To Do for the December 2007 Report

  1. DONE Open report:(May 2006) Add to the scheduled biopsy analysis the proportion of positive cores and the total cancer volume (derived from the length of cancer and the cores).
  2. DONE (October 2006): For biopsies arising from surgery, the next report should exclude surgeries done for treatment of prostate cancer.
  3. DONE (October 2006): In the next report, a graph depicting the smooth relationship between the probability that a patient refused to have a 2-year biopsy (from among those patients who were known to have a biopsy or for whom a reason for not having it was known) against the 18-month PSA should be included, stratified by A vs.~B.
  4. DONE (June 2007, Matt's notes): Table 23, page 62 - For prostate cancer family history, we see some differences. For example we are getting n=259 subjects with at least one brother having prostate cancer, and 298 associated ages of brothers; Table 23 shows n=298 for brother. Can you please check to see whether the n=298 corresponds to numbers of subjects, or numbers of ages of brothers (the latter can be larger than the former if a subject has multiple brothers with prostate cancer).SKE: Regarding item d), n=298 is the total number of brothers, not subjects who have brothers. This table is slightly confusing. I'll work on it after the meeting.
  5. DONE Create a new summary (X4 - see Matt's email) of subjects with prostate cancer diagnosis at surgery (central pathology data).
  6. DONE Implement sess=99 for PSA and other summaries. (See design document for more details).

Matt's tables due to June-2007 Meeting

  1. DONE B8: Major protocol violations (open report)
  2. DONE B14: Summary of Family History of Prostate Cancer
  3. DONE E4: Summary of Subjects With Prostate Cancer by Procedure Type (Central Pathology Data)
  4. DONE E5: Summary of Subjects Diagnosed as Suspicious by Procedure Type
  5. DONE E7: Summary of Biopsy-Detectable Prostate Cancer (Crude Rate Approach)
  6. DONE E9: Summary of Biopsy-Detectable Prostate Cancer (Modified Crude Rate Approach)
  7. DONE E41: Summary of Biopsy-Detectable Prostate Cancer (Crude Rate Approach) Based on Central and Local Pathology Laboratory Results
  8. DONE E42: Summary of Biopsy-Detectable Prostate Cancer (Modified Crude Rate Approach) Based on Central and Local Pathology Laboratory Results
  9. DONE E43: Summary of Number of Cores Sampled
  10. DONE E44: Summary of Number of Cancer Positive Cores
  11. DONE E45: Summary of Percentage of Core Involved
  12. DONE E46: Summary of Volume of Cancer
  13. DONE E47: Summary of Number of Subjects by Overall Gleason Score for All Biopsies (Central Lab)
  14. DONE E50: Summary of Number of Subjects by Overall Gleason Score for All Biopsies (Central+Local Lab)

Plan for IDMC outputs for December 2007

Date Event
DONE 20 June 2007 Intermediate data transfer to SDC
DONE 10 September 2007 Intermediate data transfer to SDC
DONE 05 November 2007 Final data transfer to SDC
DONE 26 November 2007 SDC sends outputs to IDMC members
DONE 3 December 2007 IDMC meeting; place: Atlanta
Topic revision: r1 - 04 Dec 2007, SvetlanaEden
 

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