One and done?: Utility of PSA density as a predictor of number of cores needed to detect clinically significant prostate cancer.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 104-104
Author(s):  
Graham Hale ◽  
Jonathan Bloom ◽  
Amir H Lebastchi ◽  
Samuel A Gold ◽  
Sherif Mehralivand ◽  
...  

104 Background: MRI/US fusion guided prostate biopsy (FBx) has been shown to detect clinically significant prostate cancer (csCaP) at higher rates and with fewer cores than standard prostate biopsy. However, the number of targeted cores needed to accurately characterize lesions identified on multiparametric MRI (mpMRI) is unknown. This study sought to determine factors that predict the number of cores needed to accurately characterize lesions during FBx of patients on active surveillance. Methods: A retrospective analysis of a prospectively maintained database of all patients undergoing FBx at an academic referral center between May 2014 and January 2018 was conducted. At least two FBx cores were taken from each lesion identified on mpMRI. Patient and lesion specific factors were analyzed to determine factors that predict the necessity to obtain additional cores to detect csCaP. GEE-based univariate logistic regression model with exchangeable correlation was used to estimate the effects of clinical characteristics including race, BMI, PSA, PSA density (PSAD), lesion location, and PI-RADS score on the proportion of positive and negative agreement. Predictability of a significant continuous predictor was quantified by AUC. The most significant patient-level predictor (PSAD) was further analyzed to determine thresholds at which multiple cores per lesion are needed to avoid missing csCaP. Results: An analysis of a total of 1141 FBx were performed during the study time interval. PSA (OR=1.57, 1.20-2.05, p<0.01) and PSAD (OR=1.43, 1.11-1.85, p<0.01) significantly predicted positive agreement of csCaP. AUC for positive and negative agreement was 57.4 and 61.0 for PSA and 56.4 and 72.3 for PSAD, respectively. Using these thresholds, only 56% lesions would need double core targeted biopsy. In other words, up to 44% of lesions would be accurately characterized with a single biopsy core of the targeted lesion. Conclusions: These data indicate that in patients with a PSAD less than 0.11 ng/ml2 or greater than 0.26 ng/ml2, lesions may be acceptably characterized with a single targeted biopsy core.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 283-283
Author(s):  
Amir H. Lebastchi ◽  
Luke P. O'Connor ◽  
Alex Z. Wang ◽  
Nitin Yerram ◽  
Sandeep Gurram ◽  
...  

283 Background: MRI/US fusion guided prostate biopsy (FBx) has been shown to detect clinically significant prostate cancer (csCaP) at higher rates and with fewer cores than standard prostate biopsy. Size plays an important role in assigning a suspicion level (PI-RADS) to lesions identified on MRI. However, tumor characteristics may pose challenges to accurately characterizing the lesion despite the size. This study sought to determine if there are size cutoffs at which a lesion may be accurately characterized as clinically significant cancer with a single biopsy core. Methods: A retrospective analysis of a prospectively maintained database of all patients undergoing FBx at an academic referral center between May 2014 and January 2018 was conducted. At least two FBx cores were taken from each lesion identified on mpMRI. GEE-based univariate logistic regression model with exchangeable correlation was used determine if size was a significant predictor of positive and negative agreement. Predictability of size as a significant continuous predictor was quantified by AUC. Size thresholds at which multiple cores per lesion are needed to avoid missing > 2% of csCaP were calculated, allowing for a 25% discordance rate. Results: An analysis of a total of 1141 FBx of 2200 lesions was performed during the study time interval. Size was a significant predictor of both positive (OR = 2.43, 1.83-3.23, p < 0.01) and negative (OR = 0.58, 0.44-0.76, p < 0.01) agreement of csCaP. AUC% for positive and negative agreement was 65.8 and 57.6, respectively. Size thresholds of 0.65 and 1.70 cm limited CS cancers missed by skipping a second targeted biopsy core to 2% while allowing for a 25% discordance. Conclusions: These data indicate that clinically significant prostate cancer in lesions less than 0.65 cm and greater than 1.70 cm may be characterized with a single targeted biopsy core, sparing 33.5% of lesions (21% patients) a double core targeted biopsy.


