and transrectal ultrasound were emerging technologies that had been investigated only in men already diagnosed with the disease. These new methods, of unknown potential for early detection, were combined with the previously studied digital rectal examination in a coordinated, multimodality intervention strategy.To demonstrate the range of settings in which advancing early detection of prostate cancer might be possible, the ACS-NPCDP involved a multidisciplinary group of investigators from different medical facilities, including community hospitals, university medical centers, cancer centers, and private medical practices. An annual examination protocol was established to replicate periodic testing, and healthy men at risk of prostate cancer were recruited to participate for 5 years.Although the ACS-NPCDP was established as a demonstration project, the project design incorporated several detection efficacy variables, such as sensitivity, specificity, and predictive value. Analyses of these outcomes were reported in several publications as the project progressed. [1][2][3][4] This report reviews the status and summary outcomes of the ACS-NPCDP. In addition, the patterns of detection and outcome in the ACS-NPCDP are compared with contemporaneous patterns of prostate cancer in the United States documented in the National Cancer Database (NCDB).
BackgroundTen clinical centers recruited 2,999 healthy men age 55 to 70 years who had no history of prostate cancer, were not already under evaluation for possible C A C a n c e r J C l i n 1 9 9 7 ; 4 7 : 2 6 5 -2 7 2Vol. prostate cancer, and provided informed consent before their participation. The participants were recruited from community populations by means of public service announcements and similar promotions. Details of the protocol have been described. 1,4 Blood was drawn for PSA assessment before digital rectal examination or transrectal ultrasound was done. Real-time ultrasonography was performed in axial and sagittal projections. A suspicious outcome of digital rectal examination was defined by the presence of significant induration, nodularity, or asymmetry.If a suspicious area was defined by transrectal ultrasound or digital rectal examination, participants were requested to submit to a transrectal ultrasound-guided biopsy. When only the digital rectal examination could locate the suspicious area, a digitally guided biopsy was performed. A PSA level of more than 4.0 ng/ml was the usual indicator of the need for further evaluation.The most common exception to this guideline occurred when the transrectal ultrasound and digital rectal examination were normal and the elevation in PSA was consistent with benign gland enlargement. In these instances subjects would continue to be followed by transrectal ultrasound, digital rectal examination, and PSA assessment without immediate biopsy.Subjects who had normal biopsy outcomes continued to be monitored by transrectal ultrasound, digital rectal examination, and PSA level; they underwent biopsy again if these examinations...