Prostate-specific Antigen Range Research Articles

A Prospective Comparison of MRI-Guided Targeted Biopsy with 12-Core Transrectal Ultrasound-Guided Systematic Biopsy in the Diagnosis of Clinically Significant Prostate Cancer: An Indian Experience

Abstract Objective The aim of this study was to compare the sensitivity and prostate cancer detection rate of magnetic resonance (MR) in-bore biopsy with transrectal ultrasound (TRUS) guided systematic biopsy. We also compared the cancer detection rate of the combined MR in-bore and TRUS-guided systematic biopsy with the TRUS-guided biopsy only approach. Methods In this prospective study, 61 consecutive patients with prostate-specific antigen (PSA) ≥ 3 ng/mL and Prostate Imaging Reporting and Data System (PI-RADS) score ≥4 were recruited between July 2017 and January 2020. One patient with prior prostate surgery was excluded. Among the remaining 60 patients, 30 underwent MR in-bore biopsy followed by systematic biopsy (study arm A) and 30 underwent systematic biopsy only (study arm B). Results The mean PSA range of study population (n = 60 patients) was 4.2 to 72.7 ng/mL. Twenty-seven patients had a PI-RADS score of 4, and 33 patients had a PI-RADS score of 5. Among 60 patients, 30 had prostate carcinoma on biopsy, of which 18 were clinically significant prostate cancers (csPCa). In study arm A, TRUS-guided systematic biopsy had a lower sensitivity (0.9) for detection of csPCa compared with MR in-bore biopsy (1.0) with overdetection of insignificant cancers (sensitivity: 0.89 vs. 0.56). TRUS-guided biopsy yielded 112 positive cores out of 360, whereas MR in-bore biopsy yielded 15 positive cores out of 30 (31.1 vs. 50%; p = 0.03). On comparison of study arms A and B, the diagnostic yield for detection of both prostate cancer and csPCa were high in study arm A (60 vs. 40%, and 33.3 vs. 26.7%, respectively) Conclusion MRI in-bore targeted biopsy had a greater sensitivity to detect csPCa with fewer number of biopsy cores and lower sensitivity to detect insignificant cancers compared with systematic biopsy. Systematic biopsies were associated with overdetection of clinically insignificant cancers.

Impact of Clinical Factors on 18F-Flotufolastat Detection Rates in Men With Recurrent Prostate Cancer: Exploratory Analysis of the Phase 3 SPOTLIGHT Study

18F-Flotufolastat (18F-rhPSMA-7.3) is a newly approved prostate-specific membrane antigen targeting radiopharmaceutical for diagnostic imaging of prostate cancer (PCa). SPOTLIGHT (National Clinical Trials 04186845) evaluated 18F-flotufolastat in men with suspected PCa recurrence. Here, we present results of predefined exploratory endpoints from SPOTLIGHT to evaluate the impact of clinical factors on 18F-flotufolastat detection rates (DR). The impact of baseline prostate-specific antigen (PSA), PSA doubling time (PSAdt), and International Society of Urologic Pathology Grade Group (GG) on 18F-flotufolastat DR was evaluated among all SPOTLIGHT patients with an evaluable scan, with DR stratified according to the patients' prior treatment (radical prostatectomy ± radiation therapy [RP] or radiation therapy only [RT]). The patients underwent positron emission tomography 50 to 70 minutes after receiving 18F-flotufolastat (296 MBq IV), and scans were read by 3 blinded central readers, with the majority read representing agreement between ≥2 readers. In total, 389 men (median PSA: 1.10 ng/mL) were evaluable. By majority read, 18F-flotufolastat identified distant lesions in 39% and 43% of patients treated with prior RP or RT, respectively. The overall DR broadly increased with increasing PSA (<0.2 ng/mL: 33%; ≥10 ng/mL: 100%). Among patients with PSA <1 ng/mL, 68% had positive scans, and 27% had extrapelvic findings. PSAdt was available for 145/389 (37%) patients. PSAdt did not appear to influence 18F-flotufolastat DR (77%-90% across all PSAdt categories). Among patients with prior RP, DR ranged from 70% to 83% across PSAdt categories, and 100% DR was reported for all post-RT patients. In total, 362/389 (93%) patients had baseline GG data. Overall DRs were uniformly high (75%‒95%) across all GG. When stratified by prior treatment, DRs across all GG were 69% to 89% in patients with prior RP and ≥96% in patients with prior RT. 18F-Flotufolastat-positron emission tomography enabled the accurate detection of recurrent PCa lesions across a wide range of PSA, PSAdt, and International Society of Urologic Pathology GG, thus supporting its clinical utility for a broad range of patients with recurrent PCa.

