Serum Prostate-specific Antigen In Men Research Articles

Correlations between prostate cancer with prostate specific antigen levels in patients

Background: The influence of geographical, ethnic differences, different races possess their respective reference ranges of serum Prostate-Specific Antigen (PSA). The distribution of serum PSA in men without prostate cancer. Aims: We have investigated the importance of early detection in patients with Lower Urinary Tract Symptoms (LUTS), in whom prostate cancer has been suspected despite a negative trans rectal ultrasound (TRUS) biopsy, by the transition zone of prostate cancer by transurethral resection of the prostate (TURP). Methods: A total of 63 patients undergoing TURP were evaluated of the period from July 2019 to March 2020. TRUS biopsy patients before TURP (group with cancer) and not (without cancer) were compared to the prostate detection rates. All charts, including prostate-specified antigen (PSA), digital rectal exam (DRE) results, TURP (including volume of resection and a pathology report), and TRUS biopsy results, were evaluated retrospectively. Ethnicity has not been recorded since Al-Najaf is multi-ethnic. Description statistics, statistic tables, the arithmetic medium, standard error, default and two extremes used to analyze the results. Results: PSA values in different age groups were non-significantly different in cancer detection rate between with and without biopsy groups, the PSA mean was 4.7± 1.6 ng / ml and 3.4± 0.8 ng / ml, and also IPSS was 10.8± 1.4 and 9.1± 2.65 and p>0.05 and while APEL (%) mean was 5.65± 2.5 ng / ml and 10.5± 1.35 ng / ml that showed significant difference between with and without biopsy groups and p<0.05. The detection rate for prostate cancer and PSA (p=0.01) have been positively correlated. Conclusion: The results of serum PSA must be standardized by country and ethnic group. Ultimately, the diagnosis of prostatic carcinoma in a particular region will increase accuracy.

MP73-12 UNSUSPECTED METASTASES FOUND DURING SCREENING FOR A TRIAL OF PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER

You have accessJournal of UrologyProstate Cancer: Advanced I1 Apr 2015MP73-12 UNSUSPECTED METASTASES FOUND DURING SCREENING FOR A TRIAL OF PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER E. David Crawford, Jannell R. DePalantino, Philip W. Kantoff, Neal Shore, Willie Underwood, Vijay Reddy, Jim Wang, Suneel Mundle, Zane Yang, Tracy McGowan, and Charles J. Ryan E. David CrawfordE. David Crawford More articles by this author , Jannell R. DePalantinoJannell R. DePalantino More articles by this author , Philip W. KantoffPhilip W. Kantoff More articles by this author , Neal ShoreNeal Shore More articles by this author , Willie UnderwoodWillie Underwood More articles by this author , Vijay ReddyVijay Reddy More articles by this author , Jim WangJim Wang More articles by this author , Suneel MundleSuneel Mundle More articles by this author , Zane YangZane Yang More articles by this author , Tracy McGowanTracy McGowan More articles by this author , and Charles J. RyanCharles J. Ryan More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2688AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Factors associated with rates of progression from non-metastatic to metastatic castration resistant prostate cancer (CRPC) have been described.1,2 We used this information to identify patients at high risk for progression from non-metastatic to metastatic disease (MD) for entry into the IMpact of Abiraterone Acetate in Prostate Specific AntiGEN (IMAAGEN) trial. To report the high rate of unsuspected metastases in asymptomatic patients with CRPC, leading to screen failure. METHODS From April 2011-July 2013, patients were screened for entry into the IMAAGEN trial. Key entry criteria included having CRPC as defined by a rising PSA and a serum T < 50 ng/dL and a PSA ≥ 10 ng/mL or PSA doubling time (PSADT) ≤ 10 months. Primary endpoint of IMAAGEN was proportion of subjects achieving a ≥ 50% reduction in PSA by 6 cycles of treatment. During screening, patients who met entry criteria based on laboratory results underwent imaging studies to screen for local disease progression or MD. RESULTS 298 patients were screened. 167 (56%) patients screen failed. 77 patients had MD, which represents 37% of 208 patients who, by lab results, were eligible for and underwent imaging studies. We will report on the relationship of unsuspected MD to PSA/PSADT entry criteria. CONCLUSIONS A high rate of unsuspected asymptomatic MD was found in this high-risk CRPC patient population (PSA ≥ 10 ng/mL or PSADT ≤ 10months). Our findings build upon other reported data on MD discovered during screening for non-metastatic CRPC trials.3 These findings suggest the need to prospectively define risk factors for development of MD in CRPC to assure timely identification, especially in light of new treatment options. 1Smith MR, Kabbinavar F, Saad F et al. Natural History of Rising Serum Prostate-Specific Antigen in Men with Castrate Nonmetastatic Prostate Cancer. J Clin Oncol 2005;23:2918-2925. 2Smith MR, Cook R, Lee K et al. Disease and Host Characteristics as Predictors of Time to First Bone Metastasis and Death in Men with Progressive Castration-Resistant Nonmetastatic Prostate Cancer. Cancer 2011;117:2077-85. 3Yu EY, Miller K, Nelson J et al. Detection of previously unidentified metastatic disease as a leading cause of screening failure in a phase III trial of zibotentan versus placebo in patients with nonmetastatic, castration resistant prostate cancer. J Urol 2012;188:103-109. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e934 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information E. David Crawford More articles by this author Jannell R. DePalantino More articles by this author Philip W. Kantoff More articles by this author Neal Shore More articles by this author Willie Underwood More articles by this author Vijay Reddy More articles by this author Jim Wang More articles by this author Suneel Mundle More articles by this author Zane Yang More articles by this author Tracy McGowan More articles by this author Charles J. Ryan More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Association between systemic inflammatory markers and serum prostate-specific antigen in men without prostatic disease-The 2001-2008 National Health and Nutrition examination survey

