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18F-Choline PET/mpMRI for Detection of Clinically Significant Prostate Cancer: Part 1. Improved Risk Stratification for MRI-Guided Transrectal Prostate Biopsies.

ABSTRACT: A prospective single-arm clinical trial was conducted to determine whether 18F-choline PET/mpMRI can improve the specificity of multiparametric MRI (mpMRI) of the prostate for Gleason ? 3+4 prostate cancer. Methods: Before targeted and systematic prostate biopsy, mpMRI and 18F-choline PET/CT were performed on 56 evaluable subjects with 90 Likert score 3-5 mpMRI target lesions, using a 18F-choline target-to-background ratio of greater than 1.58 to indicate a positive 18F-choline result. Prostate biopsies were performed after registration of real-time transrectal ultrasound with T2-weighted MRI. A mixed-effects logistic regression was applied to measure the performance of mpMRI (based on prospective Likert and retrospective Prostate Imaging Reporting and Data System, version 2 [PI-RADS], scores) compared with 18F-choline PET/mpMRI to detect Gleason ? 3+4 cancer. Results: The per-lesion accuracy of systematic plus targeted biopsy for mpMRI alone was 67.8% (area under receiver-operating-characteristic curve [AUC], 0.73) for Likert 4-5 and 70.0% (AUC, 0.76) for PI-RADS 3-5. Several PET/MRI models incorporating 18F-choline with mpMRI data were investigated. The most promising model selected all high-risk disease on mpMRI (Likert 5 or PI-RADS 5) plus low- and intermediate-risk disease (Likert 4 or PI-RADS 3-4), with an elevated 18F-choline target-to-background ratio greater than 1.58 as positive for significant cancer. Using this approach, the accuracy on a per-lesion basis significantly improved to 88.9% for Likert (AUC, 0.90; P < 0.001) and 91.1% for PI-RADS (AUC, 0.92; P < 0.001). On a per-patient basis, the accuracy improved to 92.9% for Likert (AUC, 0.93; P < 0.001) and to 91.1% for PI-RADS (AUC, 0.91; P = 0.009). Conclusion: 18F-choline PET/mpMRI improved the identification of Gleason ? 3+4 prostate cancer compared with mpMRI, with the principal effect being improved risk stratification of intermediate-risk mpMRI lesions.

SUBMITTER: Davenport MS

PROVIDER: S-EPMC7067529 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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18F-Choline PET/mpMRI for Detection of Clinically Significant Prostate Cancer: Part 1. Improved Risk Stratification for MRI-Guided Transrectal Prostate Biopsies.

Davenport Matthew S MS Montgomery Jeffrey S JS Kunju Lakshmi Priya LP Siddiqui Javed J Shankar Prasad R PR Rajendiran Thekkelnaycke T Shao Xia X Lee Eunjee E Denton Brian B Barnett Christine C Piert Morand M

Journal of nuclear medicine : official publication, Society of Nuclear Medicine 20190816 3

A prospective single-arm clinical trial was conducted to determine whether 18F-choline PET/mpMRI can improve the specificity of multiparametric MRI (mpMRI) of the prostate for Gleason ≥ 3+4 prostate cancer. Methods: Before targeted and systematic prostate biopsy, mpMRI and 18F-choline PET/CT were performed on 56 evaluable subjects with 90 Likert score 3-5 mpMRI target lesions, using a 18F-choline target-to-background ratio of greater than 1.58 to indicate ...[more]