Validation of schedules for optimal prostate-specific antigen monitoring after radical prostatectomy.

Early detection of biochemical recurrence (BCR) after radical prostatectomy (RP) is crucial for early treatment and improving survival outcomes. The optimal prostate-specific antigen (PSA) monitoring remains unclear, and several models have been proposed. We aimed to externally validate four models for optimal PSA monitoring after RP and propose modifications to improve them. We reviewed the clinicopathological data of 896 patients who underwent robot-assisted RP between 2009 and 2022. We examined all PSA values and estimated the PSA value for four monitoring schedules at each time point in the virtual follow-up. We defined the ideal PSA for BCR detection between 0.2 and 0.4 ng/mL. During the median follow-up of 21.4 months, 128 (14.3%) patients presented BCR. The original and modified Keio models, National Cancer Center Hospital model, and American Urological Association/American Society for Radiation Oncology model detected BCR in 14 (10.9%), three (2.3%), 12 (9.4%), and 11 (8.6%) patients with PSA >0.4 ng/mL. Most patients experienced BCR detected with PSA >0.4 ng/mL during the first year postoperative. The modification of interval within 6 months postoperative avoided BCR detection with PSA >0.4 ng/mL within the first year postoperative in 8/9 (88.9%), 1/2 (50.0%), 5/6 (83.3%), and 4/4 (100%) for the original and modified Keio models, National Cancer Center Hospital model, and American Urological Association/American Society for Radiation Oncology model, respectively. We validated four models for PSA monitoring after RP to detect BCR and suggested modifications to avoid detections out of the desired range of PSA. These modifications could help to establish an optimal PSA monitoring schedule after RP.

Serum prostate-specific antigen trends and prostate cancer detection on follow-up in men with a prior negative biopsy: A cohort study

ABSTRACT Introduction: Elevated serum prostate-specific antigen (PSA) is the most common trigger for a prostate biopsy. However, the range of normal PSA is poorly defined in many populations. Men with “elevated” PSA may not harbor cancer, and it is unclear if such men with a prior negative prostate biopsy should be biopsied again. We conducted a cohort study to assess the PSA trends and cancer detection rates in such men. Methods: In an Institutional Review Board-approved ambispective study, men who underwent prostate biopsy between January 2016 and December 2021 for PSA &gt; 4 ng/mL were identified. Among them, those whose biopsy was negative for malignancy were contacted either telephonically or reviewed in person, and the most recent PSA and histopathology of any repeat prostate biopsy were determined. These were evaluated to assess the PSA trend, re-biopsy rate, and cancer detection rate. Results: During the study period, prostate biopsies were performed in a total of 1260 men; out of which 444 were negative for malignancy and 241 patients fulfilled the inclusion criteria. Their median prebiopsy PSA was 9.81 ng/mL (interquartile range [IQR]: 7.14–15.6), and the median follow-up PSA was 5.08 (IQR: 3.18–8.4). At a median follow-up of 53 months (range: 6–77 months), PSA had decreased in 177 (73.4%) patients, was static in 48 (19.9%) patients, and increased in only 16 (6.6%) patients. Repeat biopsy was performed on 20 patients; of whom seven had cancer (35%) with an overall positivity rate of 2.9% among the 241 patients. Although the positivity rate was higher in men with increased PSA, it was not statistically different from those with lower or similar PSA. No factors could be identified to predict a positive repeat biopsy. Conclusions: PSA, the sole trigger for a prostate biopsy, declined in nearly three-quarters of men with a negative first biopsy, and &lt;3% of men were detected to have cancer on a repeat biopsy. This information could help appropriately counsel patients and allay anxiety after a negative biopsy.

18F]DCFPyL PET/CT versus [18F]fluoromethylcholine PET/CT in Biochemical Recurrence of Prostate Cancer (PYTHON): a prospective, open label, cross-over, comparative study.

