Prostate Specific Antigen Testing and Digital Rectal Examination Before and During a Randomized Trial of Screening for Prostate Cancer: European Randomized Study of Screening for Prostate Cancer, Rotterdam

Beemsterboer, Petra M. M.; Koning, Harry J. de; Kranse, Ries; Trienekens, P.; Maas, P.J. van der; SCHR??DER, FRITZ H.

doi:10.1097/00005392-200010000-00019

Cited by 12 publications

(15 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This phenomenon of self-referral-induced contamination has been observed, for example, in a prostate cancer screening trial where the serum prostate-specific antigen testing rate in the control arm was approximately 60% higher than that in the general population (56). Contamination due to additional breast cancer screening in the control arm would obscure a potential difference in interval cancer rate between the trial arms.…”

Section: Special Report: Mr Imaging As Additional Screening Modality mentioning

confidence: 94%

MR Imaging as an Additional Screening Modality for the Detection of Breast Cancer in Women Aged 50–75 Years with Extremely Dense Breasts: The DENSE Trial Study Design

Emaus¹,

Bakker²,

Peeters³

et al. 2015

Radiology

View full text Add to dashboard Cite

Women with extremely dense breasts have an increased risk of breast cancer and lower mammographic tumor detectability. Nevertheless, in most countries, these women are currently screened with mammography only. Magnetic resonance (MR) imaging has the potential to improve breast cancer detection at an early stage because of its higher sensitivity. However, MR imaging is more expensive and is expected to be accompanied by an increase in the number of false-positive results and, possibly, an increase in overdiagnosis. To study the additional value of MR imaging, a randomized controlled trial (RCT) design is needed in which one group undergoes mammography and the other group undergoes mammography and MR imaging. With this design, it is possible to determine the proportion of interval cancers within each study arm. For this to be an effective screening strategy, the additional cancers detected at MR imaging screening must be accompanied by a subsequent reduction in interval cancers. The Dense Tissue and Early Breast Neoplasm Screening, or DENSE, trial is a multicenter RCT performed in the Dutch biennial population-based screening program (subject age range, 50-75 years). The study was approved by the Dutch Minister of Health, Welfare and Sport. In this study, mammographic density is measured by using a fully automated volumetric method. Participants with extremely dense breasts (American College of Radiology breast density category 4) and a negative result at mammography (Breast Imaging Recording and Data System category 1 or 2) are randomly assigned to undergo additional MR imaging (n = 7237) or to be treated according to current practice (n = 28 948). Participants provide written informed consent before the MR imaging examination, which consists of dynamic breast MR imaging with gadolinium-based contrast medium and is intended to be performed for three consecutive screening rounds. The primary outcome is the difference in the proportions of interval cancers between the study arms. Secondary outcomes are the number of MR imaging screening-detected cancers, proportions of false-positive results, diagnostic yield of MR imaging, tumor characteristics, quality of life, and cost effectiveness.q RSNA, 2015

show abstract

Section: Special Report: Mr Imaging As Additional Screening Modality mentioning

confidence: 94%

MR Imaging as an Additional Screening Modality for the Detection of Breast Cancer in Women Aged 50–75 Years with Extremely Dense Breasts: The DENSE Trial Study Design

Emaus¹,

Bakker²,

Peeters³

et al. 2015

Radiology

View full text Add to dashboard Cite

show abstract

“…In the Dutch healthcare system, the GP is the gatekeeper for the specialized medical care, which is accessible only after a referral by the GP. Published data on referral for PSA test by GPs participating in the Dutch Sentinel Practice Network were used for the evaluation of the background rate of PSA testing at national level 5, 7. The PSA assay used in the GP laboratory was the PSA‐2 (Bayer Diagnostics, Tarrytown, NY); in the ERSPC trial laboratory, the Access of Hybritech (Beckman‐Coulter Inc., San Diego, CA).…”

Section: Methodsmentioning

confidence: 99%

“…By linking the trial records to the PSA database of the GP laboratory, the number and outcome of PSA tests requested by the GPs in both the control and screening arms were obtained. The linkage procedure has been described previously,5 but was slightly modified in the current study in order to obtain all PSA tests (and not random ones) of the respective participants. Briefly, 1 9‐ and 2 8‐character keys consisting of a combination of the first initials plus characters from the subject's last name and the date of birth (ddmmyyyy) were made for each record in both the trial and the PSA database of the GP laboratory.…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Effective PSA contamination in the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer

