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Data was collected on procedures that were part of a diagnostic work-up for prostate cancer and for staging procedures following a diagnosis. Two different types of events triggered the collection of diagnostic procedure information:

  1. Screens suspicious for prostate cancer: Among approximately 36,000* men screened once a year for up to 6 years, there were about 23,000 screening PSA exams or Digital Rectal Exams (DREs) suspicious for prostate cancer. These "positive" exams triggered further diagnostic follow-up, which was systematically captured, in most cases, for up to one year following the screen. Any positive screen among the PSA, DRE and, less frequently a QA exam would refer a participant to further follow-up. This information was captured regardless of the eventual diagnosis.
  2. Confirmed diagnoses of prostate cancer: When a participant was diagnosed with prostate cancer within the trial period, procedures that were part of a diagnostic work-up that occurred in the year leading up to that diagnosis were captured in the data.

Therefore, if a participant had a diagnostic procedure during the trial such that it was neither one year following a positive screen nor one year prior to a prostate cancer diagnosis, that information was not captured. As such, the only diagnostic procedures captured in the control arm are those that eventually lead to a prostate cancer diagnosis.

For most purposes, diagnostic procedure data can be obtained within the Prostate dataset. Additional details can be found in the Prostate Diagnostic Procedures dataset (one record per procedure per person) and the Prostate Medical Complications dataset (one record per medical complication per person).

Summary Available Data
  • ~96,000 procedures among ~15,000 men
  • Collected for the year following a positive screen or the year preceding a prostate cancer diagnosis
  • Collected in the intervention arm for men with prostate cancer or screens suspicious for prostate cancer. (~71,000 procedures among ~11,000 participants)
  • Collected in the control arm only for men with prostate cancer. (~26,000 procedures among ~4200 participants)
  • Collected on DEP (Diagnostic Evaluation - Prostate) forms:
  • Whether screens prompted diagnostic procedure(s)
  • Whether screens prompted biopsy
  • Type of biopsy
  • Available in diagnostic procedures dataset:
    • Types of procedures
    • Days from randomization to procedure
    • PSA level (for PSA exams not part of the screening protocol)
    • Prostate dimensions and volume
    • Form version used to capture information

*38,000 men were randomized for screening, but 2,000 never completed screening.