Primary objective was to compare the per-patient detection rates (DR) of [18F]DCFPyL versus [18F]fluoromethylcholine positron emission tomography/computed tomography (PET/CT), in patients with first prostate cancer (PCa) biochemical recurrence (BCR). Secondary endpoints included safety and impact on patient management (PM). This was a prospective, open label, cross-over, comparative study with randomized treatment administration of [18F]DCFPyL (investigational medicinal product) or [18F]fluoromethylcholine (comparator). Men with rising prostate-specific antigen (PSA) after initial curative therapy were enrolled. [18F]DCFPyL and [18F]fluoromethylcholine PET/CTs were performed within a maximum time interval of 12days. DR was defined as the percentage of positive PET/CT scans identified by 3 central imaging readers. PM was assessed by comparing the proposed pre-PET/CT treatment with the local treatment", defined after considering both PET/CTs. A total of 205 patients with first BCR after radical prostatectomy (73%; median PSA = 0.46ng/ml [CI 0.16;27.0]) or radiation therapy (27%; median PSA = 4.23ng/ml [CI 1.4;98.6]) underwent [18F]DCFPyL- and/or [18F]fluoromethylcholine -PET/CTs, between July and December 2020, at 22 European sites. 201 patients completed the study. The per-patient DR was significantly higher for [18F]DCFPyL- compared to [18F]fluoromethylcholine -PET/CTs (58% (117/201 patients) vs. 40% (81/201 patients), p < 0.0001). DR increased with higher PSA values for both tracers (PSA ≤ 0.5ng/ml: 26/74 (35%) vs. 22/74 (30%); PSA 0.5 to ≤ 1.0ng/ml: 17/31 (55%) vs. 10/31 (32%); PSA 1.01 to < 2.0ng/ml: 13/19 (68%) vs. 6/19 (32%);PSA > 2.0: 50/57 (88%) vs. 39/57 (68%) for [18F]DCFPyL- and [18F]fluoromethylcholine -PET/CT, respectively). [18F]DCFPyL PET/CT had an impact on PM in 44% (90/204) of patients versus 29% (58/202) for [18F]fluoromethylcholine. Overall, no drug-related nor serious adverse events were observed. The primary endpoint of this study was achieved, confirming a significantly higher detection rate for [18F]DCFPyL compared to [18F]fluoromethylcholine, in men with first BCR of PCa, across a wide PSA range. [18F]DCFPyL was safe and well tolerated.

A Retroprospective Clinicopathological Study of Prostatic Lesions in Surgical Specimens

Abstract Background Prostatic diseases such as inflammation, benign prostatic hyperplasia, and tumors are prime causes of mortality and morbidity in males. The prevalence of these lesions increases with advancing age. The second most common cancer among males is prostate cancer, next to lung cancer worldwide. Aim The present study was undertaken with the aim of studying the clinicopathological characteristics of prostate lesions in surgical specimens Methods The present study was a retroprospective study. A total of 212 prostate surgical specimens were included. Information provided in the requisition form regarding age, type of prostatic biopsy and clinical presentation, and histopathological diagnosis was taken into consideration and recorded. All specimens were fixed in 10% neutral buffered formalin and 5μ sections were stained with hematoxylin and eosin stain (H&amp;E stain). Relevant clinical data including age, the presenting complaints, and S.PSA values were recorded. Data were collected and analyzed using simple statistical methods with Microsoft Excel 2016. Results Out of 212 cases analyzed, 161 (76%) were transurethral resection of prostate (TURP) TUPR specimens, 38 (18%) were trucut needle biopsies, and 13 (6%) were open prostatectomy specimens. The youngest patient was 48 years old while the oldest patient was 90 years old with a mean of 71.7 ± 8.2 years. Of the total 212 surgical specimens, 174 (82%) cases were of benign prostatic hyperplasia (BHP), and 38 (18%) were prostatic adenocarcinoma (PAC). Also, 94 (44.3%) of BPH and carcinoma of the prostate cases were most common in the seventh decade of life (61-70 years). Difficulty in micturition was the most common presentation 82 (39%). A maximum number of the BPH cases 81 (46.5%) had the prostate-specific antigen range of 0 to 4 ng/mL. The highest value of serum PSA was noted among the PAC patients in the range of &gt; 80 ng/mL. Out of 38 cases of prostatic adenocarcinoma, moderately differentiated (Gleason scores 7) was the most common core and was seen in 42.1% of the PAC cases. Conclusion The present study showed that the most frequently encountered prostatic lesion was BHP, commonly seen in the age group of 61 to 70 years. The PAC was common among males of more than 60 years. Histopathological examination is the best diagnostic tool for PAC

Determination of Serum Prostate Specific Antigen Levels Amongst Apparently Healthy Nigerian Males in a University and University Hospital Community in the Federal Capital Territory.