Serum prostate specific antigen (PSA) may be elevated in otherwise healthy men; systemic inflammation has been associated with cancer. The study of systemic inflammatory markers in men without clinical prostate disease, but with elevated PSA may characterize the subgroup of men at higher risk for subsequent prostate cancer. We investigated the associations between systemic inflammatory markers and serum PSA in 3,164 healthy men without prostatic disease, aged >40 years, from the 2001 to 2008 U.S. National Health and Nutrition Examination Survey (NHANES). Serum total PSA levels and concentrations of serum C-reactive protein (CRP) and plasma fibrinogen, neutrophil count, lymphocyte count, and platelet count were recorded. Neutrophil-lymphocyte ratio (NLR) ratio and platelet-lymphocyte (PLR) ratio were calculated. PSA elevation was defined as levels equal or greater than 4 ng/ml. Elevated serum PSA (194 men, 6.1% of the total), was significantly associated with plasma fibrinogen (ORmultiv = 1.88; 95% CI, 1.09-3.25), and NLR (ORmultiv = 1.14; 95% CI, 1.03-1.26), after adjustment for age, smoking, body mass index, education, race, co-morbidities, and use of medications. Markers of systemic inflammation were associated with elevated PSA in men without known prostatic disease. Future studies are needed to examine these markers' relationship with prostate cancer occurrence and progression.

Abstract C32: Associations between systemic inflammatory markers and elevated serum prostate specific antigen in men with no evidence of prostatic disease

