Progression and treatment rates using an active surveillance protocol incorporating image‐guided baseline biopsies and multiparametric magnetic resonance imaging monitoring for men with favourable‐risk prostate cancer

Thurtle, David; Barrett, Tristan; Thankappannair, Vineetha; Koo, Brendan; Warren, Anne Y.; Kastner, Christof; Saeb‐Parsy, Kasra; Kimberley-Duffell, Jenna; Gnanapragasam, Vincent

doi:10.1111/bju.14166

Cited by 50 publications

(51 citation statements)

References 33 publications

(39 reference statements)

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“…Moreover, the use of MRI as a tool to risk stratify men with low-risk PCa has been emerging over time. A study by Thurtle et al [26] evaluated data from 157 men enrolled on AS using a protocol including multiparametric MRI, and noted low progression and treatment conversion rates. Changes in multiparametric MRI findings were found to be the principal trigger for detecting progression by imaging alone or pathologically.…”

Section: Discussionmentioning

confidence: 99%

Reasons for Discontinuing Active Surveillance: Assessment of 21 Centres in 12 Countries in the Movember GAP3 Consortium

Lee

Kattan

et al. 2019

European Urology

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Background: Careful assessment of the reasons for discontinuation of active surveillance (AS) is required for men with prostate cancer (PCa). Objective: Using Movember's Global Action Plan Prostate Cancer Active Surveillance initiative (GAP3) database, we report on reasons for AS discontinuation. Design, setting, and participants: We compared data from 10 296 men on AS from 21 centres across 12 countries. Outcome measurements and statistical analysis: Cumulative incidence methods were used to estimate the cumulative incidence rates of AS discontinuation. Results and limitations: During 5-yr follow-up, 27.5% (95% confidence interval [CI]: 26.4-28.6%) men showed signs of disease progression, 12.8% (95% CI: 12.0-13.6%) converted to active treatment without evidence of progression, 1.7% (95% CI: 1.5-2.0%) continued to watchful waiting, and 1.7% (95% CI: 1.4-2.1%) died from other causes. Of the 7049 men who remained on AS, 2339 had follow-up for >5 yr, 4561 had follow-up for <5 yr, and 149 were lost to follow-up. Cumulative incidence of progression was 27.5% (95% CI: 26.4-28.6%) at 5 yr and 38.2% (95% CI: 36.7-39.9%) at 10 yr. A limitation is that not all centres were included due to limited information on the reason for discontinuation and limited follow-up. Conclusions: Our descriptive analyses of current AS practices worldwide showed that 43.6% of men drop out of AS during 5-yr follow-up, mainly due to signs of disease progression. Improvements in selection tools for AS are thus needed to correctly allocate men with PCa to AS, which will also reduce discontinuation due to conversion to active treatment without evidence of disease progression. Patient summary: Our assessment of a worldwide database of men with prostate cancer (PCa) on active surveillance (AS) shows that 43.6% drop out of AS within 5 yr, mainly due to signs of disease progression. Better tools are needed to select and monitor men with PCa as part of AS.

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Section: Discussionmentioning

confidence: 99%

Reasons for Discontinuing Active Surveillance: Assessment of 21 Centres in 12 Countries in the Movember GAP3 Consortium

Lee

Kattan

et al. 2019

European Urology

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“…Briefly, included in this study were men aged <80 years with clinical stage T1-T2, PSA level ≤20 ng/ mL, histological GG ≤2, a composite CPG criterion of 1 or 2 at entry, data on MRI prostate volume and derived PSA density (PSAD), and ≥12 months of follow-up. All men had similar planned follow-up with 3-monthly PSA testing, annual repeat mpMRI, and scheduled protocol interval re-biopsies, as previously reported [13]. To re-test the finding, we sourced an independent cohort from Spain (Valencia).…”

Section: Predicting Progression and Stratifying Follow-up On Asmentioning

confidence: 97%

Using prognosis to guide inclusion criteria, define standardised endpoints and stratify follow‐up in active surveillance for prostate cancer