BackgroundProstate cancer is the commonest cancer among men worldwide and serum prostate specific antigen (PSA) has remained the most commonly applied screening test for the disease till date. Current PSA test results guidelines in our population are informed by reference intervals derived from studies from Caucasians and other racial groups. With scanty data on PSA reference values from our local population, this study evaluated the serum PSA levels of apparently healthy Nigerian male subjects in whom prostate cancer and urinary tract infection have been excluded.MethodThis study had participants aged 40 to 70 years, with no lower urinary tract symptoms or other symptoms suggestive of prostate disease recruited from the male staff population of the University of Abuja and University of Abuja Teaching Hospital and the adjoining local community. They were physically examined, had prostate ultrasonography, urine analysis, and blood sample collected for PSA testing. Data collected was analyzed using Statistical Package for Social Science (SPSS) version 24.ResultOf a total of 210 men who participated in the study, 191 eventually met the inclusion criteria. The average age was 52.9 years, ninety seven percent of them had heard of prostate cancer before now. The mean total PSA was 1.46 ng/mL (SD +/−1.55), while the reference interval was .23–5.60 ng/mL. The average prostate size was 41.8 mL (SD+/-20.11), and there was a positive correlation between the PSA and the prostate size (.418) as well as the age of the subjects (.446). There was no significant difference in the mean PSA value for those with or without family history of prostate cancer (P=.979).ConclusionThe reference range of PSA in Nigeria is higher than in other races, hence utilizing a local value in decision making would help to reduce unnecessary invasive procedures.

Prevalence of Incidental Prostate Carcinoma among Patients Undergoing Turp for Benign Prostatic Enlargement

Background Incidental prostate cancer is detected by histological examination of resected biopsy tissue that has been previously diagnosed as benign. It has the potential for progressing to become a disease necessitating active treatment. There is paucity of data on detection of incidental prostate cancer in Tanzania. A study done in northern Tanzania among the urban public sector revealed an alarming detection rate of 21.71%. We aimed to establish the prevalence of incidental prostate cancer among men surgically treated for benign prostate enlargement with considered normal range of prostate specific antigen. Methods This was a retrospective hospital-based cross-sectional study conducted to establish the prevalence of incidental prostate cancer among men who underwent transurethral resection of prostate with considered normal range of prostate-specific antigen from 2010 to 2019 at Aga Khan Hospital Dar es salaam, Tanzania. To find the prevalence of incidental prostate cancer with 95% confidence level, 5% tolerable error, minimum of 195 participants’ data was reviewed, and factors associated with incidental prostate carcinoma were evaluated by binary regression analysis. Results Total of 195 men were included in the study. The prevalence of incidental prostate cancer among men with prostate-specific antigen levels of less than 5.5ng/mL was 7.2% (95% CI, 4.0 to 11.8%). More than half of the patients had high-grade cancer and three quarters had T1b histological subtype making up the clinically significant category. For every 1-year increase in age from age of 65 years, risk of incidental prostate cancer increased by 1.6 (95% CI, 1.054 to 23.38; P<0.05) and for every unit increase in prostate specific antigen, incidental prostate cancer increased by 2.2 (95% CI, 1.953 to 42.28; P<0.05). Conclusion The Incidental prostate cancer detection rate of 7.2% in our settings is within the range found internationally.

A single centre pilot experience with 18F-JK-PSMA-7 PET-CT in the staging of prostate cancer

Background: The sensitivity and specificity of bone scintigraphy and thoraco-abdominopelvic CT scans traditionally used for the staging of prostate cancer don’t meet clinical requirements. In 2020 18F-JK-PSMA-7 positron emission tomography-computed tomography (PET-CT) became available in our country for routine clinical diagnostics. Methods: As part of our self-assessment, we retrospectively analysed the results of 24 PSMA PET-CTs realised for our patients up to 31 December 2020. Results: The indication of the examination was biochemical recurrence after radical prostatectomy (prostate specific antigen (PSA) &gt;0.2 ng/mL) for 16 patients and primary staging (PSA range: 5.2–70 ng/mL) for 8 patients. Biochemical recurrence was related to local relapse in 2 cases, regional lymph node involvement in 5 cases, oligo- and multi-metastatic spread in 1 and 3 cases respectively. 5 patients had no detectable lesion. Patients with PSA &lt;1 ng/mL showed no extrapelvic enhancement. At primary staging 3 patients presented distant metastases. There was no correlation between PSA level and disease extent. In total PSMA PET-CT results changed the treatment strategy for 7 patients. Conclusions: 18F-JK-PSMA-7 PET-CT is a useful diagnostic tool. The examination can lead to change the treatment decision at primary staging as well as at biochemical recurrence. The results of this pilot study may support the strategy that patients with biochemical recurrence following radical prostatectomy receive salvage radiotherapy to the prostate bed and the pelvic lymphatic regions without any imaging examination when PSA &lt;1 ng/mL.

