31), and the median PSA level for the stage T1b cancer patients was 5.9 ng/ml, which was statistically different than that in patients without cancer (p = 0.01). These findings suggest that the routine use of serum PSA does not decrease the prevalence of stage T1a prostate cancer and that PSA may decrease the prevalence of stage T1b tumors but a larger study would be necessary to document this finding.

Adult↗

Lack of value of radioimmunoassay for prostatic acid phosphatase as a screening test for prostatic cancer in patients with obstructive prostatic hyperplasia.

We examined the incidence of prostatic cancer in patients with an elevated radioimmunoassay for prostatic acid phosphatase and clinical benign prostatic hyperplasia on digital rectal examination. Of 295 patients screened with prostatic acid phosphatase tests 17 fulfilled the criteria of having an elevated prostatic acid phosphatase, clinically benign prostate and histological examination of the prostatectomy specimen. None of the 17 patients had histological evidence of prostatic cancer. The results confirm the predictions of mathematical models that prostatic acid phosphatase is of no practical value as a screening test for prostatic cancer in patients with clinical benign prostatic hyperplasia.

Acid Phosphatase↗

Comparison of three assays for total serum prostate-specific antigen and percentage of free prostate-specific antigen in predicting prostate histology.

OBJECTIVES: To determine the statistical performance of three different assays for prostate specific antigen (PSA) and the percentage of free PSA with respect to the differentiation of histologic benign prostatic hyperplasia (BPH) and prostate cancer in men who underwent surgical removal of prostate tissue. METHODS: Serum of 86 men scheduled for prostate surgery (transurethral resection of the prostate [TURP], simple open prostatectomy, radical prostatectomy, cystoprostatectomy) was frozen and subjected to measurement in batches using three different assays for total PSA (Hybritech Tandem-E, Abbott IMx, Tosoh AIA-600) and free PSA by the Hybritech method after a single freeze-thaw cycle. The histologic diagnosis of the removed tissue (35 BPH and 51 cancer) was used as a "gold standard" for classification of disease status. Sensitivity, specificity, positive and negative predictive values, and diagnostic efficiency were calculated for the three total PSA assays and the free/total PSA ratios for the entire cohort and subsets. Receiver-operating characteristic (ROC) curve analysis was used to compare the performance of the assays and ratios. RESULTS: Mean and median total PSA values differed slightly between the three assays for all patients, and for those with BPH and cancer, but this difference was not significant. Because of a considerable overlap, the differences between the mean PSA values for men with BPH and prostate cancer were not significant. At a cutpoint of 4.0 ng/mL, sensitivity with respect to the differentiation between BPH and prostate cancer was 68.6% for all three total PSA assays; the respective AUCs (0.613-0.625) were not significantly different. While the performance of the free/total PSA ratios was superior, the differences were only significant when subsets of patients were considered with a total PSA between 4 and 10 ng/mL or 4 and 15 ng/mL (AUCs 0.789-0.816). Likewise, sensitivity, specificity, and diagnostic efficiency was better in these subsets of patients. CONCLUSIONS: In this study in which a "gold standard" based on histologic analysis of the entire (or large part of) the prostate gland was used to classify disease status, the three assays for total serum PSA (Hybritech Tandem-E, Abbott IMx, and Tosoh AIA-600) performed very similarly with identical sensitivities (at a cutpoint of 4.0 ng/mL) and comparable AUCs with respect to the differentiation of men with histologic BPH and prostate cancer. The ratios of free/total PSA calculated as free PSA by the Hybritech manual immunoradiometric assay (IRMA) method over all three total PSA assays, performed marginally better in the entire patient population. However, in the subsets of patients with a PSA of 4-10 ng/mL and 4-15 ng/mL, all three ratios performed significantly better than the three total PSA assays. The proper choice of a cutpoint for the ratio (15%, 17%, 19%, or 21%) depends on the desirability of maximizing either sensitivity or specificity while optimizing diagnostic efficiency.

Adult↗