Otto

Cruijsen

Liem

et al. 2003

Intl Journal of Cancer

View full text Add to dashboard Cite

The extent of effective prostate-specific antigen (PSA) contamination in the Rotterdam section of the ongoing European Randomized Study of Screening for Prostate Cancer (ERSPC) trial was evaluated and defined as when opportunistic PSA testing of > 3.0 ng/ml was followed by biopsy, similar to the regular procedure within the trial. Records of participants aged 55-74 years at entry were linked to the regional database of the general practitioner (GP) laboratory to obtain PSA tests requested by GPs in the period 1 July 1997 to 31 May 2000 (2.9 years), and to the national pathology database to quantify the number of biopsies. All men randomized were included, only those with prostate cancer screen-detected or clinically diagnosed before July 1997 were omitted from the analyses. 2,895 out of the 14,349 men (20.2%) in the control arm and 1,981 out of the 14,052 men (14.1%) in the screening arm were PSA-tested, at an average annual rate of 73 and 52 per 1,000 person-years, respectively. These rates were higher than those recorded at the national and regional levels, 33 and 38 per 1,000 person-years, respectively. Opportunistic PSA testing in the control arm reached a peak within the first months of randomization, after which it decreased to around 70 per 1,000 person-years. An opposite pattern was observed in the screening arm, where participants already had received the scheduled screening within the trial. The proportion of men in the control arm with PSA > 3.0 ng/ml followed by biopsy and prostate cancer was 7-8% and 3%, respectively (3% and 0.4 -0.6% in the screening arm), over the whole study period. Over a 4-year rescreening interval, the average PSA and effective contamination amount were approximately 28% and 10%, respectively. PSA testing in the control arm in the Rotterdam ERSPC section is high, but was not followed by a substantial increase in prostate biopsies. Although the reasons for ordering PSA test or indicating biopsy are unknown, effective PSA contamination in the Rotterdam ERSPC section is low and not likely to jeopardize the power of the trial.

show abstract

“…the proportion of men invited and actually randomised) was 49%. The written informed consent also granted permission for exchange of information with the participant's general practitioner, and for retrieval of relevant follow-up data from the Causes of Death Registry, General Practitioner Laboratories, 7,8 the Cancer Registry, and from the Nationwide Network and Registry of Histopathology and Cytopathology (PALGA). Population and mortality data for the male population of the municipalities in which the participants were recruited were provided by Statistics Netherlands as ve-year age group tabulation lists -1994-1999 -the period in which recruitment took place.…”

Section: Study Populationmentioning

confidence: 99%

Low all-cause mortality in the volunteer-based Rotterdam section of the European randomised study of screening for prostate cancer: self-selection bias?

2004

View full text Add to dashboard Cite

Objectives:The likelihood of self-selection bias in a cohort of men that entered the volunteer-based randomised prostate cancer screening trial was assessed. In addition, the accuracy of the randomisation was evaluated by comparison amongst the trial arms. Setting:The Rotterdam section of the European Randomised Study of Screening for Prostate Cancer (ERSPC). Participants were recruited from population registries and randomised after receipt of written informed consent (49% participation rate). Methods:Data from 37,614 men who entered the Rotterdam trial between June 1994 and July 1999 were linked to the Causes of Death Registry of Statistics Netherlands. For the assessment of selfselection bias, mortality in the trial cohort and the area of Rotterdam was compared by calculating standardised mortality ratios (SMRs, 95% con dence interval [CI]). Comparisons between the screening and the control arm were made by means of relative risk (RR).Results: There were a total of 1661 deaths (4.4%) in the trial cohort, during an average follow-up time of 2.8 years. The observed number of deaths in the two arms combined was lower than expected (SMR 86.7%, 95% CI 81.6-92.1), which was re ected in the major cause of death categories, especially in all malignant neoplasms. No difference was observed in the all-cause mortality rate among the screening and control arm, aged 55-69 years at entry (RR 1.00, 95% CI 0.89-1.12), nor when all causes, excluding prostate cancer mortality, were considered. Conclusions:The preliminary results show that the screening and the control arm were comparable, but men recruited for the trial seemed healthier than men in the target population.

show abstract

Prostate Specific Antigen Testing and Digital Rectal Examination Before and During a Randomized Trial of Screening for Prostate Cancer: European Randomized Study of Screening for Prostate Cancer, Rotterdam

Abstract: PSA testing was moderate in the control arm but if different men undergo this test each year, the contamination rate may become rather high. In the final analysis of mortality PSA testing should be considered.

Cited by 12 publications

References 13 publications

MR Imaging as an Additional Screening Modality for the Detection of Breast Cancer in Women Aged 50–75 Years with Extremely Dense Breasts: The DENSE Trial Study Design

MR Imaging as an Additional Screening Modality for the Detection of Breast Cancer in Women Aged 50–75 Years with Extremely Dense Breasts: The DENSE Trial Study Design

Effective PSA contamination in the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer

Low all-cause mortality in the volunteer-based Rotterdam section of the European randomised study of screening for prostate cancer: self-selection bias?

Contact Info

Product

Resources

About