Comparison of whole-body bone scintigraphy with axial skeleton magnetic resonance imaging in the skeletal evaluation of carcinoma prostate.

Introduction:Whole-body bone scintigraphy (WBBS) is considered to be the standard of care in the initial skeletal evaluation of patients with carcinoma prostate. Magnetic resonance imaging (MRI) is a potential alternative technique for detecting bone metastasis. The objective of this study was to compare the diagnostic performance of WBBS with a single-photon emission computed tomography–computed tomography (SPECT-CT) correlation of the suspicious WBBS lesions to the axial skeleton (AS)-MRI in diagnosing bone metastasis in patients with carcinoma prostate.Methods:WBBS and AS-MRI were both performed during the initial skeletal evaluation in 35 patients of carcinoma prostate with the prostate-specific antigen (PSA) in the range of 10–50 ng/ml. Suspicious lesions on the WBBS were correlated on SPECT CT. The presence or absence of metastasis was determined by best valuable comparator. The validity parameters of WBBS and AS-MRI were computed and compared.Results:The sensitivity, specificity, positive predictive value, and negative predictive value of WBBS and AS-MRI for detecting patients with bone metastasis were 55.6%, 88.5%, 62.5%, 85.2% and 100.0%, 96.2%, 90.0%, 100%, respectively. The kappa value and the accuracy of WBBS were 0.457 and 80.0%, respectively. The kappa value and accuracy of AS-MRI were 0.928 and 97.1%, respectively.Conclusions:The diagnostic performance of AS-MRI in detecting patients with bone metastasis due to carcinoma prostate is superior to that of WBBS with SPECT-CT correlation of the suspicious lesions in the PSA range of 10–50 ng/ml.

Prediction models for prostate cancer to be used in the primary care setting: a systematic review

ObjectiveTo identify risk prediction models for prostate cancer (PCa) that can be used in the primary care and community health settings.DesignSystematic review.Data sourcesMEDLINE and Embase databases combined from inception and...

Development and evaluation of the MiCheck test for aggressive prostate cancer

BackgroundA clinical need exists for a biomarker test to accurately delineate aggressive prostate cancer (AgCaP), and thus better assist clinicians and patients decision-making on whether to proceed to prostate biopsy. ObjectivesTo develop a blood test for AgCaP and compare to PSA, %free PSA, proPSA, and prostate health index (PHI) tests. Design, settings and participantsPatient samples from the MiCheck-01 trial were used for development of the MiCheck test. MethodsSerum analyte concentrations for cellular growth factors were determined using a custom-made Luminex-based R&D Systems multianalyte kit. Outcome measurements and statistical analysisBayesian model averaging and random forest approaches were used to identify clinical factors and growth factors able to distinguish between men with AgCaP (Gleason Score [GS] ≥3+4) from those with non-AgCaP (GS 3+3). Logistic regression and Monte Carlo cross-validation identified variable combinations in order to able to maximize differentiation of AgCaP from non-AgCaP. ResultsThe MiCheck logistic regression model was developed and comprises the following variables: serum prostate-specific antigen (PSA), patient age, Digital Rectal Exam (DRE) status, Leptin, IL-7, vascular endothelial growth factor, and Glypican-1. The model differentiated AgCaP from non-AgCaP with an area under the curve of 0.83 and was superior to PSA, %free PSA and PHI in all patient groups, regardless of PSA range. Applying the MiCheck test to all evaluable biopsy patients from the MiCheck-01 study demonstrated that up to 30% of biopsies could be avoided while delaying diagnosis of only 6.8% of GS ≥3+4 cancers, 5% of GS ≥4+3 cancers and no cancers of GS 8 or higher. ConclusionsThe MiCheck test outperforms PSA, %free PSA and PHI tests in differentiating AgCaP vs. non-AgCaP patients. The MiCheck test could result in a significant number of biopsies being avoided with a low number of patients experiencing a delayed diagnosis.

External validation of the "optimal PSA follow-up schedule after radical prostatectomy" in a new cohort.

