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Identification of threshold prostate specific antigen levels to optimize the detection of clinically significant prostate cancer by magnetic resonance imaging/ultrasound fusion guided biopsy.

ABSTRACT: PURPOSE:Prostate specific antigen sensitivity increases with lower threshold values but with a corresponding decrease in specificity. Magnetic resonance imaging/ultrasound targeted biopsy detects prostate cancer more efficiently and of higher grade than standard 12-core transrectal ultrasound biopsy but the optimal population for its use is not well defined. We evaluated the performance of magnetic resonance imaging/ultrasound targeted biopsy vs 12-core biopsy across a prostate specific antigen continuum. MATERIALS AND METHODS:We reviewed the records of all patients enrolled in a prospective trial who underwent 12-core transrectal ultrasound and magnetic resonance imaging/ultrasound targeted biopsies from August 2007 through February 2014. Patients were stratified by each of 4 prostate specific antigen cutoffs. The greatest Gleason score using either biopsy method was compared in and across groups as well as across the population prostate specific antigen range. Clinically significant prostate cancer was defined as Gleason 7 (4 + 3) or greater. Univariate and multivariate analyses were performed. RESULTS:A total of 1,003 targeted and 12-core transrectal ultrasound biopsies were performed, of which 564 diagnosed prostate cancer for a 56.2% detection rate. Targeted biopsy led to significantly more upgrading to clinically significant disease compared to 12-core biopsy. This trend increased more with increasing prostate specific antigen, specifically in patients with prostate specific antigen 4 to 10 and greater than 10 ng/ml. Prostate specific antigen 5.2 ng/ml or greater captured 90% of upgrading by targeted biopsy, corresponding to 64% of patients who underwent multiparametric magnetic resonance imaging and subsequent fusion biopsy. Conversely a greater proportion of clinically insignificant disease was detected by 12-core vs targeted biopsy overall. These differences persisted when controlling for potential confounders on multivariate analysis. CONCLUSIONS:Prostate cancer upgrading with targeted biopsy increases with an increasing prostate specific antigen cutoff. Above a prostate specific antigen threshold of 5.2 ng/ml most upgrading to clinically significant disease was achieved by targeted biopsy. In our population this corresponded to potentially sparing biopsy in 36% of patients who underwent multiparametric magnetic resonance imaging. Below this value 12-core biopsy detected more clinically insignificant cancer. Thus, the diagnostic usefulness of targeted biopsy is optimized in patients with prostate specific antigen 5.2 ng/ml or greater.

SUBMITTER: Shakir NA

PROVIDER: S-EPMC4684948 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature

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Identification of threshold prostate specific antigen levels to optimize the detection of clinically significant prostate cancer by magnetic resonance imaging/ultrasound fusion guided biopsy.

Shakir Nabeel A NA George Arvin K AK Siddiqui M Minhaj MM Rothwax Jason T JT Rais-Bahrami Soroush S Stamatakis Lambros L Su Daniel D Okoro Chinonyerem C Raskolnikov Dima D Walton-Diaz Annerleim A Simon Richard R Turkbey Baris B Choyke Peter L PL Merino Maria J MJ Wood Bradford J BJ Pinto Peter A PA

The Journal of urology 20140809 6

<h4>Purpose</h4>Prostate specific antigen sensitivity increases with lower threshold values but with a corresponding decrease in specificity. Magnetic resonance imaging/ultrasound targeted biopsy detects prostate cancer more efficiently and of higher grade than standard 12-core transrectal ultrasound biopsy but the optimal population for its use is not well defined. We evaluated the performance of magnetic resonance imaging/ultrasound targeted biopsy vs 12-core biopsy across a prostate specific ...[more]

PMID: 25117476

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Project description:PurposeGiven the limitations of prostate specific antigen and standard biopsies for detecting prostate cancer, we evaluated the cancer detection rate and external validity of a magnetic resonance imaging/transrectal ultrasound fusion guided prostate biopsy system used at the National Institutes of Health.Materials and methodsWe performed a phase III trial of a magnetic resonance imaging/transrectal ultrasound fusion guided prostate biopsy system with participants enrolled between 2012 and 2013. A total of 153 men consented to the study and underwent 3 Tesla multiparametric magnetic resonance imaging with an endorectal coil for clinical suspicion of prostate cancer. Lesions were classified as low or moderate/high risk for prostate cancer. Magnetic resonance imaging/transrectal ultrasound fusion guided biopsy and standard 12-core prostate biopsy were performed and 105 men were eligible for analysis.ResultsMean patient age was 65.8 years and mean prostate specific antigen was 9.5 ng/ml. The overall cancer detection rate was 62.9% (66 of 105 patients). The cancer detection rate in those with moderate/high risk on imaging was 72.3% (47 of 65) vs 47.5% (19 of 40) in those classified as low risk for prostate cancer (p<0.05). Mean tumor core length was 4.6 and 3.7 mm for fusion biopsy and standard 12-core biopsy, respectively (p<0.05). Magnetic resonance imaging/transrectal ultrasound fusion guided biopsy detected prostate cancer that was missed by standard 12-core biopsy in 14.3% of cases (15 of 105), of which 86.7% (13 of 15) were clinically significant. This biopsy upgraded 23.5% of cancers (4 of 17) deemed clinically insignificant on 12-core biopsy to clinically significant prostate cancer necessitating treatment.ConclusionsMagnetic resonance imaging/transrectal ultrasound fusion guided biopsy can improve prostate cancer detection. The results of this trial support the external validity of this platform and may be the next step in the evolution of prostate cancer management.