PMID: 31420496

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Project description:The objective of this study was to evaluate the cost-effectiveness of 18F-choline PET/multiparametric MRI (mpMRI) versus mpMRI alone for the detection of primary prostate cancer with a Gleason score of greater than or equal to 3 + 4 in men with elevated prostate-specific antigen levels. Methods: A Markov model of prostate cancer onset and progression was used to estimate the health and economic consequences of 18F-choline PET/mpMRI for the detection of primary prostate cancer with a Gleason score of greater than or equal to 3 + 4 in men with elevated prostate-specific antigen levels. Multiple simultaneous hybrid 18F-choline PET/mpMRI strategies were evaluated using Likert or Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) scoring; the first was biopsy for Likert 5 mpMRI lesions or Likert 3-4 lesions with 18F-choline target-to-background ratios of greater than or equal to 1.58, and the second was biopsy for PI-RADSv2 5 mpMRI lesions or PI-RADSv2 3-4 mpMRI lesions with 18F-choline target-to-background ratios of greater than or equal to 1.58. These strategies were compared with universal standard biopsy, mpMRI alone with biopsy only for PI-RADSv2 3-5 lesions, and mpMRI alone with biopsy only for Likert 4-5 lesions. For each mpMRI strategy, either no biopsy or standard biopsy could be performed after negative mpMRI results were obtained. Deaths averted, quality-adjusted life years (QALYs), cost, and incremental cost-effectiveness ratios were estimated for each strategy. Results: When the results of 18F-choline PET/mpMRI were negative, performing a standard biopsy was more expensive and had lower QALYs than performing no biopsy. The best screening strategy among those considered in this study performed hybrid 18F-choline PET/mpMRI with Likert scoring on men with elevated PSA, performed combined biopsy (targeted biopsy and standard 12-core biopsy) for men with positive imaging results, and no biopsy for men with negative imaging results ($22,706/QALY gained relative to mpMRI alone); this strategy reduced the number of biopsies by 35% in comparison to mpMRI alone. When the same policies were compared using PI-RADSv2 instead of Likert scoring, hybrid 18F-choline PET/mpMRI cost $46,867/QALY gained relative to mpMRI alone. In a threshold analysis, the best strategy among those considered remained cost-effective when the sensitivity and specificity of PET/mpMRI and combined biopsy (targeted biopsy and standard 12-core biopsy) were simultaneously reduced by 20 percentage points. Conclusion: 18F-choline PET/mpMRI for the detection of primary prostate cancer with a Gleason score of greater than or equal to 3 + 4 is cost-effective and can reduce the number of unneeded biopsies in comparison to mpMRI alone.

Project description:We assessed the value of fusion (18)F-fluoromethylcholine ((18)F-choline) PET/MRI for image-guided (targeted) prostate biopsies to detect significant prostate cancer (Gleason ? 3 + 4) compared with standard (systematic 12-core) biopsies.Within an ongoing prospective clinical trial, hybrid (18)F-choline PET/CT and multiparametric 3T MRI (mpMRI) of the pelvis were performed in 36 subjects with a rising prostate-specific antigen for known (n = 15) or suspected (n = 21) prostate cancer before a prostate biopsy procedure. PET and T2-weighted MR volumes of the prostate were spatially registered using commercially available software. Biopsy targets were selected on the basis of visual appearance on MRI and graded as low, intermediate, or high risk for significant disease. Volumes of interest were defined for MR-identified lesions. (18)F-choline uptake measures were obtained from the MR target and a mirrored background volume of interest. The biopsy procedure was performed after registration of real-time transrectal ultrasound with T2-weighted MR and included image-guided cores plus standard cores. Histologic results were determined from standard and targeted biopsy cores as well as prostatectomy specimens (n = 10).Fifteen subjects were ultimately identified with Gleason ? 3 + 4 prostate cancer, of which targeted biopsy identified significantly more (n = 12) than standard biopsies (n = 5; P = 0.002). A total of 52 lesions were identified by mpMRI (19 low, 18 intermediate, 15 high risk), and mpMRI-assigned risk was a strong predictor of final pathology (area under the curve = 0.81; P < 0.001). When the mean (18)F-choline target-to-background ratio was used, the addition of (18)F-choline to mpMRI significantly improved the prediction of Gleason ? 3 + 4 cancers over mpMRI alone (area under the curve = 0.92; P < 0.001).Fusion PET/MRI transrectal ultrasound image registration for targeted prostate biopsies is clinically feasible and accurate. The addition of (18)F-choline PET to mpMRI improves the identification of significant prostate cancer.

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.

Dataset Information

18F-Choline PET/mpMRI for Detection of Clinically Significant Prostate Cancer: Part 1. Improved Risk Stratification for MRI-Guided Transrectal Prostate Biopsies.

Publications

<sup>18</sup>F-Choline PET/mpMRI for Detection of Clinically Significant Prostate Cancer: Part 1. Improved Risk Stratification for MRI-Guided Transrectal Prostate Biopsies.

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