Active Surveillance for Prostate Cancer in a Real-life Cohort: Comparing Outcomes for PRIAS-eligible and PRIAS-ineligible Patients

In daily practice, a wider range of patients with prostate cancer (PCa) are selected for active surveillance (AS) compared to those in AS trials, including higher-risk patients. However, less is known about the outcomes for off-protocol selected PCa patients who opt for AS. To compare AS outcomes fo...

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Veröffentlicht in:European urology oncology 2018-08, Vol.1 (3), p.231-237
Hauptverfasser: Soeterik, Timo F.W., van Melick, Harm H.E, Dijksman, Lea M., Biesma, Douwe H., Witjes, J. Alfred, van Basten, Jean-Paul A.
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container_end_page 237
container_issue 3
container_start_page 231
container_title European urology oncology
container_volume 1
creator Soeterik, Timo F.W.
van Melick, Harm H.E
Dijksman, Lea M.
Biesma, Douwe H.
Witjes, J. Alfred
van Basten, Jean-Paul A.
description In daily practice, a wider range of patients with prostate cancer (PCa) are selected for active surveillance (AS) compared to those in AS trials, including higher-risk patients. However, less is known about the outcomes for off-protocol selected PCa patients who opt for AS. To compare AS outcomes for higher-risk patients and very low-risk patients in a large cohort of patients diagnosed with PCa. Patients diagnosed with PCa between 2008 and 2015 with clinical stage ≥T1c and managed with AS at six large teaching hospitals. AS included regular prostate-specific antigen (PSA) testing (every 3–6 mo) and a confirmatory biopsy 1 yr after diagnosis and every 3 yr thereafter. Using the inclusion criteria of the PRIAS study, outcomes for PRIAS-eligible patients (ie, cT1c–T2, Gleason sum score ≤6, ≤2 positive biopsy cores, PSA ≤10 ng/ml, and PSA density
doi_str_mv 10.1016/j.euo.2018.03.015
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Alfred ; van Basten, Jean-Paul A.</creator><creatorcontrib>Soeterik, Timo F.W. ; van Melick, Harm H.E ; Dijksman, Lea M. ; Biesma, Douwe H. ; Witjes, J. Alfred ; van Basten, Jean-Paul A.</creatorcontrib><description>In daily practice, a wider range of patients with prostate cancer (PCa) are selected for active surveillance (AS) compared to those in AS trials, including higher-risk patients. However, less is known about the outcomes for off-protocol selected PCa patients who opt for AS. To compare AS outcomes for higher-risk patients and very low-risk patients in a large cohort of patients diagnosed with PCa. Patients diagnosed with PCa between 2008 and 2015 with clinical stage ≥T1c and managed with AS at six large teaching hospitals. AS included regular prostate-specific antigen (PSA) testing (every 3–6 mo) and a confirmatory biopsy 1 yr after diagnosis and every 3 yr thereafter. Using the inclusion criteria of the PRIAS study, outcomes for PRIAS-eligible patients (ie, cT1c–T2, Gleason sum score ≤6, ≤2 positive biopsy cores, PSA ≤10 ng/ml, and PSA density &lt;0.2 ng/ml/ml) were compared to outcomes for PRIAS-ineligible patients. Unfavourable outcomes following deferred surgery, biochemical recurrence, and risk of metastasis were calculated using univariate and multivariate Cox regression analyses. Time to tumour progression was established using survival analysis. Of the 1000 patients included and managed with AS, almost half of the patients (49%) had higher-risk disease characteristics than the PRIAS inclusion criteria. PRIAS-ineligible patients discontinued AS because of tumour progression significantly earlier than PRIAS-eligible patients (hazard ratio [HR] 1.74, 95% confidence interval [CI] 1.44–2.11); they also had a higher risk of positive surgical margins (odds ratio [OR] 2.15, 95% CI 1.11–4.17) and unfavourable pathological findings (OR 3.20, 95% CI 1.61–6.35) following deferred radical prostatectomy. PSA density ≥0.2 ng/ml/ml was the most important individual predictor and, in addition to a higher risk of tumour progression and unfavourable surgical outcomes, was also associated with a significantly higher risk of biochemical progression following deferred radical prostatectomy (OR 3.26, 95% CI 1.23–8.64). In the overall population, PSA density ≥0.2 ng/ml/ml was also associated with a higher risk of metastasis (HR 2.71, 95% CI 1.23–5.96). In this cohort, approximately half of the patients did not meet the inclusion criteria of the PRIAS study. These patients had a two- to threefold higher risk of disease progression and unfavourable outcomes following deferred prostatectomy. PSA density is an important individual predictor of unfavourable outcomes and should be taken into account when selecting patients for AS. A large proportion of patients with prostate cancer on active surveillance are not in the lowest risk group. These patients have a higher risk of experiencing tumour progression to a stage requiring curative intervention. They also have worse disease prognosis compared to patients on active surveillance in the lowest risk group. In a real-life cohort of prostate cancer patients managed with active surveillance, 49% did not meet the eligibility criteria of the PRIAS study. 