Project description:ImportanceTargeted magnetic resonance (MR)/ultrasound fusion prostate biopsy has been shown to detect prostate cancer. The implications of targeted biopsy alone vs standard extended-sextant biopsy or the 2 modalities combined are not well understood.ObjectiveTo assess targeted vs standard biopsy and the 2 approaches combined for the diagnosis of intermediate- to high-risk prostate cancer.Design, setting, and participantsProspective cohort study of 1003 men undergoing both targeted and standard biopsy concurrently from 2007 through 2014 at the National Cancer Institute in the United States. Patients were referred for elevated level of prostate-specific antigen (PSA) or abnormal digital rectal examination results, often with prior negative biopsy results. Risk categorization was compared among targeted and standard biopsy and, when available, whole-gland pathology after prostatectomy as the "gold standard."InterventionsPatients underwent multiparametric prostate magnetic resonance imaging to identify regions of prostate cancer suspicion followed by targeted MR/ultrasound fusion biopsy and concurrent standard biopsy.Main outcomes and measuresThe primary objective was to compare targeted and standard biopsy approaches for detection of high-risk prostate cancer (Gleason score ≥ 4 + 3); secondary end points focused on detection of low-risk prostate cancer (Gleason score 3 + 3 or low-volume 3 + 4) and the biopsy ability to predict whole-gland pathology at prostatectomy.ResultsTargeted MR/ultrasound fusion biopsy diagnosed 461 prostate cancer cases, and standard biopsy diagnosed 469 cases. There was exact agreement between targeted and standard biopsy in 690 men (69%) undergoing biopsy. Targeted biopsy diagnosed 30% more high-risk cancers vs standard biopsy (173 vs 122 cases, P < .001) and 17% fewer low-risk cancers (213 vs 258 cases, P < .001). When standard biopsy cores were combined with the targeted approach, an additional 103 cases (22%) of mostly low-risk prostate cancer were diagnosed (83% low risk, 12% intermediate risk, and 5% high risk). The predictive ability of targeted biopsy for differentiating low-risk from intermediate- and high-risk disease in 170 men with whole-gland pathology after prostatectomy was greater than that of standard biopsy or the 2 approaches combined (area under the curve, 0.73, 0.59, and 0.67, respectively; P < .05 for all comparisons).Conclusions and relevanceAmong men undergoing biopsy for suspected prostate cancer, targeted MR/ultrasound fusion biopsy, compared with standard extended-sextant ultrasound-guided biopsy, was associated with increased detection of high-risk prostate cancer and decreased detection of low-risk prostate cancer. Future studies will be needed to assess the ultimate clinical implications of targeted biopsy.Trial registrationclinicaltrials.gov Identifier: NCT00102544.

Project description:The purpose of this study was to investigate the feasibility and diagnostic efficacy of 68Ga-prostate-specific membrane antigen (PSMA) PET/CT combined with PET/ultrasound-guided biopsy in the diagnosis of prostate cancer (PCa). Methods: In total, 31 patients with a previously negative prostate biopsy but persistent elevated serum prostate-specific antigen (PSA) were imaged with a 68Ga-PSMA PET/CT ligand before undergoing repeat prostate biopsy. On the basis of the proposed Prostate Cancer Molecular Imaging Standardized Evaluation criteria, 68Ga-PSMA PET/CT results were interpreted as negative (molecular-imaging-for-PSMA expression score [miPSMA-ES] of 0-1) or positive (miPSMA-ES of 2-3). All patients underwent standard template systematic biopsy with up to 4 additional PET/ultrasound-guided biopsy cores. The sensitivity, specificity, positive and negative predictive values, and accuracy of 68Ga-PSMA PET/CT were determined. In addition, the correlation between the miPSMA-ES and the detection rate of PCa was also analyzed. Univariate logistic regression models were established using 68Ga-PSMA PET/CT semiquantitative analysis parameters to predict the outcome of repeat prostate biopsy. Results: The median age of patients was 65 y (range, 53-81 y), and the median PSA level was 18.0 ng/mL (range, 5.48-49.77 ng/mL). PCa was detected in 15 of 31 patients (48.4%), and 12 of 31 patients (38.7%) had clinically significant PCa (csPCa). The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 68Ga-PSMA PET/CT in the diagnosis of csPCa were 100.0%, 68.4%, 66.7%, 100.0%, and 80.6%, respectively. The detection rate of PCa increased with the increase in miPSMA-ES. The detection rates of csPCa in the miPSMA-ES 0-1, 2, and 3 groups were 0%, 54.5%, and 85.7%, respectively. Semiquantitative analysis of 68Ga-PSMA PET/CT images showed that predictive models based on the SUVmax of prostate lesion, tumor-to-normal-prostate background SUVmax, and tumor-to-normal-liver background SUVmax could effectively predict csPCa; area under the curves were 0.930, 0.877, and 0.956, respectively. Conclusion: This study preliminarily confirmed that 68Ga-PSMA PET/CT imaging, combined with PET/ultrasound-guided prostate biopsy, can effectively detect csPCa. Prebiopsy 68Ga-PSMA PET/CT had predictive value for csPCa in the studied patient population.

Dataset Information

Identification of threshold prostate specific antigen levels to optimize the detection of clinically significant prostate cancer by magnetic resonance imaging/ultrasound fusion guided biopsy.

Publications

Identification of threshold prostate specific antigen levels to optimize the detection of clinically significant prostate cancer by magnetic resonance imaging/ultrasound fusion guided biopsy.

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