Abstract Introduction: Systemic inflammation has been reported to be associated with progression and poorer survival for cancer of several sites, including prostate cancer. However, its relationship with cancer risk remains inconclusive. We investigated the associations between systemic inflammatory and oxidative stress markers and serum prostate specific antigen (PSA) in a cohort of presumably healthy men without any prostatic disease, aged &amp;gt;= 40 years, who participated in the U.S. National Health and Nutrition Examination Survey (NHANES), 2002-2008 (n=4,069). Methods: Serum total PSA levels and concentrations of systemic inflammatory (serum C-reactive protein [CRP], plasma fibrinogen, neutrophil count, lymphocyte count, and platelet count) and oxidative stress markers (uric acid, vitamin C, and vitamin A) were recorded. Neutrophil-lymphocyte ratio (NLR) ratio and platelet-lymphocyte (PLR) ratio were calculated. Student's t-test was used to examine whether there was any difference in the log-transformed mean of each marker between normal (&amp;lt; 4 ng/mL) versus elevated serum PSA (&amp;gt;=4 ng/mL). Logistic regression analyses were conducted to examine the association between each marker and serum PSA by calculating the odds ratio (OR) and 95% confidence interval (CI). Results: Of the 4,069 men, 259 (6.4%) of them had an elevated serum PSA (&amp;gt;=4 ng/mL). Men with elevated serum PSA had significantly higher geometric mean levels of serum CRP, plasma fibrinogen, NLR, and PLR compared to men with normal serum PSA (p-values &amp;lt;0.01). Elevated serum PSA was positively associated with plasma fibrinogen (OR= 1.79; 95% CI, 1.18-2.71) and NLR (1.17; 95% CI, 1.05-1.29), after adjustment for age, smoking, body mass index, education, race, and medications. Conclusions: Fibrinogen and NLR were associated with elevated serum PSA in men without any prostatic disease. These markers may play a role in prostate cancer risk. Future studies are needed to examine fibrinogen's and NLR's relationship with prostate cancer progression. Citation Format: Alicia C. McDonald, Manish Vira, Stephen J. Freedland, Adriana C. Vidal, Wenqi Gan, Emanuela Taioli. Associations between systemic inflammatory markers and elevated serum prostate specific antigen in men with no evidence of prostatic disease. [abstract]. In: Proceedings of the Twelfth Annual AACR International Conference on Frontiers in Cancer Prevention Research; 2013 Oct 27-30; National Harbor, MD. Philadelphia (PA): AACR; Can Prev Res 2013;6(11 Suppl): Abstract nr C32.

Dutasteride monotherapy in men with serologic relapse following radical therapy for adenocarcinoma of the prostate: A pilot study

ObjectiveThe objective of this study was to assess the effect of dutasteride on serum prostate specific antigen (PSA) levels in men with serologic relapse following radical prostatectomy and/or radiation therapy for clinically localized adenocarcinoma of the prostate. MethodsA prospective, single institution, IRB approved trial was conducted. Entry criteria required that all participants have serologic disease relapse only with serum PSA levels between 0.4 and 10.0 ng/ml. Enrolled participants were treated with 0.5 mg dutasteride daily. The primary endpoints were serum PSA level and clinical recurrence. The rate of durable decline in PSA was assessed according to the recommendations of the Prostate-Specific Antigen Working Group. ResultsThirty-five patients provided informed consent and participated in the present study. At a median follow-up duration of 27 months (range, 4–42 months), 46% of enrolled men had a serum PSA decrease of greater than 10%, and 25% had a serum PSA decrease of greater than 50% (P < 0.001). Pre-study PSA doubling time (PSADT) (≥12 months vs. <12 months), and Gleason score (≤6 vs. ≥7) were associated with a better response to dutasteride, but only PSADT was statistically significant (P < 0.001). Thirty percent of patients experienced PSA progression (increase in serum PSA of greater than 50%). Two (6%) patients developed bone metastasis. No patient was removed from the study for drug-related toxicity. ConclusionsIn the present pilot study, treatment with dutasteride resulted in a significant decrease in serum PSA in men with serologic relapse following radical treatment for adenocarcinoma of the prostate. These data appear to suggest that dutasteride may delay or prevent progression of prostate cancer in some men with biochemical relapse after radical therapy. These findings require confirmation in the setting of a larger, longer trial.

Prostate specific antigen reduction following statin therapy: Mechanism of action and review of the literature

Prostate specific antigen (PSA) is a serine protease that is exclusively produced in the prostate, and its detection is the only laboratory test available for screening men for prostate cancer (PC). The interpretation of the assay is difficult since it is specific for prostate tissue and cellular growth, but not for PC. Pharmacologic therapy for hyperlipidemia, such as statins, may influence prostate cellular growth and subsequently PSA levels in patients. Dysregulated cellular growth in the prostate is mediated by inhibiting the rate-limiting pathway step in cholesterol synthesis, thereby decreasing isoprenylate intermediates, decreasing cholesterol rich cellular membrane domains, and down-regulating androgen and estrogen receptors. Statins, with variable efficacy, have been previously shown to inhibit cellular inflammation, angiogenesis, proliferation, migration/adhesion, and invasion, while promoting apoptosis in prostate cells by inhibiting the conversion of HMG-CoA to mevalonate. An individual statin's molecular structure, need for enzymatic conversion, bioavailability, and peripheral tissue concentration may partially account for differing properties. By inhibiting prostatic cellular growth and promoting apoptosis, statins may subsequently decrease PSA levels, an effect recently observed in cohorts. There is scientific and clinical evidence supporting the observations that statins are associated with an overall reduction in serum PSA in men, when used for greater than 6 months, and especially when used for greater than 2 years.