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Alfred</creatorcontrib><creatorcontrib>van Basten, Jean-Paul A.</creatorcontrib><title>Active Surveillance for Prostate Cancer in a Real-life Cohort: Comparing Outcomes for PRIAS-eligible and PRIAS-ineligible Patients</title><title>European urology oncology</title><addtitle>Eur Urol Oncol</addtitle><description>In daily practice, a wider range of patients with prostate cancer (PCa) are selected for active surveillance (AS) compared to those in AS trials, including higher-risk patients. However, less is known about the outcomes for off-protocol selected PCa patients who opt for AS. To compare AS outcomes for higher-risk patients and very low-risk patients in a large cohort of patients diagnosed with PCa. Patients diagnosed with PCa between 2008 and 2015 with clinical stage ≥T1c and managed with AS at six large teaching hospitals. AS included regular prostate-specific antigen (PSA) testing (every 3–6 mo) and a confirmatory biopsy 1 yr after diagnosis and every 3 yr thereafter. Using the inclusion criteria of the PRIAS study, outcomes for PRIAS-eligible patients (ie, cT1c–T2, Gleason sum score ≤6, ≤2 positive biopsy cores, PSA ≤10 ng/ml, and PSA density &lt;0.2 ng/ml/ml) were compared to outcomes for PRIAS-ineligible patients. Unfavourable outcomes following deferred surgery, biochemical recurrence, and risk of metastasis were calculated using univariate and multivariate Cox regression analyses. Time to tumour progression was established using survival analysis. Of the 1000 patients included and managed with AS, almost half of the patients (49%) had higher-risk disease characteristics than the PRIAS inclusion criteria. PRIAS-ineligible patients discontinued AS because of tumour progression significantly earlier than PRIAS-eligible patients (hazard ratio [HR] 1.74, 95% confidence interval [CI] 1.44–2.11); they also had a higher risk of positive surgical margins (odds ratio [OR] 2.15, 95% CI 1.11–4.17) and unfavourable pathological findings (OR 3.20, 95% CI 1.61–6.35) following deferred radical prostatectomy. PSA density ≥0.2 ng/ml/ml was the most important individual predictor and, in addition to a higher risk of tumour progression and unfavourable surgical outcomes, was also associated with a significantly higher risk of biochemical progression following deferred radical prostatectomy (OR 3.26, 95% CI 1.23–8.64). In the overall population, PSA density ≥0.2 ng/ml/ml was also associated with a higher risk of metastasis (HR 2.71, 95% CI 1.23–5.96). In this cohort, approximately half of the patients did not meet the inclusion criteria of the PRIAS study. These patients had a two- to threefold higher risk of disease progression and unfavourable outcomes following deferred prostatectomy. PSA density is an important individual predictor of unfavourable outcomes and should be taken into account when selecting patients for AS. A large proportion of patients with prostate cancer on active surveillance are not in the lowest risk group. These patients have a higher risk of experiencing tumour progression to a stage requiring curative intervention. They also have worse disease prognosis compared to patients on active surveillance in the lowest risk group. In a real-life cohort of prostate cancer patients managed with active surveillance, 49% did not meet the eligibility criteria of the PRIAS study. 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Patients diagnosed with PCa between 2008 and 2015 with clinical stage ≥T1c and managed with AS at six large teaching hospitals. AS included regular prostate-specific antigen (PSA) testing (every 3–6 mo) and a confirmatory biopsy 1 yr after diagnosis and every 3 yr thereafter. Using the inclusion criteria of the PRIAS study, outcomes for PRIAS-eligible patients (ie, cT1c–T2, Gleason sum score ≤6, ≤2 positive biopsy cores, PSA ≤10 ng/ml, and PSA density &lt;0.2 ng/ml/ml) were compared to outcomes for PRIAS-ineligible patients. Unfavourable outcomes following deferred surgery, biochemical recurrence, and risk of metastasis were calculated using univariate and multivariate Cox regression analyses. Time to tumour progression was established using survival analysis. Of the 1000 patients included and managed with AS, almost half of the patients (49%) had higher-risk disease characteristics than the PRIAS inclusion criteria. 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subjects Active surveillance
Metastasis
Patient selection
Prostate cancer
Prostate-specific antigen density
Prostatectomy
title Active Surveillance for Prostate Cancer in a Real-life Cohort: Comparing Outcomes for PRIAS-eligible and PRIAS-ineligible Patients
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