Multiparametric MRI to improve detection of prostate cancer compared with transrectal ultrasound-guided prostate biopsy alone: the PROMIS study
Louise BrownHashim U. AhmedRita FariaAhmed El‐Shater BosailyRhian GabeRichard KaplanMahesh ParmarYolanda Collaço‐MoraesKatie WardRichard G. HindleyAlex FreemanA. KirkhamRobert OldroydChris ParkerSimon BottNick Burns‐CoxTim DudderidgeManeesh GheiAlastair HendersonRaj PersadDerek J. RosarioIqbal ShergillMathias WinklerMarta SoaresEldon SpackmanMark SculpherMark Emberton
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Men with suspected prostate cancer usually undergo transrectal ultrasound (TRUS)-guided prostate biopsy. TRUS-guided biopsy can cause side effects and has relatively poor diagnostic accuracy. Multiparametric magnetic resonance imaging (mpMRI) used as a triage test might allow men to avoid unnecessary TRUS-guided biopsy and improve diagnostic accuracy.To (1) assess the ability of mpMRI to identify men who can safely avoid unnecessary biopsy, (2) assess the ability of the mpMRI-based pathway to improve the rate of detection of clinically significant (CS) cancer compared with TRUS-guided biopsy and (3) estimate the cost-effectiveness of a mpMRI-based diagnostic pathway.A validating paired-cohort study and an economic evaluation using a decision-analytic model.Eleven NHS hospitals in England.Men at risk of prostate cancer undergoing a first prostate biopsy.Participants underwent three tests: (1) mpMRI (the index test), (2) TRUS-guided biopsy (the current standard) and (3) template prostate mapping (TPM) biopsy (the reference test).Diagnostic accuracy of mpMRI, TRUS-guided biopsy and TPM-biopsy measured by sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) using primary and secondary definitions of CS cancer. The percentage of negative magnetic resonance imaging (MRI) scans was used to identify men who might be able to avoid biopsy.Diagnostic study - a total of 740 men were registered and 576 underwent all three tests. According to TPM-biopsy, the prevalence of any cancer was 71% [95% confidence interval (CI) 67% to 75%]. The prevalence of CS cancer according to the primary definition (a Gleason score of ≥ 4 + 3 and/or cancer core length of ≥ 6 mm) was 40% (95% CI 36% to 44%). For CS cancer, TRUS-guided biopsy showed a sensitivity of 48% (95% CI 42% to 55%), specificity of 96% (95% CI 94% to 98%), PPV of 90% (95% CI 83% to 94%) and NPV of 74% (95% CI 69% to 78%). The sensitivity of mpMRI was 93% (95% CI 88% to 96%), specificity was 41% (95% CI 36% to 46%), PPV was 51% (95% CI 46% to 56%) and NPV was 89% (95% CI 83% to 94%). A negative mpMRI scan was recorded for 158 men (27%). Of these, 17 were found to have CS cancer on TPM-biopsy. Economic evaluation - the most cost-effective strategy involved testing all men with mpMRI, followed by MRI-guided TRUS-guided biopsy in those patients with suspected CS cancer, followed by rebiopsy if CS cancer was not detected. This strategy is cost-effective at the TRUS-guided biopsy definition 2 (any Gleason pattern of ≥ 4 and/or cancer core length of ≥ 4 mm), mpMRI definition 2 (lesion volume of ≥ 0.2 ml and/or Gleason score of ≥ 3 + 4) and cut-off point 2 (likely to be benign) and detects 95% (95% CI 92% to 98%) of CS cancers. The main drivers of cost-effectiveness were the unit costs of tests, the improvement in sensitivity of MRI-guided TRUS-guided biopsy compared with blind TRUS-guided biopsy and the longer-term costs and outcomes of men with cancer.The PROstate Magnetic resonance Imaging Study (PROMIS) was carried out in a selected group and excluded men with a prostate volume of > 100 ml, who are less likely to have cancer. The limitations in the economic modelling arise from the limited evidence on the long-term outcomes of men with prostate cancer and on the sensitivity of MRI-targeted repeat biopsy.Incorporating mpMRI into the diagnostic pathway as an initial test prior to prostate biopsy may (1) reduce the proportion of men having unnecessary biopsies, (2) improve the detection of CS prostate cancer and (3) increase the cost-effectiveness of the prostate cancer diagnostic and therapeutic pathway. The PROMIS data set will be used for future research; this is likely to include modelling prognostic factors for CS cancer, optimising MRI scan