Biochemical recurrence (BCR) after radical prostatectomy (RP) is most commonly diagnosed by detecting an increase in asymptomatic prostate-specific antigen (PSA). We previously reported the "optimal PSA follow-up schedule after RP". The aim of this study was to confirm the usefulness and safety of that follow-up schedule in another cohort. We retrospectively reviewed the clinicopathological data of 798 consecutive patients who underwent radical prostatectomy between 2009 and 2017. We examined all PSA values measured during follow-up. Furthermore, we estimated the PSA value when we observed the "optimal PSA follow-up schedule" at each timing in the virtual follow-up. BCR was defined as an elevation of PSA to greater than 0.2ng/ml, and the ideal PSA range for detection of BCR was regarded to be 0.2-0.4ng/ml. During the mean follow-up period of 5.8years, BCR occurred in 115 (14.9%) patients and the frequency of virtual follow-up was significantly lower than the actual frequency. However, overlooking of BCR (detecting BCR when PSA exceeded 0.4ng/ml) was observed in 17 patients, which is higher than the actual frequency of overlooking (12 patients). Therefore, we modified the follow-up schedule, which could achieve the lower follow-up frequency and a limited number of overlooking of BCR (7 patients). This external validation study revealed that the "modified optimal PSA follow-up schedule after RP" can reduce the frequency of PSA measurement with a limited risk of overlooking BCR.

Diagnostic Impacts of Clinical Laboratory Based p2PSA Indexes on any Grade, Gleason Grade Group 2 or Greater, or 3 or Greater Prostate Cancer and Prostate Specific Antigen below 10 ng/ml.

The PROPHET (Prostate Cancer: Prostate Health Index Trial) is a prospective study to clarify the diagnostic impact of laboratory based and prostate volume adjusted p2PSA ([-2] proenzyme prostate specific antigen) related indexes on prostate cancer and clinically significant prostate cancer with prostate specific antigen less than 10 ng/ml. Between April 2015 and March 2017, 421 men 50 to 79 years old in the prostate specific antigen range above age specific cutoffs and below 10 ng/ml were registered in the PROPHET. We investigated the diagnostic impacts of various clinical laboratory based free prostate specific antigen related and p2PSA related indexes on any grade and high Gleason grade group prostate cancer. Of the 363 eligible participants 179, 141 and 80 were diagnosed with any grade, and Gleason Grade Group 2-5 and 3-5 prostate cancer, respectively. The AUC-ROCs distinguishing nonprostate cancer vs prostate cancer, nonprostate cancer plus low Gleason Grade Group and low volume vs remaining prostate cancer with a higher Gleason Grade group or a higher volume on the PHI (Prostate Health Index) were significantly superior to the AUC-ROCs of prostate specific antigen and free-to-total prostate specific antigen. At 90% sensitivity in all investigated p2PSA related indexes the false-positive rate was superior to that of prostate specific antigen and free-to-total prostate specific antigen in any group comparison in terms of the Gleason Grade Group and positive biopsy cores. In 35% to 42% of men without prostate cancer and/or those with less aggressive prostate cancer the PHI would avoid unnecessary biopsy. Laboratory based p2PSA related indexes were significantly superior for detecting clinically significant prostate cancer compared to free-to-total prostate specific antigen. The indexes those would avoid up to 42% of prostate biopsies in men without aggressive cancer while maintaining 90% sensitivity.

Role of prostatic specific antigen density and its correlation with histopathology in diagnosis of the carcinoma of prostrate

Background: The specific threshold for prostate-specific antigen (PSA) to delineate patients who are at the highest risk has been controversial. It is wiser to refine PSA by its derivative parameter like PSAD (PSA/vol) which can be used as a better diagnostic tool in early detection of carcinoma of prostrate. To evaluate sensitivity and specificity of PSAD in diagnosis of carcinoma of prostrate.Methods: A study including 70 patients was done in Pravara Medical College and Rural Hospital, Loni. Patients were screened for prostatic diseases by DRE, blood PSA (ng/ml) estimation, prostatic volume by transabdominal ultrasonography and prostatic biopsy by FNAC or Tru cut Biopsy.Results: In the present study maximum incidence of BPH and CaP manifested in the age group of 61-70 (i.e., 35.18%) and Ca prostate were in age group of 71-80 (i.e., 50%). The maximum number of patients with BPH were having PSA values between 3-10 ng/ml, where as in CaP the value varied between 10.1-20 ng/ml. The maximum number of patients were in the range of 3-10 ng/ml in which age group 61-70 were having highest (35.71% of the pts in that range) followed by PSA range 10.1-20 ng/ml in which, age group 71-80 have shown maximum number (54.54% of the pts in that range) . The sensitivity, specificity, accuracy of PSAD in diagnosing malignant prostatic diseases were analysed and values were as follows: sensitivity: 87.50%, specificity: 92.59%.Conclusions: It was concluded that patients with PSAD &gt;0.15 can be advised for prostatic biopsy and regular follow so that appropriate treatment is performed and mortality due to prostatic malignancy is reduced.

