SUMMARY OF CHANGES Update: February 13, 2008 (Broadcast 2/13/08)
RTOG 0534, "A Phase III Trial Of Short Term Androgen Deprivation With Pelvic Lymph Node Or Prostate Only Radiotherapy (SPPORT) In Prostate Cancer Patients With A Rising PSA After Radical Prostatectomy"

Study Chair: Alan Pollack, MD, PhD, (215) 728-2940, alan.pollack@fccc.edu

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RTOG 0534 has been updated as follows:

Title page: The acronym in the title was changed from "SPORT" to "SPPORT"; this change also was made in the title on the Schema page and on the first page of Appendix I, the sample consent.

Index: Appendix VIII, the PSA Doubling Time Worksheet, was deleted, and the subsequent appendix was renumbered appropriately.

Section 3.1.5: Since Appendix VIII, the PSA Doubling Time Worksheet, was deleted, instructions for calculating PSA Doubling Time were added to this section. No change to eligibility was made.

Section 7.8: The Adverse Event reporting guidelines were updated to current RTOG standard.

Section 10.0: The RTOG Tissue Bank has been relocated. The phrase, "RTOG Tissue Bank" was updated with the name of the new facility, "RTOG Biospecimen Resource" throughout this section. In addition, Section 10.1 was updated with the location of the new facility, the University of California San Francisco, and contact information was provided for the RTOG Biospecimen Resource in Section 10.3.2 and Appendices VI and VII.

Section 10.3:

• Consistent with the renumbering of the appendices on the Index page, in Section 10.3.1.1, Appendix V was changed to Appendix VI, and in Section 10.3.1.2, Appendix VI was changed to Appendix VII.


• Section 11.9.5: Consistent with the renumbering of appendices on the Index page, the reference to Appendix IX was changed to Appendix VIII.

Section 12.2 was updated per current ITC digital data submission guidelines.

Section 13.5.6: The reference to Appendix II was deleted, as it was seen as unnecessary.

Appendix II, Study Parameter Table:

• In the pretreatment column, the word, "Recommended" was replaced by "If patient consents" for clarity for the following assessments: Alk phos, tissue for banking, blood, urine for banking, and beta amyloid.


• Under "Follow up After RT", in the "Annually thereafter" column, the phrase, "For 5 yrs post-RT" was added for clarity for the following assessments: blood, urine for banking and beta amyloid.


• Under "Long-term Follow up", an instruction, "As indicated in Sections 11.2 and 11.3", was added for clarity.

Appendix V, CTSU Logistics: At the request of the CTSU, hours of operation were changed from 8:00 am-8:00 pm to 9:00 am-5:30 pm Eastern Time in the following pages:

• Page 1, under "Address And Contact Information For RTOG-0415, CTSU Patient Registration";


• Page 2, under "CTSU Procedures for Patient Enrollment, #3".

Appendix VIII, Neurocognitive Battery: Consistent with the renumbering of appendices on the Index page, all REFERENCES to Appendix IX were changed to Appendix VIII. In addition, "NCI #" was added after "Institution Number/Name", and under "For Dr. Meyer's Use Only", the fax number was corrected.