A Double-Blind Randomized Crossover Study of Oral Thalidomide Versus Placebo for Androgen Dependent Prostate Cancer Treated With Intermittent Androgen Ablation

We determined whether thalidomide can prolong progression-free survival in men with biochemically recurrent prostate cancer treated with limited androgen deprivation therapy. A total of 159 patients were enrolled in a double-blind randomized trial to determine if thalidomide can improve the efficacy of a gonadotropin-releasing hormone agonist in hormone responsive patients with an increasing prostate specific antigen after primary definitive therapy for prostate cancer. Patients were randomized to 6 months of gonadotropin-releasing hormone agonist followed by 200 mg per day oral thalidomide or placebo (oral phase A). At the time of prostate specific antigen progression gonadotropin-releasing hormone agonist was restarted for 6 additional months. Patients were then crossed over to the opposite drug and were treated until prostate specific antigen progression (oral phase B). Testosterone and dihydroxytestosterone were likewise monitored throughout the study. During oral phase A the median time to prostate specific antigen progression was 15 months for the thalidomide group compared to 9.6 months on placebo (p = 0.21). The median time to prostate specific antigen progression during oral phase B for the thalidomide group was 17.1 vs 6.6 months on placebo (p = 0.0002). No differences in time to serum testosterone normalization between the thalidomide and placebo arms were documented during oral phase A and oral phase B. Thalidomide was tolerable although dose reductions occurred in 47% (58 of 124) of patients. Despite thalidomide having no effect on testosterone normalization, there was a clear effect on prostate specific antigen progression during oral phase B. This is the first study to our knowledge to demonstrate the effects of thalidomide using intermittent hormonal therapy.

Prostate Specific Antigen Working Group Guidelines on Prostate Specific Antigen Doubling Time

Prostate specific antigen is a glycoprotein found almost exclusively in normal and neoplastic prostate cells. Prostate specific antigen doubling time, or the change in prostate specific antigen over time, has emerged as a useful predictive marker for assessing disease outcome in patients with prostate cancer. It is important to agree on definitions and values for the calculation of prostate specific antigen doubling time, and to develop a common approach to outcome analysis and reporting. In September 2006 a conference was held at the National Cancer Institute in Bethesda, Maryland to define these parameters and develop guidelines for their use. The Prostate Specific Antigen Working Group defined criteria regarding prostate specific antigen doubling time including the calculation of prostate specific antigen doubling time, evidence to support prostate specific antigen doubling time as a predictive factor in the setting of biochemical recurrence and the use of prostate specific antigen doubling time as a stratification factor in clinical trials. We propose that investigators calculate prostate specific antigen doubling time before enrolling patients in clinical studies and calculate it as an additional measurement of therapeutic activity. We believe we have developed practical guidelines for the calculation of prostate specific antigen doubling time and its use as a measurement of prognosis and outcome. Furthermore, the use of common standards for prostate specific antigen doubling time in clinical trials is important as we determine which treatments should progress to randomized trials in which "hard" end points such as survival will be used.

Effect of 1 mg/day finasteride on concentrations of serum prostate-specific antigen in men with androgenic alopecia: a randomised controlled trial

