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The comparative effectiveness of mpMRI and MRI-guided biopsy vs regular biopsy in a population-based PSA testing: a modeling study.

ABSTRACT: The benefit of prostate cancer screening is counterbalanced by the risk of overdiagnosis and overtreatment. The use of a multi-parametric magnetic resonance imaging (mpMRI) test after a positive prostate-specific antigen (PSA) test followed by magnetic resonance imaging-guided biopsy (MRIGB) may reduce these harms. The aim of this study was to determine the effects of mpMRI and MRIGB vs the regular screening pathway in a population-based prostate cancer screening setting. A micro-simulation model was used to predict the effects of regular PSA screening (men with elevated PSA followed by TRUSGB) and MRI based screening (men with elevated PSA followed by mpMRI and MRIGB). We predicted reduction of overdiagnosis, harm-benefit ratio (overdiagnosis per cancer death averted), reduction in number of biopsies, detection of clinically significant cancer, prostate cancer death averted, life-years gained (LYG), and quality adjusted life years (QALYs) gained for both strategies. A univariate sensitivity analysis and threshold analysis were performed to assess uncertainty around the test sensitivity parameters used in the MRI strategy.In the MRI pathway, we predicted a 43% reduction in the risk of overdiagnosis, compared to the regular pathway. Similarly a lower harm-benefit ratio (overdiagnosis per cancer death averted) was predicted for this strategy compared to the regular screening pathway (1.0 vs 1.8 respectively). Prostate cancer mortality reduction, LY and QALYs gained were also slightly increased in the MRI pathway than the regular screening pathway. Furthermore, 30% of men with a positive PSA test could avoid a biopsy as compared to the regular screening pathway. Compared to regular PSA screening, the use of mpMRI as a triage test followed by MRIGB can substantially reduce the risk of overdiagnosis and improve the harm-benefit balance, while maximizing prostate cancer mortality reduction and QALYs gained.

SUBMITTER: Getaneh AM

PROVIDER: S-EPMC7815791 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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The comparative effectiveness of mpMRI and MRI-guided biopsy vs regular biopsy in a population-based PSA testing: a modeling study.

Getaneh Abraham M AM Heijnsdijk Eveline A M EAM de Koning Harry J HJ

Scientific reports 20210119 1

The benefit of prostate cancer screening is counterbalanced by the risk of overdiagnosis and overtreatment. The use of a multi-parametric magnetic resonance imaging (mpMRI) test after a positive prostate-specific antigen (PSA) test followed by magnetic resonance imaging-guided biopsy (MRIGB) may reduce these harms. The aim of this study was to determine the effects of mpMRI and MRIGB vs the regular screening pathway in a population-based prostate cancer screening setting. A micro-simulation mode ...[more]

PMID: 33469144

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Project description:ImportanceMagnetic resonance imaging (MRI) and potential MRI-guided biopsy enable enhanced identification of clinically significant prostate cancer. Despite proven efficacy, MRI and potential MRI-guided biopsy remain costly, and there is limited evidence regarding the cost-effectiveness of this approach in general and for different prostate-specific antigen (PSA) strata.ObjectiveTo examine the cost-effectiveness of integrating annual MRI and potential MRI-guided biopsy as part of clinical decision-making for men after being screened for prostate cancer compared with standard biopsy.Design, setting, and participantsUsing a decision analytic Markov cohort model, an economic evaluation was conducted projecting outcomes over 10 years for a hypothetical cohort of 65-year-old men in the US with 4 different PSA strata (<2.5 ng/mL, 2.5-4.0 ng/mL, 4.1-10.0 ng/mL, >10 ng/mL) identified by screening through Monte Carlo microsimulation with 10 000 trials. Model inputs for probabilities, costs in 2020 US dollars, and quality-adjusted life-years (QALYs) were from the literature and expert consultation. The model was specifically designed to reflect the US health care system, adopting a federal payer perspective (ie, Medicare).ExposuresMagnetic resonance imaging with potential MRI-guided biopsy and standard biopsy.Main outcomes and measuresIncremental cost-effectiveness ratios (ICERs) using a willingness-to-pay threshold of $100 000 per QALY was estimated. One-way and probabilistic sensitivity analyses were performed.ResultsFor the 3 PSA strata of 2.5 ng/mL or greater, the MRI and potential MRI-guided biopsy strategy was cost-effective compared with standard biopsy (PSA 2.5-4.0 ng/mL: base-case ICER, $21 131/QALY; PSA 4.1-10.0 ng/mL: base-case ICER, $12 336/QALY; PSA >10.0 ng/mL: base-case ICER, $6000/QALY). Results varied depending on the diagnostic accuracy of MRI and potential MRI-guided biopsy. Results of probabilistic sensitivity analyses showed that the MRI and potential MRI-guided biopsy strategy was cost-effective at the willingness-to-pay threshold of $100 000 per QALY in a range between 76% and 81% of simulations for each of the 3 PSA strata of 2.5 ng/mL or more.Conclusions and relevanceThis economic evaluation of a hypothetical cohort suggests that an annual MRI and potential MRI-guided biopsy was a cost-effective option from a US federal payer perspective compared with standard biopsy for newly eligible male Medicare beneficiaries with a serum PSA level of 2.5 ng/mL or more.