2021 ◽  
Vol 11 ◽  
Author(s):  
Salvatore M. Bruno ◽  
Ugo G. Falagario ◽  
Nicola d’Altilia ◽  
Marco Recchia ◽  
Vito Mancini ◽  
...  

The association between PSA density, prostate cancer (PCa) and BPH is well established. The aim of the present study was to establish whether PSA density can be used as a reliable parameter to predict csPCa and to determine its optimal cutoff to exclude increased PSA levels due to intraprostatic inflammation. This is a large prospective single-center, observational study evaluating the role of PSA density in the discrimination between intraprostatic inflammation and clinically significant PCa (csPCa). Patients with PSA ≥ 4 ng/ml and/or positive digito-rectal examination (DRE) and scheduled for prostate biopsy were enrolled. Prostatic inflammation (PI) was assessed and graded using the Irani Scores. Multivariable binary logistic regression analysis was used to assess if PSA density was associated with clinically significant PCa (csPCa) rather than prostatic inflammation. A total of 1988 patients met the inclusion criteria. Any PCa and csPCa rates were 47% and 24% respectively. In the group without csPCa, patients with prostatic inflammation had a higher PSA (6.0 vs 5.0 ng/ml; p=0.0003), higher prostate volume (58 vs 52 cc; p&lt;0.0001), were more likely to have a previous negative biopsy (29% vs 21%; p=0.0005) and a negative DRE (70% vs 65%; p=0.023) but no difference in PSA density (0.1 vs 0.11; p=0.2). Conversely in the group with csPCa, patients with prostatic inflammation had a higher prostate volume (43 vs 40 cc; p=0.007) but no difference in the other clinical parameters. At multivariable analysis adjusting for age, biopsy history, DRE and prostate volume, PSA density emerged as a strong predictor of csPCA but was not associated with prostatic inflammation. The optimal cutoffs of PSA density to diagnose csPCa and rule out the presence of prostatic inflammation in patients with an elevated PSA (&gt;4 ng/ml) were 0.10 ng/ml2 in biopsy naïve patients and 0.15 ng/ml2 in patients with a previous negative biopsy. PSA density rather than PSA, should be used to evaluate patients at risk of prostate cancer who may need additional testing or prostate biopsy. This readily available parameter can potentially identify men who do not have PCa but have an elevated PSA secondary to benign conditions.


2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 150-150
Author(s):  
Cayce Nawaf ◽  
James Rosoff ◽  
Jeffrey Weinreb ◽  
Amanda Lu ◽  
Angelique Levi ◽  
...  

150 Background: Results from 12-core template mapping biopsy (Mbx) and concurrent MRI-US fusion targeted biopsy (Tbx) were compared in 118 men without prior biopsy. Methods: Between 12/2012 and 06/2015, 374 men with an indication for prostate biopsy presented to our institution and underwent pre-biopsy mpMRI followed by 12-core standard trans-rectal mapping biopsy (Mbx) and MRI-Ultrasound fusion targeted biopsy (Tbx) of lesions identified on mpMRI. The combination of Mbx and Tbx, when both occurred, constitutes a fusion biopsy (Fbx). Men who underwent both Mbx with or without Tbx using the Artemis/Pro-Fuse system with no previous biopsy were included. Patients without a lesion on MRI underwent Mbx only. Maximum Gleason scores (GS) was assigned on a per patient basis with Mbx GS available for all patients in the cohort and Tbx GS available only for patients with a lesion visible on MP-MRI. Clinically significant (CS) was defined as GS ≥3+4. GS per patient was compared by chi-square and McNemar’s test. Results: 118 men met inclusion criteria (mean age=64.9, mean PSA=11.5). Prostate cancer was detected in 64 (54%) Fbx cases. Cancer detection rates for Mbx and Tbx were 54% and 57%, respectively. In patients where Fbx identified CS cancer, Tbx was more likely to have identified the cancer than Mbx (96% vs 72%; p < 0.001). Fewer GS 6 cancers were detected by Tbx (n=7) than by Mbx (n=25), and Tbx alone would have prevented the detection of 21 (18%) cases of GS 6 disease. Conversely, more GS≥ 7 (50% of men) was detected on Tbx than on Mbx (33% of men). In total, there were 16 patients (13.5%) that were missed or understaged by Tbx, but only 4 of these patients (3%) were GS≥ 7. In contrast, there were 19 (16%) patients that were missed or understaged by Mbx, but 17 (14%) of these 19 patients harbored GS≥ 7 disease. Conclusions: In biopsy-naive men who are suspected to have prostate cancer, Tbx provides improved detection of CS prostate cancer compared with Mbx while decreasing the detection of low-grade disease. Tbx alone in biopsy-naive men should be considered if missing 3% of CS disease is acceptable. [Table: see text]