sequencing and biomarker or translational research analyses using the blood and urine samples collected. Better-quality evidence on long-term outcomes in prostate cancer under the various management strategies is required to better assess cost-effectiveness. The value-of-information analysis should be developed further to assess new research to commission.Current Controlled Trials ISRCTN16082556 and NCT01292291.This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 39. See the NIHR Journals Library website for further project information. This project was also supported and partially funded by the NIHR Biomedical Research Centre at University College London (UCL) Hospitals NHS Foundation Trust and UCL and by The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research Biomedical Research Centre and was co-ordinated by the Medical Research Council's Clinical Trials Unit at UCL (grant code MC_UU_12023/28). It was sponsored by UCL. Funding for the additional collection of blood and urine samples for translational research was provided by Prostate Cancer UK.Keywords:
Multiparametric MRI
Prostate biopsy
The present study aimed to evaluate the indications for a second prostate biopsy in patients suspected with prostate cancer after an initial negative prostate biopsy. The present study included 421 patients who underwent repeat prostate biopsy between January 2007 and December 2015 at three hospitals. Clinicopathological data, including patient age, body mass index, history of prostate biopsy, prostate volume, prostate-specific antigen (PSA) level, PSA density, PSA velocity, and PSA fluctuation patterns, were analyzed. The patients were stratified into two groups based on the first PSA pattern (increase/decrease) within 1 year after the initial negative prostate biopsy. Prostate cancer was detected in 100 (23.8%) of the 421 patients at the second prostate biopsy. In patients with a PSA decrease at the first follow-up, prostate volume and number of increases in the PSA level from the initial prostate biopsy were predictors for prostate cancer diagnosis at the second prostate biopsy. In patients with a steady PSA increase after the initial prostate biopsy, prostate volume and number of biopsy cores were predictors for prostate cancer diagnosis at the second prostate biopsy. The indications for a second prostate biopsy are a low prostate volume and a high number of increases in the PSA level among patients with a PSA decrease at the first follow-up and a low prostate volume and a high number of biopsy cores among patients with a PSA increase at the first follow-up.
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To investigate the factors influencing the positive rate of prostate biopsy and its relationship with the prostate volume and inflammatory cell infiltration (ICI).We retrospectively analyzed the clinical data on 230 cases of double-plane transrectal ultrasound-guided prostate biopsy in our Department of Urology, including the patients' age, body mass index (BMI), serum total prostate-specific antigen (tPSA), PSA density (PSAD), prostate volume, and ICI in the prostate tissue. We also investigated the relationship of the above factors with the pathological results of prostate biopsy by binary logistic regression analysis.The positive rate of prostate biopsy was 38.7% (89/230) in the total number of cases, 28.57% (n = 56) in the 196 cases with tPSA < 100 μg/L, and 97.06% (n = 33) in the 34 cases with tPSA ≥ 100 μg/L. Binary logistic regression analysis showed that the positive rate of prostate biopsy in those with tPSA < 100 μg/L was correlated positively with age (P < 0.01, OR = 1.09), tPSA (P < 0.01, OR = 1.04) and PSAD (P < 0.01, OR = 10.04), negatively with the prostate volume (P < 0.01, OR = 0.98) and ICI (P < 0.01, OR = 0.22), but not with BMI (P > 0.05). As a predictor of positive prostate biopsy, tPSA > 10 μg/L exhibited a sensitivity of 82.14% and a specificity of 35.71%, while PSAD > 0.26 showed a sensitivity of 78.57% and a specificity of 71.43%.Non-specific elevation of the tPSA level induced by increased prostate volume and inflammatory cell infiltration may lead to unnecessary biopsies in some patients. As a predictor of positive prostate biopsy, PSAD > 0.26 has a higher clinical application value than tPSA > 10 μg/L.