Use of 5 mg/day finasteride (Proscar) for benign prostatic hyperplasia is known to affect serum concentrations of prostate-specific antigen (PSA). When men taking this treatment undergo screening for prostate cancer, a compensatory adjustment of the PSA concentration (to multiply the value by two) is recommended. Whether this recommendation should apply to men taking 1 mg/day finasteride (Propecia) for the treatment of androgenic alopecia is unknown. We aimed to assess the effect of 1 mg/day finasteride on serum PSA in men aged 40-60 years with male-pattern hair loss. Between March 13, 1998, and Jan 12, 2000, 355 men aged 40-60 years with male-pattern hair loss were stratified by age decade (40-49 years and 50-60 years), and randomised in a ratio of four to one to 1 mg/day finasteride or placebo. The primary endpoint was the effect of this treatment for 48 weeks on serum PSA concentration compared with placebo. This trial is in the process of being registered on the US National Institutes of Health website . Analyses were according to protocol. Within 48 weeks of randomisation, men aged 40-49 years and 50-60 years who were assigned 1 mg/day finasteride had a median decrease in serum PSA concentration of 40% (95% CI 34-46) and 50% (44-57), respectively. In men assigned placebo, the median changes were 0% [-14 to 14] and a median increase of 13% [2 to 24], respectively. In men aged 40-60 years, 1 mg/day finasteride for 48 weeks lowers serum PSA concentration. Therefore, the existing recommendation for the adjustment of serum PSA concentration in prostate-cancer screening in men taking 5 mg/day finasteride should also apply to men taking the 1 mg/day preparation for male-pattern hair loss. Research is needed to assess the effect of 1 mg/day finasteride preparation beyond 48 weeks of treatment.

Soy consumption and phytoestrogens: effect on serum prostate specific antigen when blood lipids and oxidized low-density lipoprotein are reduced in hyperlipidemic men.

Herbal remedies high in phytoestrogens have been shown to reduce serum prostate specific antigen (PSA) and have been proposed as a treatment for prostate cancer. Soy proteins used to lower serum cholesterol are rich sources of phytoestrogens. Therefore, we assessed the effect of soy consumption on serum PSA in men who had participated in cholesterol lowering studies. For 3 to 4 weeks 46 healthy middle-aged men with a range of starting PSA values took soy (mean 44 gm. soy protein daily, 116 mg. isoflavones daily) or control foods, and a subgroup of men took a lower level of soy supplements for 3 months. PSA was measured at the start and end of each treatment. Soy had no significant effect on serum total or free PSA, independent of PSA starting value or isoflavone intake. The lack of effect on PSA was seen, although soy intake was sufficient to reduce low-density lipoprotein cholesterol (5.8 +/- 2.2%, p = 0.012), the estimated coronary heart disease risk (6.1 +/- 2.8% for 10 years, p = 0.032) and the serum concentration of oxidized low-density lipoprotein measured as conjugated dienes (9.5 +/- 3.4%, p = 0.008) in the 3 to 4-week study. In addition, the lack of effect of soy on PSA persisted for the 3 months of the extended study. At levels of soy intake which reduce low-density lipoprotein cholesterol any potential benefits of soy consumption on prostate cancer are likely to occur for reasons other than alterations in hormone activity.

Natural History of Rising Serum Prostate-Specific Antigen in Men With Castrate Nonmetastatic Prostate Cancer

To describe the natural history of nonmetastatic prostate cancer and rising prostate-specific antigen (PSA) despite androgen deprivation therapy. The 201 patients in this report were the placebo control group from an aborted randomized controlled trial to evaluate the effects of zoledronic acid on time to first bone metastasis in men with prostate cancer, no bone metastases, and rising PSA despite androgen deprivation therapy. Relationships between baseline covariates and clinical outcomes were assessed by Cox proportional hazard analyses. Covariates in the model were baseline PSA, Gleason sum, history of bilateral orchiectomies, regional lymph node metastases at diagnosis, prior prostatectomy, time from androgen deprivation therapy to random assignment, time from diagnosis to random assignment, and PSA velocity. At 2 years, 33% of patients had developed bone metastases. Median bone metastasis-free survival was 30 months. Median time to first bone metastases and overall survival were not reached. Baseline PSA level greater than 10 ng/mL (relative risk, 3.18; 95% CI, 1.74 to 5.80; P < .001) and PSA velocity (4.34 for each 0.01 increase in PSA velocity; 95% CI, 2.30 to 8.21; P < .001) independently predicted shorter time to first bone metastasis. Baseline PSA and PSA velocity also independently predicted overall survival and metastasis-free survival. Other covariates did not consistently predict clinical outcomes. Men with nonmetastatic prostate cancer and rising PSA despite androgen deprivation therapy have a relatively indolent natural history. Baseline PSA and PSA velocity independently predict time to first bone metastasis and survival.