et al. 2019

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Objectives To test whether using disease prognosis can inform a rational approach to active surveillance (AS) for early prostate cancer. Patients and methods We previously developed the Cambridge Prognostics Groups (CPG) classification, a five‐tiered model that uses prostate‐specific antigen (PSA), Grade Group and Stage to predict cancer survival outcomes. We applied the CPG model to a UK and a Swedish prostate cancer cohort to test differences in prostate cancer mortality (PCM) in men managed conservatively or by upfront treatment in CPG2 and 3 (which subdivides the intermediate‐risk classification) vs CPG1 (low‐risk). We then applied the CPG model to a contemporary UK AS cohort, which was optimally characterised at baseline for disease burden, to identify predictors of true prognostic progression. Results were re‐tested in an external AS cohort from Spain. Results In a UK cohort (n = 3659) the 10‐year PCM was 2.3% in CPG1, 1.5%/3.5% in treated/untreated CPG2, and 1.9%/8.6% in treated/untreated CPG3. In the Swedish cohort (n = 27 942) the10‐year PCM was 1.0% in CPG1, 2.2%/2.7% in treated/untreated CPG2, and 6.1%/12.5% in treated/untreated CPG3. We then tested using progression to CPG3 as a hard endpoint in a modern AS cohort (n = 133). During follow‐up (median 3.5 years) only 6% (eight of 133) progressed to CPG3. Predictors of progression were a PSA density ≥0.15 ng/mL/mL and CPG2 at diagnosis. Progression occurred in 1%, 8% and 21% of men with neither factor, only one, or both, respectively. In an independent Spanish AS cohort (n = 143) the corresponding rates were 3%, 10% and 14%, respectively. Conclusion Using disease prognosis allows a rational approach to inclusion criteria, discontinuation triggers and risk‐stratified management in AS.

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“…Re-biopsies were performed at protocol-driven time points (12 months and 36 months) or were triggered earlier by a clinical suspicion for progression based on three consecutive rises in PSA level or suspected MRI progression. This was defined as PRECISE score ≥ 4 or MRI-based criteria (increase in the number of lesions, increase in lesion size or stage progression) for the scans which predated PRECISE scoring system, as previously reported [10]. In cases where an MRI lesion was visible, a targeted MRI-US image-fusion TP biopsy was performed with 2-4 cores per target in addition to acquiring 24 background systematic cores (2 per each of 12 anatomic sectors) [11].…”

Section: Active Surveillance Follow-up and Progressionmentioning

confidence: 99%

MRI-derived PRECISE scores for predicting pathologically-confirmed radiological progression in prostate cancer patients on active surveillance

et al. 2020

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Objectives To assess the predictive value and correlation to pathological progression of the Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) scoring system in the follow-up of prostate cancer (PCa) patients on active surveillance (AS). Methods A total of 295 men enrolled on an AS programme between 2011 and 2018 were included. Baseline multiparametric magnetic resonance imaging (mpMRI) was performed at AS entry to guide biopsy. The follow-up mpMRI studies were prospectively reported by two sub-specialist uroradiologists with 10 years and 13 years of experience. PRECISE scores were dichotomized at the cut-off value of 4, and the sensitivity, specificity, positive predictive value and negative predictive value were calculated. Diagnostic performance was further quantified by using area under the receiver operating curve (AUC) which was based on the results of targeted MRI-US fusion biopsy. Univariate analysis using Cox regression was performed to assess which baseline clinical and mpMRI parameters were related to disease progression on AS. Results Progression rate of the cohort was 13.9% (41/295) over a median follow-up of 52 months. With a cut-off value of category ≥ 4, the PRECISE scoring system showed sensitivity, specificity, PPV and NPV for predicting progression on AS of 0.76, 0.89, 0.52 and 0.96, respectively. The AUC was 0.82 (95% CI = 0.74–0.90). Prostate-specific antigen density (PSA-D), Likert lesion score and index lesion size were the only significant baseline predictors of progression (each p < 0.05). Conclusion The PRECISE scoring system showed good overall performance, and the high NPV may help limit the number of follow-up biopsies required in patients on AS. Key Points • PRECISE scores 1–3 have high NPV which could reduce the need for re-biopsy during active surveillance. • PRECISE scores 4–5 have moderate PPV and should trigger either close monitoring or re-biopsy. • Three baseline predictors (PSA density, lesion size and Likert score) have a significant impact on the progression-free survival (PFS) time.

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Progression and treatment rates using an active surveillance protocol incorporating image‐guided baseline biopsies and multiparametric magnetic resonance imaging monitoring for men with favourable‐risk prostate cancer

Cited by 50 publications

References 33 publications

Reasons for Discontinuing Active Surveillance: Assessment of 21 Centres in 12 Countries in the Movember GAP3 Consortium

Reasons for Discontinuing Active Surveillance: Assessment of 21 Centres in 12 Countries in the Movember GAP3 Consortium

Using prognosis to guide inclusion criteria, define standardised endpoints and stratify follow‐up in active surveillance for prostate cancer

MRI-derived PRECISE scores for predicting pathologically-confirmed radiological progression in prostate cancer patients on active surveillance

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