Internal Validation and Correlation of 2 Different Prostate Specific Antigen Assays for Prostate Cancer Screening in Community Based Men.

There are more than 20 prostate specific antigen assays in use in the United States and studies have been mixed regarding correlations among them. The Abbott ARCHITECT Total PSA and the Roche Modular Analytics E170 Total PSA have been used in 2 local hospital systems that recently merged. We defined the comparability of these assays and present it from a clinical perspective. A prospective review of men 45 years old or older who underwent serum prostate specific antigen testing at our facilities was performed. Specimens were processed using both assays. Inclusion criteria were prostate specific antigen values obtained from March 1 to June 1, 2014. Prostate specific antigen values that were undetectable by either assay were excluded from study. The data were explored using regression analysis. Of 441 serum samples collected 414 fit the inclusion criteria. The data were stratified by prostate specific antigen 0 to 4 (367), 1.5 to 4.0 (107), 2.5 to 4.0 (48), 4.01 to 10 (33) and greater than 10 ng/ml (14). Regression analysis of the overall data yielded an R2 of 0.997 (SE 1.657). The subgroup analysis for each respective range showed R2 values of 0.974 (SE 0.15), 0.889 (SE 0.25), 0.677 (SE 0.25), 0.852 (SE 0.65) and 0.986 (SE 2.22). In general the prostate specific antigen range of most concern in prostate cancer screening is 4.01 to 10 ng/ml. Our data show an 85% correlation between the assays within this range. This relationship is too weak to recommend interchanging the tests with confidence. Additionally, we describe a successful model when combining laboratories using disparate assays.

Feasibility of prostatectomy without prostate biopsy in the era of new imaging technology and minimally invasive techniques.

BACKGROUNDRoutinely, after receiving prostate specific antigen (PSA) testing and digital rectum examination, patients with suspected prostate cancer are required to undergo prostate biopsy. However, the ability of ultrasound-guided prostate biopsy to detect prostate cancer is limited. Nowadays, a variety of diagnostic methods and more sensitive diagnostic methods, such as multi-parameter prostate magnetic resonance imaging (mpMRI) and prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) can be applied clinically. Furthermore, laparoscopic/robot-assisted prostatectomy is also a safe and effective procedure for the treatment of benign prostatic hyperplasia. So maybe it is time to reconsider the necessary to perform prostate biopsy before radical prostatectomy.AIMTo explore the feasibility of radical prostatectomy without prostate biopsy in the era of new imaging technology and minimally invasive techniques.METHODSFrom June 2014 to November 2018, 11 cases of laparoscopic radical prostatectomy without prostate biopsy were performed at the three tertiary medical centers involved in this study. All patients received prostate magnetic resonance imaging and prostate cancer was suspected, including six patients with positive 68Ga-PSMA PET/CT results. Laparoscopic radical prostatectomy and pelvic lymph node dissection were performed for all patients.RESULTSAll surgeries were accomplished successfully. The mean age was 69 ± 7.7 year, the mean body mass index was 24.7 ± 1.6 kg/m2, the range of serum PSA was 4.3 to >1000 ng/mL, and the mean prostate volume was 40.9 ± 18.3 mL. The mean operative time was 96 ± 23.3 min, the mean estimated blood loss was 90 ± 90.9 mL, and the median duration of catheter placement was 14 d. The final pathology confirmed that all specimens were prostate cancer except one case of benign prostatic hyperplasia. No major complications occurred in 90 d postoperatively.CONCLUSIONThe current practice of mandating a prostatic biopsy before prostatectomy should be reconsidered in the era of new imaging technology and minimally invasive techniques. Radical prostatectomy could be carried out without the evidence of malignancy. Large-sample randomized controlled trials are definitely required to confirm the feasibility of this new concept.

Emissions of terbium metal-organic frameworks modulated by dispersive/agglomerated gold nanoparticles for the construction of prostate-specific antigen biosensor.