Prostatic Calculi Do Not Influence The Level of Serum Prostate Specific Antigen in Men Without Clinically Detectable Prostate Cancer or Prostatitis

Prostatic calculi are common but little is known of their effect on serum prostate specific antigen (PSA). We investigated whether prostatic calculi might influence serum PSA in men with clinically undetectable prostatic cancer or prostatitis. Between November 1999 and November 2001, 581 consecutive patients underwent serum PSA determination and digital rectal examination. Of these patients 486 without detectable prostatic cancer, or a history or symptoms of prostatitis and with other specified exclusion criteria were included in the study. The detection and volume measurement of prostatic calculi, and the measurement of prostate volume were performed by transrectal ultrasonography. Prostatic calculi were detected in 198 of the 486 men (40.7%). Mean patient age, prostate volume and serum PSA were not significantly different in men with and without prostatic calculi. Prostate volume was significantly greater in patients with abnormally elevated serum PSA than in those with normal levels. However, no significant difference was found between the percent of men with prostatic calculi or the volumes of prostatic calculi in the 2 groups. Univariate logistic regression analysis indicated that the presence or volume of prostatic calculi was not a risk factor for elevated PSA. Multivariate analysis showed that age and prostate volume were associated with elevated PSA. The presence or volume of prostatic calculi had no significant effect on serum PSA. Our results suggest that the influence of prostatic calculi is irrelevant in men with elevated PSA.

Analysis of G/A polymorphism in the androgen response element I of the PSA gene and its interactions with the androgen receptor polymorphisms

Objectives To compare the in vitro functional activity of the prostate-specific antigen (PSA) androgen response element (ARE) I alleles alone or in combination with androgen receptor (AR) polymorphisms and to determine the association of ARE I alleles with serum PSA in men without clinical prostatic disease. Data are conflicting regarding the association of PSA promoter alleles with serum PSA in men. Methods In vitro functional analyses of ARE I and AR polymorphisms were conducted by luciferase reporter assays in LNCaP and PC-3 cells. Associations among serum PSA, ARE I, and AR genotypes were determined by genotyping 109 white and 71 African-American men determined to be free of clinical prostatic disease. Results We found no significant difference in the androgen responsiveness of the two alleles when cells were transfected with PSA promoter reporter constructs differing only in the ARE I single nucleotide polymorphism and treated with varying doses of androgen. The response to androgens of the ARE I alleles co-transfected with AR expression vectors of 9, 21, and 29 CAG repeat lengths were identical. No individual or combined effects of the ARE I genotype and the AR genotype on serum PSA were noted. Conclusions Our data indicate that ARE I polymorphisms, alone or in combination with AR polymorphisms, have no functional effect on the activity of the PSA promoter in vitro and in vivo.

Soy Consumption and Phytoestrogens: Effect on Serum Prostate Specific Antigen When Blood Lipids and Oxidized Low-Density Lipoprotein are Reduced in Hyperlipidemic Men

Soy Consumption and Phytoestrogens: Effect on Serum Prostate Specific Antigen When Blood Lipids and Oxidized Low-Density Lipoprotein are Reduced in Hyperlipidemic Men

Daily variability of serum prostate-specific antigen in men over 50 years of age.

In order to investigate the variability of serum prostate-specific antigen (PSA) levels a total of 44 men 50 years or older with normal digital rectal examination were enrolled. Blood samples were obtained three times within a day, and, immediately before and 72 hours after hospitalisation. Alterations in serum PSA value during the day and after hospitalisation, which might affect clinical decision, occurred in 15% of the cases with borderline PSA values. The results indicate that there may be significant changes in serum PSA levels within a day and after hospitalisation.

