Prospective Validation of Active Surveillance in Prostate Cancer: The PRIAS Study

Bergh, Roderick C.N. van den; Roemeling, Stijn; Roobol, Monique J.; Roobol, Wouter; Schröder, Fritz H.; Bangma, Chris H.

doi:10.1016/j.eururo.2007.05.011

Cited by 216 publications

(144 citation statements)

References 20 publications

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“…The criteria for low risk are ≤cT2c, PSA ≤10 ng/mL and Gleason score ≤6. In HAROW, we modified the variables by using the enrolment criteria of the PRIAS study [18], the largest prospective study on AS to date. These criteria additionally include a PSA density of ≤0.2 ng/mL/mL and <3 positive biopsies.…”

Section: Methodsmentioning

confidence: 99%

Active surveillance in localized prostate cancer: comparison of incidental tumours (T1a/b) and tumours diagnosed by core needle biopsy (T1c/T2a): results from the HAROW study

Herden

Wille

Weißbach³

2015

BJU International

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ObjectiveTo conduct a comparative prospective analysis of patients with incidental T1a/T1b prostate cancer (IPCa) and those with prostate cancer (PCa) diagnosed by core needle biopsy, treated by active surveillance (AS), with regard to inclusion criteria, progression and switch to deferred treatment. Patients and MethodsThe HAROW study is an observational outcomes research study on the management of localized PCa. Treating urologists reported clinical variables and information on therapy and clinical course of disease at 6-month intervals. With respect to therapy, only recommendations were made; the final decision on the therapeutic method rested with the treating physician. ResultsOut of 2 957 patients included in the HAROW study, 447 chose AS. The median follow-up was 28.3 months. T1a, T1b, T1c and T2a disease were diagnosed in 81, 18, 292 and 56 patients, respectively. Patients in the IPCa group had lower prostate-specific antigen (PSA) levels (4.2 vs 6.1 ng/mL) and more comorbidities than those diagnosed by core needle biospy. The IPCa group also had fewer re-biopsies (25.3 vs 43.2%) and fewer changes to invasive treatment (12.1 vs 25.9%). No significant differences were found with respect to the criteria for discontinuation, subsequent therapies and histological findings after radical prostatectomy. ConclusionUrologists are highly inclined to use AS as a therapeutic option in IPCa. More patients with IPCa than those diagnosed after core needle biopsy continued on AS, which was also associated with the indication for a re-biopsy being less stringently observed.

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Section: Methodsmentioning

confidence: 99%

Active surveillance in localized prostate cancer: comparison of incidental tumours (T1a/b) and tumours diagnosed by core needle biopsy (T1c/T2a): results from the HAROW study

Herden

Wille

Weißbach³

2015

BJU International

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“…The criteria for eligibility for PRIAS aim to select asymptomatic, small, localized, welldifferentiated prostate cancer and consist of: histologically confirmed adenocarcinoma of the prostate, no previous treatment, fit for curative treatment, clinical stage T1C or T2, a PSA level of ≤ 10.0 ng/mL, a PSA density of < 0.2 ng/mL/mL, a Gleason score of 3 + 3 = 6, or more favourable, and one or two biopsy cores invaded with prostate cancer [12].…”

Section: Methodsmentioning

confidence: 99%

“…The 'Prostate Cancer Research International: Active Surveillance (PRIAS) study [12] is an international prospective observational study originating from the European Randomized Study of Screening for Prostate Cancer (ERSPC) [13]. PRIAS offers a protocol for the inclusion and follow-up of men, which is applied by a webbased instrument [14].…”

Section: Introductionmentioning

confidence: 99%

Short‐term outcomes of the prospective multicentre ‘Prostate Cancer Research International: Active Surveillance’ study

et al. 2010

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a Gleason score of ≤ 3 + 3 = 6, and one or two positive biopsy cores, were analysed. The follow-up protocol consisted of frequent PSA measurements, digital rectal examinations, and standard repeat biopsies (the first after 1 year). The primary outcome is survival free of active therapy; the secondary endpoints are reasons for stopping AS, findings in 1-year repeat biopsies, and outcomes after radical prostatectomy (RP). RESULTSPatients were included between December 2006 and July 2008. The median (25-75th percentile) follow-up after diagnosis was 1.02 (0.6-1.5) years. The 2-year survival rate free from active therapy was 73%. Of the 82 men who changed to active therapy during the follow-up, 68 (83%) did so based on the protocol. Of the 261 repeat biopsies available for analysis, 90 (34%) showed no cancer, while 57 (22%) showed a Gleason score of > 6 or more than two positive biopsy cores. There was a relatively unfavourable PSA doubling time of 0-10 years in 53% (102/194) and 62% (33/53) of men with favourable and unfavourable re-biopsy results, respectively. After RP, four of 24 (17%) men had T3 disease and 12 (50%) had a Gleason score of > 6. CONCLUSIONAS seems feasible, but mortality outcomes are unknown. A strict follow-up protocol including standard 1-year repeat biopsies resulted in a quarter of men stopping AS after 2 years.

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“…The costs for radical prostatectomy and radiation therapy are obtained from literature (Malmberg et al, 1997;Perez et al, 1997;Burkhardt et al, 2002;Makhlouf et al, 2002) and own hospital data. To estimate the costs of active surveillance the protocol of the PRIAS study (van den Bergh et al, 2007) was used: During 7 years, 19 PSA tests, 10 digital rectal examination (DRE) and 4 biopsies are scheduled. Finally, the costs of advanced disease were based on chart review (Beemsterboer et al, 1999).…”

Section: Model Applicationmentioning

confidence: 99%

Overdetection, overtreatment and costs in prostate-specific antigen screening for prostate cancer

et al. 2009

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Background: Prostate cancer screening with prostate-specific antigen (PSA) has shown to reduce prostate cancer mortality in the European Randomised study of Screening for Prostate Cancer (ERSPC) trial. Overdetection and overtreatment are substantial unfavourable side effects with consequent healthcare costs. In this study the effects of introducing widespread PSA screening is evaluated. Methods: The MISCAN model was used to simulate prostate cancer growth and detection in a simulated cohort of 100 000 men (European standard population) over 25 years. PSA screening from age 55 to 70 or 75, with 1, 2 and 4-year-intervals is simulated. Number of diagnoses, PSA tests, biopsies, treatments, deaths and corresponding costs for 100 000 men and for United Kingdom and United States are compared. Results: Without screening 2378 men per 100 000 were predicted to be diagnosed with prostate cancer compared with 4956 men after screening at 4-year intervals. By introducing screening, the costs would increase with 100% to €60 695 000. Overdetection is related to 39% of total costs (€23 669 000). Screening until age 75 is relatively most expensive because of the costs of overtreatment. Conclusion: Introduction of PSA screening will increase total healthcare costs for prostate cancer substantially, of which the actual screening costs will be a small part.

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Prospective Validation of Active Surveillance in Prostate Cancer: The PRIAS Study

Cited by 216 publications

References 20 publications

Active surveillance in localized prostate cancer: comparison of incidental tumours (T1a/b) and tumours diagnosed by core needle biopsy (T1c/T2a): results from the HAROW study

Active surveillance in localized prostate cancer: comparison of incidental tumours (T1a/b) and tumours diagnosed by core needle biopsy (T1c/T2a): results from the HAROW study

Short‐term outcomes of the prospective multicentre ‘Prostate Cancer Research International: Active Surveillance’ study

Overdetection, overtreatment and costs in prostate-specific antigen screening for prostate cancer

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