2019 ◽  
Vol 18 (1) ◽  
pp. e1802-e1803
Author(s):  
P. Dell’Oglio ◽  
A. Stabile ◽  
L. Boeri ◽  
M. Soligo ◽  
G. Rosiello ◽  
...  

Medicina ◽  
2021 ◽  
Vol 57 (1) ◽  
pp. 57
Author(s):  
Alvydas Vėželis ◽  
Gediminas Platkevičius ◽  
Marius Kinčius ◽  
Liutauras Gumbys ◽  
Ieva Naruševičiūtė ◽  
...  

Background and objectives: Overdiagnosis, overtreatment, and the need for repeated procedures caused by transrectal ultrasound guided prostate biopsies and their related complications places a heavy burden on healthcare systems. This was a prospective cohort validating study to access the clinical accuracy of systematic and MRI-cognitive targeted transperineal prostate biopsies in detecting clinically significant prostate cancer after a previous negative biopsy and persistent suspicion of malignancy. The primary goal was to assess the ability of multiparametric magnetic resonance imaging (mpMRI) to detect clinically significant prostate cancer with an additional goal to assess the diagnostic value of systematic and MRI-cognitive transperineal biopsies. Materials and Methods: In total, 200 patients were enrolled who had rising serum prostate specific antigen (PSA) levels for at least 4 months after a previous negative transrectal ultrasound (TRUS) biopsy. All eligible men underwent 1.5T prostate mpMRI, reported using the Prostate Imaging Reporting and Data System version 2 (PI-RADS v2), followed by a 20-region transperineal prostate systematic biopsy and additional targeted biopsies. Results: Systematic 20-core transperineal prostate biopsies (TPBs) were performed for 38 (19%) patients. Systemic 20-core TPB with additional cognitive targeted biopsies were performed for 162 (81%) patients. Clinically significant prostate cancer (csPC) was detected for 31 (15.5%) patients, of which 20 (64.5%) cases of csPC were detected by systematic biopsy, eight (25.8%) cases were detected by targeted biopsy, and three (9.7%) both by systematic and targeted biopsies. Conclusions: Cognitive mpMRI guided transperineal target biopsies increase the detection rate of clinically significant prostate cancer after a previously negative biopsy. However, in a repeat prostate biopsy setting, we recommend applying a cognitive targeted biopsy with the addition of a systematic biopsy.


2019 ◽  
Vol 201 (Supplement 4) ◽  
Author(s):  
Paolo Dell'Oglio* ◽  
Armando Stabile ◽  
Luca Boeri ◽  
Antonio Esposito ◽  
Matteo Soligo ◽  
...  

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 88-88
Author(s):  
Cayce Nawaf ◽  
James Rosoff ◽  
Amanda Lu ◽  
Jeffrey Weinreb ◽  
Peter Humphrey ◽  
...  