Project description:ObjectiveTo compare Prostate Health Index (PHI) and prostate-specific antigen (PSA) density as secondary tests after multiparametric magnetic resonance imaging (mpMRI) in improving the detection accuracy of Gleason grade group (GG) 2-5 prostate cancer (PCa) and in decreasing unnecessary biopsies in a multiethnic biopsy-naïve population.MethodsFrom February 2017 to February 2020, we recruited consecutive biopsy-naïve men in participating urology clinics for elevated PSA levels. They all had a PHI score, mpMRI, and prostate biopsy. Experienced genitourinary radiologists read all mpMRI studies based on PIRADS version 2.0. Logistic regression models were used to generate receiver operating characteristic curves. Models were tested for effect modification between Race (Black vs White) and both PHI and PSA density, and Race and PIRADS to determine if race impacted their prediction accuracy. Sensitivity, specificity, and predictive values of PHI and PSA density thresholds were calculated by PIRADS scores. The primary outcome was GG2-5 PCa, that is, Gleason score ≥3 + 4.ResultsThe study included 143 men, of which 65 (45.5%) were self-reported Black. Median age was 62.0 years and 55 men (38.4%) had GG2-5 PCa. Overall, 18.1% had PIRADS 1-2, 32.9% had PIRADS 3, and 49.0% had PIRADS 4-5. For the binary logistic regressions, the interactions between PIRADS and Race (P = .08), Log (PHI) and Race (P = .17), and Log (PSA density) and Race (P = .42) were not statistically significant. Within PIRADS 3 lesions, a PHI ≥49 prevented unnecessary biopsies in 55% of men and missed no GG2-5 PCa, yielding a negative predictive value of 100%. There was no reliable PHI or PSA density threshold to avoid PCa biopsies in PIRADS 1-2 or 4-5.ConclusionsPHI and PSA density can be used after mpMRI to improve the detection of GG2-5 PCa in a biopsy-naïve cohort. PHI may be superior to PSA density in PIRADS 3 lesions by avoiding 55% of unnecessary biopsies. Using both PHI and PSA density in series may further increase specificity and lead to fewer unnecessary biopsies, but further larger studies are warranted to determine the optimal threshold of each biomarker.

