SUMMARY OF CHANGES
Update Date: May 11, 2007
RTOG 0526, "A Prospective Phase II Trial Of Transperineal Ultrasound-Guided Brachytherapy For Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy"
Study Chair: Juanita Crook, MD, 416-946-2919, juanita.crook@rmp.uhn.on.ca
RTOG 0526 has been updated as follows:
The International Prostate Symptom Index (IPSS) was replaced with the American Urological Association Symptom Index for Benign Prostatic Hyperplasia (AUA BPH) in the following sections: Index, Eligibility Checklist, Sections 3.1.5, 6.9.4, 11.1, and 12.1.
The timing of AUA BPH collection was changed in the following sections:
- Section 6.9.4; Section 11.1; Section 12.1
- Consent: Under "During the study/After the prostate seed implantation is complete…" text was added to reflect collection of AUA BPH data through year 3.
Eligibility Checklist: On page 2, question 17, the typo in the fourth bullet was corrected: "focussed" was changed to "focused".
Section 3.2.6: The typo in the fourth bullet was corrected: "focussed" was changed to "focused".
Section 10.2: For clarity, text was added regarding central review and confirmation of eligibility status.
Section 10.4.1.1: The last sentence was added for clarity.
Section 10.8: Submission of immunohistochemistry specimens, if available, was added to the Specimen Collection Summary to be consistent with Sections 10.2 and 10.4.1.1.
NOTE: This update is an editorial/administrative change to the protocol. NCI requires that this change be documented on the protocol title page with the date of the update noted as "Update Date," not as an amendment.
An updated protocol is available (no password required) on the RTOG Web site, www.rtog.org.