88 Background: Appropriate risk stratification of men on active surveillance for prostate cancer is essential to identify men in whom it is safe to take this deferred treatment approach. This study evaluates upstaging rates using MRI-US fusion targeted biopsy in men who have had a prior positive standard 12-core biopsy. Methods: Between 12/2012 and 06/2015, 374 men with an indication for prostate biopsy underwent pre-biopsy mpMRI followed by 12-core standard trans-rectal mapping biopsy (Mbx) and MRI-Ultrasound fusion targeted biopsy (Tbx) of lesions identified on mpMRI. The combination of Mbx and Tbx, when both occurred, constitutes a fusion biopsy (Fbx). Men who underwent both Mbx with or without Tbx using the Artemis/Pro-Fuse system with a previous non-MRI-guided biopsy and a diagnosis of prior Gleason 6 prostate cancer were included. Patients without a lesion on MRI underwent Mbx only. Maximum Gleason scores (GS) were assigned on a per patient basis with Mbx GS available for all patients in the cohort and Tbx GS available only for patients with a lesion visible on MP-MRI. Clinically significant (CS) cancer was defined as GS ≥ 3+4. GS per patient was compared by chi-square and McNemar’s test. Results: 118 patients met inclusion criteria (Mean PSA = 6.9, Mean age = 62.5). 40 patients (34%) were upstaged by Fbx to Gleason ≥ 7. Of those upstaged, 17 men (14%) would have been missed by Mbx alone, in comparison to 7 (6%) that were missed by Tbx alone. Total number of prior biopsies (p = 0.28) and number of years on Active Surveillance (p = 0.22) were not related to upgrade on Fbx. Older men (65.3 vs. 60.9, p = 0.033) and those with higher PSA (8.7 vs 5.8, p = 0.002) were more likely to be upgraded on Fbx. Tbx was more likely to identify CS cancer than Mbx (85% vs 56%; p < 0.012). Conclusions: MP-MRI Fusion biopsy more accurately stratifies men with a previous prostate biopsy than those receiving a template mapping 12-core biopsy alone. Tbx should be strongly considered before enrolling a patient in active surveillance since up 14% of clinically significant cancer would have been missed with a 12-core biopsy alone. [Table: see text]


2021 ◽  
Vol 9 (8) ◽  
Author(s):  
Kai Zhang ◽  
Zijian Song ◽  
S. Remmers ◽  
Rui Chen ◽  
Gang Zhu ◽  
...  

Objective To evaluate the performance of the systematic (SBx) and targeted prostate biopsy (TBx) in detecting prostate cancer (PCa) and significant prostate cancer (csPCa) and including upfront risk stratification with PSA Density (PSAD) in a biopsy naïve cohort of Chinese men. Methods A total of 348 men from two medical centers were available for analyses. All men underwent a mpMRI scan based on an elevated PSA and/or abnormal digital rectal examination (DRE). A total of 150 men received both SBx and TBx prostate biopsy (PIRADS >= 3). In these men the detection ratio was calculated as the PCa and csPCa prevalence of the TBx strategy divided by the prevalence of PCa and csPCa of the SBx + TBx strategy. For PSAD analyses the percentage missed csPCa were plotted against the clinically relevant thresholds of PSAD (range 0.01 – 0.20). Results In the men with PIRADS >= 3, a total of 89 PCa cases (59 being csPCa) were detected. The TBx alone strategy detected 74 of all PCa, leading to a detection ratio of 0.83 (95% CI 0.74-0.90). For csPCa these numbers were 48 of the total 59 csPCa cases, i.e a detection ratio of 0.81 (95% CI 0.69-0.90).With the focus on avoiding missing csPCa diagnoses a cut-off of PSA D 0.10 seemed optimal in this cohort, leading to a reduction of 15% of all referrals, missing 6% of all PCa and 2% of csPCa. A similar cut-off of PSAD holds if also men with PIRADS >= 2 were included. Conclusion In this Chinese cohort of biopsy naïve men a TBx approach can aid in improved detection of csPCa. Omitting SBx would results in missing csPCa cases. An upfront risk stratification step with the use of PSAD is advised although the optimal PSAD cut-off in Asian men most likely differs from the generally advised cut-off of 0.15 ng/ml/ml.


Cancers ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 1985
Author(s):  
Hayley Pye ◽  
Saurabh Singh ◽  
Joseph M. Norris ◽  
Lina M. Carmona Echeverria ◽  
Vasilis Stavrinides ◽  
...  