Serum prostate-specific antigen as a predictor of prostate volume in men with benign prostatic hyperplasia

Objectives. To assess the utility of prostate-specific antigen (PSA) as a predictor of prostate volume by characterizing the relationship between prostate volume and serum PSA in men with symptomatic benign prostatic hyperplasia (BPH) and no evidence of prostate cancer, stratified by decade of life. Methods. Placebo-controlled multicenter trials in patients with BPH and a safety study in normal young men provided baseline measurements of serum PSA and prostate volume. The analyses included patients with a baseline prostate volume measured by either transrectal ultrasound (TRUS) or magnetic resonance imaging and baseline serum PSA. A common central laboratory was used for all but one of the individual studies; both laboratories used the Hybritech method. Patients 80 years of age or older were excluded. Patients with a baseline serum PSA greater than 10 ng/mL were excluded to reduce the likelihood of including occult prostate cancer cases. The patients in the BPH trials were screened at baseline by digital rectal examination (DRE) and serum PSA. Those with suspicious findings underwent TRUS-guided biopsy; only patients with negative biopsies are included in these analyses. Results. The analyses included 4627 patients, 4448 from the BPH trials and 179 from the safety study. The men in the BPH trials were older (mean age ± SE, 63.7 ± 0.10 years) than the men in the safety study (mean age ± SE, 30.8 ± 0.43), had larger prostates (mean volume ± SE, 43.7 ± 0.38 mL versus 26.3 ± 0.49 mL in the safety study), and had higher serum PSA values (mean ± SE, 2.6 ± 0.03 ng/mL versus 0.7 ± 0.39 ng/mL in the safety study). The relationship between prostate volume and serum PSA was evaluated using only the BPH trial data. Prostate volume and serum PSA have an age-dependent log-linear relationship (ie, their logarithms are linearly related, and the parameters of the relationship depend on age). Older men tend to have a steeper rate of increase in prostate volume with increasing serum PSA ( P < 0.001 for differences between slopes), and there was a slight tendency for PSA density to increase with age. Receiver operating characteristic (ROC) curves were constructed to evaluate the ability of serum PSA to predict threshold prostate sizes in men with BPH. The ROC curve analyses revealed that PSA had good predictive value for assessing prostate volume, with areas under the curve ranging from 0.76 to 0.78 for various prostate volume cutoff points (30, 40, and 50 mL). Conclusions. Prostate volume is strongly related to serum PSA in men with BPH and no evidence of prostate cancer, and the relationship depends on age. Since treatment outcome or risk of long-term complications depend on baseline prostate volume, serum PSA can estimate the degree of prostate enlargement sufficiently accurately to be useful for therapeutic decision making. To achieve a specificity of 70% while maintaining a sensitivity between 65% and 70%, approximate age-specific criteria for detecting men with prostate glands exceeding 40 mL are PSA >1.6 ng/mL, >2.0 ng/mL, and >2.3 ng/mL for men with BPH in their 50s, 60s, and 70s, respectively.

Predicted and actual change in serum PSA following prostatectomy for BPH

Objective. To determine the relationship between prostatic adenoma volume and serum prostate-specific antigen (PSA) levels in patients with benign prostatic hyperplasia (BPH), and to compare the predicted change in serum PSA following prostatectomy with the actual change observed. Methods. Transrectal ultrasound (TRUS) estimation of prostatic adenoma (transition zone) and total gland volumes were calculated in 96 patients prior to prostatectomy. BPH was confirmed histologically following transurethral prostatectomy (in 86) and open prostatectomy (in 10). Serum PSA was measured preoperatively in all patients and post-operatively in 87 patients. Results. Correlation coefficients of 0.607 and 0.614 were observed between PSA and adenoma and total gland volumes, respectively. The geometric mean ratio of PSA to adenoma volume was 0.120 μg/L/cc with 95% CI (0.104, 0.139) and to total gland volume was 0.068 μg/L/cc with 95% CI (0.058, 0.078). TRUS-determined adenoma and total gland volumes correlated well (r = 0.915), as did TRUS-determined adenoma volume and resected weight (r = 0.878). The mean ratio of change in PSA to resected weight was −0.096 μg/L/g with 95% CI (−0.128, −0.064). Neither total gland volume nor operation type affected the relationship between change in serum PSA and resected weight. Conclusions. The adenoma should be the main determinant of serum PSA levels in patients with BPH. TRUS adenoma volume measurement is therefore the most appropriate preoperative measure when one is interpreting elevated levels of serum PSA in men thought clinically to have BPH.