SUMMARY OF CHANGES Update: April 8, 2008 (Broadcast 4/8/08)


RTOG 0621, Adjuvant 3DCRT/IMRT in Combination with Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial

Study Chair: Mark Hurwitz, M.D., (508) 235-5700, mhurwitz@lroc.harvard.edu

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RTOG 0621 has been updated as follows:

Instructions for the submission of the Canadian study agent shipment form were updated in Sections 5.3.3, 7.5.6, 7.5.7.2, and Appendix VII.

Other Changes

Title page: The name and contact information of the study statistician was added to update the protocol to current RTOG standard.

Section 7.5.7.1: The contact information for Sanofi-Aventis was updated.

Section 12.1: The interim Follow-up Form (FS) was deleted. Data will be submitted via the Initial Follow-Up Form (F0) for which the timeframe was updated.

Appendix II: The footnote, "*And as needed based on reporting requirements", was deleted as it is no longer RTOG standard and as adverse event evaluations are specified in the protocol text.



Note: These are editorial/administrative changes to the protocol. NCI now requires that these changes be documented on the protocol title page as "Update Date".