The story of the European Randomized Study of Screening for Prostate Cancer.
Explore the source record for details and available documents.
Biomedical subjects
Publications and source records attributed to ERSPC.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
OBJECTIVE: To determine the rate of conversion of prostate-specific antigen (PSA) to values of > 4 ng/mL in a normal male population. PATIENTS AND METHODS: In men with an initial PSA level of < 4 ng/mL the probability of having a PSA of > or = 4 ng/mL and its relationship with the age at first PSA test, baseline PSA level and time to the determination was evaluated. Statistical methods were used to correct for the within-subject variability across many PSA determinations. RESULTS: In all, 45433 PSA tests in 21169 men with an initial PSA of < 4 ng/mL were available. Overall, in 960 men (4.5%) the PSA level changed to > or = 4 ng/mL. The lowest chance was for men aged < 55 years with an initial PSA of < 1 ng/mL and a new PSA determination during the first 18 months (0.952 conversions per 1000 men) while the highest was for men aged < 55 years with an initial PSA level of > 2.5 ng/mL (395 conversions per 1000 men). There was a significant and independent relationship between conversion and the interval between determinations, with conversion being 3.33 times more frequent during 18-42 months than with the reference category (< 18 months) and 5.23 times more frequent during > 42 months. The probability of conversion independently increased by 3 lambda for every additional year of age. Every unit of basal PSA multiplied by 6.48 the probability of conversion. CONCLUSIONS: The risk for conversion to a PSA of > or = 4 ng/mL can be anticipated from the patient's age and initial PSA level. Re-screening before 4 years after the first round can be useless for men with an initial PSA of < 1 ng/mL. Four-year intervals could be inadequate for men with an initial PSA of > 2.5 ng/mL if conversion to > 4 ng/mL is to be avoided.
From 1992-2001, 7 countries in Europe gradually recruited men for the European Randomised Screening for Prostate Cancer (ERSPC) trial. Centres recruit different age groups and have different designs for recruiting and countries have different underlying risks for prostate cancer. Recruitment has reached 163,126 men aged 55-69 at entry now. Our purpose was to calculate the power of the trial and at what point in time can statistically significant differences in prostate cancer mortality be expected. Recruitment data were collected from the screening centres. We calculated the expected number of prostate cancer deaths in each follow-up year, based on national statistics and expected rate in trial entrants. The power was calculated using different assumptions on intervention effect and contamination rate and also if the ERSPC trial would cooperate with other trials. With an assumed 25% intervention effect in men actually screened and a 20% contamination rate, the trial will reach a power of 0.86 in 2008. With an assumed intervention effect of 40%, the power reaches 0.90 in 2003-2004. Pooling data with those of the Prostate, Lung, Colorectal and Ovary (PLCO) trial early is expected to improve the power to 79% (20% intervention effect) to 92% (40% intervention effect PLCO). Adding more centres with compliance rates lower than 45% decreases the power of the trial. The ERSPC trial has sufficient power to detect a significant difference in prostate cancer mortality between the 2 arms if the true reduction in mortality by screening is 25% or more or if contamination remains limited to 10% if the true effect is 20% or more. If early detection and treatment turns out to have a stronger effect as may be suggested by observational data, the ERSPC trial is likely to conclusively show that within the next 5 years.