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We analyzed the levels of selected micro-RNAs in normal prostate tissue to assess their potential to indicate tumor foci elsewhere in the prostate. Histologically normal prostate tissue samples from 31 prostate cancer patients and two cancer negative control groups with either unsuspicious or elevated prostate specific antigen (PSA) levels (14 and 17 individuals, respectively) were analyzed. Based on the expression analysis of 157 microRNAs in a pool of prostate tissue samples and information from data bases/literature, we selected eight microRNAs for quantification by real-time polymerase chain reactions (RT-PCRs). Selected miRNAs were analyzed in histologically tumor-free biopsy samples from patients and healthy controls. We identified seven microRNAs (miR-124a, miR-146a & b, miR-185, miR-16 and let-7a & b), which displayed significant differential expression in normal prostate tissue from men with prostate cancer compared to both cancer negative control groups. Four microRNAs (miR-185, miR-16 and let-7a and let-7b) remained to significantly discriminate normal tissues from prostate cancer patients from those of the cancer negative control group with elevated PSA levels. The transcript levels of these microRNAs were highly indicative for the presence of cancer in the prostates, independently of the PSA level. Our results suggest a microRNA-pattern in histologically normal prostate tissue, indicating prostate cancer elsewhere in the organ.
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MicroRNAs (miRNAs or miR-) have been linked to factors associated with aggressive prostate cancer such as biochemical recurrence and metastasis. We investigated whether circulating miRNAs in plasma could be used as diagnostic biomarkers for more aggressive prostate cancer at prostate biopsy.Men, aged 40 years and above, newly diagnosed with prostate cancer were categorized into two risk groups, low-grade (Gleason score, 6 or 7 [3 + 4] and serum prostate-specific antigen [PSA], <20 ng/mL) and high-grade (Gleason score, ≥7 (4 + 3) and serum PSA, ≥20 ng/mL) prostate cancers. The limma R package was used to compare the expression of miRNAs in plasma between the two risk groups, adjusting for age.There were 66 men, aged 46-86 years, included: 40 men with low-grade and 26 men with high-grade prostate cancers. There were lower expressions of miR-28, miR-100, miR-942, and miR-28-3p, and higher expressions of miR-708, miR-1298, miR-886-3p, miR-374, miR-376c, miR-202, miR-128a, and miR-185 in high-grade compared to low-grade prostate cancer cases at biopsy, after adjusting for age (P < 0.05). These differences were no longer statistically significant after adjusting the P values for multiple comparisons.There was no circulating miRNA associated with high-grade prostate cancer at biopsy after adjusting for age and multiple comparisons. Nevertheless, relationships between these circulating miRNAs and high-grade prostate cancer were observed, which suggest them as promising prostate cancer biomarkers. Further investigation in a larger cohort may provide insight into their diagnostic potential for aggressive prostate cancer.
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To evaluate the spatial distribution of prostate cancer detected at a single positive biopsy (PBx) and a repeat PBx (rPBx).We evaluated 533 consecutive men diagnosed with prostate cancer who underwent radical prostatectomy using a clinical map document based on XML (cMDX©)-based map model of the prostate. We determined the number of cancer foci, relative tumour volume, Gleason score, zone of origin, localisation, and pathological stage after stratification according to the number of PBx sessions (PBx vs rPBx). The distribution of 3966 prostate cancer foci was analysed and visualised on heat maps. The colour gradient of the heat map was reduced to six colours representing the frequency classification of prostate cancer using an image posterisation effect. Additionally, the spatial distribution of organ-confined prostate cancer between PBx and rPBx was evaluated.Prostate cancer diagnosed on PBx was mostly localised to the apical portion and the peripheral zone of the prostate. Prostate cancer diagnosed on rPBx was more frequently found in the anterior portion and the base of the prostate. Organ-confined prostate cancer foci were mostly localised in the dorsolateral zone of the prostate in men at PBx, whereas men at rPBx had more prostate cancer foci in the anterior portion.The spatial distribution of prostate cancer with rPBx differs significantly from the spatial distribution of prostate cancer with PBx. The whole anterior portion of the prostate should be considered by rPBx.
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Objective To evaluate the feasibility of prostate biopsy under direct vision.Methods 56 patients recieved transrectal prostate biopsy under direct vision with a modified prone position.We used dilator and anal mirror suture device(parts of the PPH kit)to help revealing the prostate. Results Transrectal prostate biopsy under direct vision could achieve a very good view of prostate and made puncture easier by controlling the depth and direction.The puncture located well. The patient′s position was comfortable.The procedure were well tolerated in all patients.No serious complications occurred. Conclusions Transrectal prostate biopsy under direct vision with a modified prone position is simple and accurate.It might be generalized in the future.