Objectives: To assess the clinical outcomes of mpMRI before biopsy and evaluate the space remaining for novel biomarkers. Methods: The INNOVATE study was set up to evaluate the validity of novel fluidic biomarkers in men with suspected prostate cancer who undergo pre-biopsy mpMRI. We report the characteristics of this clinical cohort, the distribution of clinical serum biomarkers, PSA and PSA density (PSAD), and compare the mpMRI Likert scoring system to the Prostate Imaging–Reporting and Data System v2.1 (PI-RADS) in men undergoing biopsy. Results: 340 men underwent mpMRI to evaluate suspected prostate cancer. 193/340 (57%) men had subsequent MRI-targeted prostate biopsy. Clinically significant prostate cancer (csigPCa), i.e., overall Gleason ≥ 3 + 4 of any length OR maximum cancer core length (MCCL) ≥4 mm of any grade including any 3 + 3, was found in 96/195 (49%) of biopsied patients. Median PSA (and PSAD) was 4.7 (0.20), 8.0 (0.17), and 9.7 (0.31) ng/mL (ng/mL/mL) in mpMRI scored Likert 3,4,5 respectively for men with csigPCa on biopsy. The space for novel biomarkers was shown to be within the group of men with mpMRI scored Likert3 (178/340) and 4 (70/350), in whom an additional of 40% (70/178) men with mpMRI-scored Likert3, and 37% (26/70) Likert4 could have been spared biopsy. PSAD is already considered clinically in this cohort to risk stratify patients for biopsy, despite this 67% (55/82) of men with mpMRI-scored Likert3, and 55% (36/65) Likert4, who underwent prostate biopsy had a PSAD below a clinical threshold of 0.15 (or 0.12 for men aged <50 years). Different thresholds of PSA and PSAD were assessed in mpMRI-scored Likert4 to predict csigPCa on biopsy, to achieve false negative levels of ≤5% the proportion of patients whom who test as above the threshold were unsuitably high at 86 and 92% of patients for PSAD and PSA respectively. When PSA was re tested in a sub cohort of men repeated PSAD showed its poor reproducibility with 43% (41/95) of patients being reclassified. After PI-RADS rescoring of the biopsied lesions, 66% (54/82) of the Likert3 lesions received a different PI-RADS score. Conclusions: The addition of simple biochemical and radiological markers (Likert and PSAD) facilitate the streamlining of the mpMRI-diagnostic pathway for suspected prostate cancer but there remains scope for improvement, in the introduction of novel biomarkers for risk assessment in Likert3 and 4 patients, future application of novel biomarkers tested in a Likert cohort would also require re-optimization around Likert3/PI-RADS2, as well as reproducibility testing.


2020 ◽  
Vol 22 (12) ◽  
pp. 69-73
Author(s):  
Artem V. Okishev ◽  
◽  
Alexander V. Govorov ◽  
Alexander O. Vasilyev ◽  
Anton V. Sadchenko ◽  
...  

Background. Detection of prostate cancer by various targeting methods of prostate biopsy is an important problem now. Aim. To improve the detection of prostate cancer (PCa), compare the methods of targeted biopsy – cognitive biopsy guided by MRI with biopsy guided by histos-canning, using a randomized biopsy of the prostate from twelve cores as a control method. Materials and methods. A total of 145 respondents who underwent a randomized biopsy of the prostate in combination with targeted techniques were divided into 3 samples in accordance with the methods of targeted biopsy. In the results, the detectability by targeted methods was compared with each other and with a randomized biopsy as a control method. The results were subjected to statistical processing in order to form the conclusions of the study. Results. The detection rate of prostate cancer in the cognitive biopsy group was 64.4%, in the histofusion group – 51.1%, in the cognitive biopsy with histofusion group – 69% (p<0.05). The detection of PCa when comparing positive targeted biopsies did not differ statistically significantly between the methods (38 and 36%, p=0.05). The percentage of positive biopsies was higher with histofusion biopsy (34.2%) than with cognitive biopsy (29.7%), the incidence of clinically sig-nificant cancer was higher according to the results of targeted methods compared with randomized biopsy (73% vs 37.5%, p<0.05). The highest complication rate with the combined use of the studied targeting techniques was 13.6%, while all complications belonged to the 1st category according to Clavien–Dindo. Conclusion. To optimize the diagnosis of prostate cancer, it is advisable to use a combination of targeted and “randomized” cores. The combination of the targeted methods studied has been shown to be effective and safe. Carrying out a histofusion biopsy using a unified technique allows obtaining information on the clinical and morphological characteristics of prostate adenocarcinoma, which in terms of prognostic value is practically not inferior to the data of a cognitive biopsy performed taking into account the results of MRI. The use of targeted prostate biopsy methods increases the detection of clinically significant prostate cancer without adversely affecting the safety of the procedure in conjunction with standard prostate biopsy.


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