Objectives: In the early detection of prostate cancer (CaP) uncertainty exists concerning the most appropriate biopsy procedure. Within the European Randomized Study of Screening for Prostate Cancer (ERSPC) lateralized sextant biopsies are used. False-negative results of sextant biopsies have led to the extensive use of procedures using 12 or more biopsy cores. The ERSPC offers the opportunity to study the yield of repeat biopsies after 4 years in men who had negative sextant biopsies and a prostate-specific antigen (PSA) level of 4.0 mg/mL or more at the first screening round.
Methods: Between August 1996 and May 1998, a total of 6876 men (age 55 to 74 years) were randomized to the screening arm and actually underwent screening. The numbers and levels of biopsy indicators, as well as possible predictors for biopsy outcome, in the second screening round, such as prostate volume, volume change over time, prostate-specific antigen density (PSAD), PSA velocity, and age, were calculated and compared for participants with positive and negative biopsies in round 2. The positive predictive value (PPV) and detection rates, as well as parameters of aggressiveness, were evaluated for second-round biopsy-detected and interval CaP cases.
Results: Of the 728 men with a PSA level of 4.0 mg/mL or more who underwent biopsy at initial screening, 553 were eligible for a second screening visit after 4 years. Of these, 272 (49.2%) actually underwent screening. Eighteen CaP cases were detected with 217 biopsies, indicated by a PSA level of 3.0 ng/mL or more (PPV 8.3%). Eight interval cases were identified by linking to the Cancer Registry. These 26 cases would have increased the PPV and detection rate of the initial screening round from 36.1% to 39.7% and from 3.8% to 4.2%, respectively. Most of these cases (23 of 26 or 88.5%) were organ confined and amenable to potentially curative treatment.
Conclusions: Although the results of this study may have been biased by the low rate of availability/eligibility of participants for rescreening (after 4 years), the proportion of cancers detected after a previous lateral sextant biopsy indicated by a PSA value of 4.0 mg/mL or more (PPV 8.3%) fell far short of the overall PPV at rescreening (PPV 20%). The features of most cancers that were possibly missed during the first round allowed a potentially curative approach. The ERSPC study group found no reason to change the ERSPC protocol.