Project description:IntroductionModern image-guided biopsy pathways at diagnostic centres have greatly refined the investigations of men referred with suspected prostate cancer. However, the referral criteria from primary care are still based on historical prostate-specific antigen (PSA) cut-offs and age-referenced thresholds. Here, we tested whether better contemporary pathways and biopsy methods had improved the predictive utility value of PSA referral thresholds.MethodsPSA referral thresholds, age-referenced ranges and PSA density (PSAd) were assessed for positive predictive value (PPV) in detection of clinically significant prostate cancer (csPCa - histological ⩾ Grade Group 2). Data were analysed from men referred to three diagnostics centres who used multi-parametric magnetic resonance imaging (mpMRI)-guided prostate biopsies for disease characterisation. Findings were validated in a separate multicentre cohort. Results: Data from 2767 men were included in this study. The median age, PSA and PSAd were 66.4 years, 7.3 ng/mL and 0.1 ng/mL2, respectively. Biopsy detected csPCa was found in 38.7%. The overall area under the curve (AUC) for PSA was 0.68 which is similar to historical performance. A PSA threshold of ⩾ 3 ng/mL had a PPV of 40.3%, but this was age dependent (PPV: 24.8%, 32.7% and 56.8% in men 50-59 years, 60-69 years and ⩾ 70 years, respectively). Different PSA cut-offs and age-reference ranges failed to demonstrate better performance. PSAd demonstrated improved AUC (0.78 vs 0.68, p < 0.0001) and improved PPV compared to PSA. A PSAd of ⩾ 0.10 had a PPV of 48.2% and similar negative predictive value (NPV) to PSA ⩾ 3 ng/mL and out-performed PSA age-reference ranges. This improved performance was recapitulated in a separate multi-centre cohort (n = 541).ConclusionThe introduction of MRI-based image-guided biopsy pathways does not appear to have altered PSA diagnostic test characteristics to positively detect csPCa. We find no added value to PSA age-referenced ranges, while PSAd offers better PPV and the potential for a single clinically useful threshold (⩾0.10) for all age groups.Level of evidenceIV.

Project description:PURPOSE:On-board magnetic resonance imaging (MRI) greatly enhances real-time target tracking capability during radiotherapy treatments. However, multislice and volumetric MRI techniques are frame rate limited and introduce unacceptable latency between the target moving out of position and the beam being turned off. We present a technique to estimate continuous volumetric tissue motion using motion models built from a repeated acquisition of a stack of MR slices. Applications including multislice target visualization and out-of-slice motion estimation during MRI-guided radiotherapy are demonstrated. METHODS:Eight healthy volunteer studies were performed using a 0.35 T MRI-guided radiotherapy system. Images were acquired at three frames per second in an interleaved fashion across ten adjacent sagittal slice positions covering 4.5 cm using a balanced steady-state-free precession sequence. A previously published five-dimensional (5D) linear motion model used for MRI-guided radiotherapy gating was extended to include multiple slices. This model utilizes an external respiratory bellows signal recorded during imaging to simultaneously estimate motion across all imaged slices. For comparison to an image-based approach, the manifold learning technique local linear embedding (LLE) was used to derive a respiratory surrogate for motion modeling. Manifolds for every slice were aligned during LLE in a group-wise fashion, enabling motion estimation outside the current imaged slice using a motion model, a process which we denote as mSGA. Additionally, a method is developed to evaluate out-of-slice motion estimates. The multislice motion model was evaluated in a single slice with each newly acquired image using a leave-one-out approach. Model-generated gating decision accuracy and beam-on positive predictive value (PPV) are reported along with the median and 95th percentile distance between model and ground truth target centroids. RESULTS:The average model gating decision accuracy and PPV across all volunteer studies was 93.7% and 92.8% using the 5D model, and 96.8% and 96.1% using the mSGA model, respectively. The median and 95th percentile distance between model and ground truth target centroids was 0.91 and 2.90 mm, respectively, using the 5D model and 0.58 and 1.49 mm using the mSGA model, averaged over all eight subjects. The mSGA motion model provided a statistically significant improvement across all evaluation metrics compared to the external surrogate-based 5D model. CONCLUSION:The proposed techniques for out-of-slice target motion estimation demonstrated accuracy likely sufficient for clinical use. Results indicate the mSGA model may provide higher accuracy, however, the external surrogate-based model allows for unbiased in vivo accuracy evaluation.

Dataset Information

The comparative effectiveness of mpMRI and MRI-guided biopsy vs regular biopsy in a population-based PSA testing: a modeling study.

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The comparative effectiveness of mpMRI and MRI-guided biopsy vs regular biopsy in a population-based PSA testing: a modeling study.

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