Herein, a universal and multifunctional fluorescence sensor platform is designed by the interaction of aggregation/dispersion gold nanoparticles (AuNPs) with Tb-metal-organic frameworks (Tb-MOFs). It is found that the dispersed AuNPs rather than the aggregated ones can quench effectively the fluorescence of Tb-MOFs, and the quenching process presumably involves the mechanism of inner filter effect (IFE), dynamic quenching effect (DQE), and fluorescence resonance energy transfer (FRET). The different affinities of aptamer and aptamer-target complex toward AuNPs are employed to modulate the fluorescence signal change of Tb-MOFs. As the proof of concept, prostate-specific antigen (PSA), an efficient tumor indicator for prostate cancer, is selected as the target. At first, the PSA aptamer can protect AuNPs against salt-induced aggregation, leading to the fluorescence of Tb-MOFs quenching. Subsequently, upon PSA introduction, the rigid aptamer-PSA complex is formed and cannot stabilize AuNPs in high salt conditions, so the AuNPs aggregate significantly and the fluorescence of Tb-MOFs is restored. The linear range of PSA is achieved from 1 to 100ng/mL with a detection limit of 0.36ng/mL. Finally, this method has been validated to be sensitive and specific for PSA in human urine samples. Graphical abstract.

Population pharmacokinetic–pharmacodynamic modelling of the relationship between testosterone and prostate specific antigen in patients with prostate cancer during treatment with leuprorelin

This investigation aimed to quantitatively characterize the relationship between the gonadotropin-releasing hormone agonist leuprorelin, testosterone (T) and prostate specific antigen (PSA) concentrations over time, to aid identification of a target T concentration that optimises the balance of the benefits of T suppression whilst reducing the risk of side effects related to futile over-suppression. Data from a single dose study to investigate the effect of leuprorelin in a 6-month depot formulation on T and PSA in prostate cancer patients were analysed using a population pharmacokinetic-pharmacodynamic modelling approach. The developed model was qualified using external data from 3 studies, in which the effect of different formulations of leuprorelin on T and PSA was evaluated in prostate cancer patients. The effect of leuprorelin on the relationship between T and PSA was adequately characterized by the Romero model with minor modifications, combined with a turnover model to describe the delay in response between T and PSA. The data were significantly better described when assuming a minimum PSA level that is independent on the treatment-related reduction in T, as compared to a model with a proportional reduction in PSA and T. The model-based analysis suggests that on a population level, reducing T concentrations below 35ng/dL does not result in a further decrease in PSA levels (>95% of the minimal PSA level is reached). More data are required to support this relationship in the lower T and PSA range.

11C-choline PET/CT predicts survival in prostate cancer patients with PSA < 1 NG/ml.

The main drawback of 11C-choline PET/CT for restaging prostate cancer (PCa) patients with biochemical failure is the relatively low positive detection rate for prostate specific antigen (PSA) < 1ng/ml. This study assessed whether 11C-choline PET/CT predicts survival in PCa patients with PSA < 1ng/ml. This retrospective study included 210 PCa patients treated with radical prostatectomy who underwent 11C-choline PET/CT from December 1, 2004 to July 31, 2007 due to biochemical failure. PCa-specific survival was estimated using Kaplan-Meier curves. Cox regression analysis was used to evaluate the association between clinicopathologic variables and PCa-specific survival. PCa-specific survival was computed as the interval from radical prostatectomy to PCa-specific death. Median follow-up after radical prostatectomy was 6.9years (95% confidence interval, CI, 2.0-14.5years). 11C-choline PET/CT was positive in 20.5% of patients. Median PCa-specific survival was 13.4years (95% CI, 9.9-16.8years) in patients with positive 11C-choline PET/CT, and it was not achieved in patients with negative 11C-choline PET/CT (log-rank, chi-square = 15.0, P < 0.001). Ten-year survival probabilities for patients with negative 11C-choline PET/CT and for patients with positive 11C-choline PET/CT were 86.0% (95% CI: 80.7%-91.3%) and 63.6% (95% CI: 54.5-72.7%). At multivariate analysis, only 11C-choline PET/CT significantly predicted PCa-specific survival (hazard ratio = 2.54, 95% CI, 1.05-6.13, P =0.038). Patients with pathological 11C-choline uptake in the prostatic bed or in pelvic lymph nodes had longer PCa-specific survival in comparison to patients with pathological tracer uptake in the skeleton (log-rank: chi-square = 27.4, P < 0.001). Despite the relatively low positive detection rate for PSA < 1ng/ml, positive 11C-choline PET/CT predicts PCa-specific survival in this low PSA range. As long as more sensitive radiotracers, such as 68Ga-PSMA-11, do not become more widely available, these results might support a broader use of radiolabeled choline in restaging PCa for PSA < 1ng/ml.