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Objective To investigate the expressions of mitosis regulative factor STK-15 in prostate cancer and the relationship between STK-15 and the biological behavior of prostate cancer.Methods The expressions of STK-15 were examined by using immunohistochemical staining on 63 cases of prostate cancer and 16 cases of normal prostate tissues.And the expressions of STK-15 mRNA were detected by using RT-PCR in 14 cases of prostate cancer,BPH,and normal prostate tissues respectively.Results The STK15 protein was expressed in 98%(62/63) of prostate cancer tissue and in 19%(3/16) of normal prostate tissues.The difference between these expression rates was significant(P0.001).Meanwhile,the positive expression rates of STK-15 mRNA in prostate cancer,BPH,and normal prostate tissue were 93%(13/14),21%(3/14) and 14%(2/14) respectively.Compared with those in BPH and normal prostate tissue,the STK-15 mRNA expression rate in prostate cancer was significantly high(P0.001).Meanwhile,there was no significant difference between those in BPH and normal prostate tissue(P0.05).Conclusion The expressions of STK-15 increase in prostate cancer tissues which may contribute to the prostate carcinogenesis.
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Purpose: Several studies have reported computerized tomography (CT) overestimates prostate volume by 30 to 50% in comparison to ultrasound in prostate radiation therapy. To further elucidate this phenomenon, we compared the differences in prostate volume assessed by ultrasound and CT, specifically with in vivo and ex vivo ultrasound, and ex vivo CT. Method and Materials: Seven patients with localized prostate cancer treated with radical prostatectomy were enrolled. Each patient was scanned with transrectal ultrasound (TRUS) prior to surgery. Prostate specimens were immediately scanned post-surgery with both ultrasound and CT. 3-D imaging scans were acquired from the base to the apex of the prostate in the axial plane in 2 mm and 1.25 mm slices for ultrasound and CT imaging, respectively. The prostate gland was contoured on each 3-D ultrasound and CT image set by one radiation oncologist and then volume calculations were made based on voxel size. Results: The in vivo prostate volume acquired with ultrasound was on average 33.2 cc (range 25.7 – 41.3 cc). The ex vivo CT and ultrasound volumes of the prostate specimens were 32.8 cc (range 24.7 – 41.1) and 32.7 cc (range 24.9 – 40.3), respectively. The ex vivo and ex vivo ultrasound prostate volume measurements were within 5% of each other. Overall, there was a 1 to 2% reduction between the imaged pre and post-surgery prostate volumes. For each individual specimen the concordance between the CT and ultrasound volumes was within 5%. Conclusion: While several studies have consistently reported larger prostate volumes when using CT as compared to transrectal ultrasound, our study shows no intrinsic difference between ultrasound and CT imaging in terms of prostate volume measurements. Therefore, we propose the difficulty with precise prostate contour delineation encountered with CT imaging results in the frequent overestimation of the prostate gland size seen in prostate radiation therapy.
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Abstract Background We assessed the effect of biopsy location on the prostate cancer detection and clinically significant prostate cancer. Methods A total of 2774 patients with 12‐core prostate transrectal ultrasound‐guided prostate biopsy were included for per core analysis. Multivariate Cox regression analysis was performed to evaluate the effect of the location of biopsy on the prostate cancer and clinically significant prostate cancer detection. Results Prostate cancer was found in 775 patients (27.9%) and 576 prostate cancer patients (20.8%) were found to be clinically significant. The core length ( P = .043), tumor length ( P < .001), and % tumor length ( P < .001) were significantly different according to the biopsy location. The detection rates for prostate cancer and clinically significant prostate cancer differed significantly according to the location of biopsy. Multivariate analysis revealed that the apical core was significantly related with increased detection of prostate cancer and clinically significant prostate cancer. The lateral core, in addition to apical core, was found to be significantly related with increased detection rates of prostate cancer and clinically significant prostate cancer in men with prostate‐specific antigen <10 ng/mL. Conclusions More in‐depth discussions on the location of standard 12‐core prostate biopsy are considered necessary. Apical core and lateral core biopsies may be helpful, especially in patients with prostate‐specific antigen ˂10 ng/mL if additional biopsies are planned following findings of no target lesions on imaging studies.
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