Table 2.

PCPT Biopsy Adherence Activities

Strategy	Description
Biopsy Video: Your Prostate Biopsy: The Final Piece of the Puzzle	The PCPT Study Coordinator (IMT) introduced video, emphasizing how procedures will differ by PCPT site; a PCPT Urologist performed two for cause biopsies on patients (not study participants). The Study Coordinator describes the surgery as it is being performed (three components: digital rectal examination, probe and ultrasound, and the biopsy); explains what happens to the patient’s prostate tissue samples; describes what the patient should do after the biopsy (e.g., take prescribed antibiotic); two study participants comment on for cause biopsies they have experienced during the trial and the importance of the biopsy information for the trial.
Focus Group Project	Four groups held (San Antonio, TX and Winston-Salem, NC Showed video Identified participant barriers to complying with the endpoint biopsy Suggestions: Show video as soon as possible Consider group educational sessions Provide additional information re: potential interactions of vitamins, herbs, & medications re: biopsy procedure Plan for dissemination of information re: study findings and next-steps for participants post-biopsy
Participant Feedback Post Viewing of Video	A list was posted at each PCPT site for participants to note comments about the prostate biopsy video.
Site Grants	Available for holding sessions to show the Biopsy Video, for Q&A sessions about the biopsy with study urologist.
Study Site Staff Meetings and Workshops	Reinforced the importance of the biopsy requirement and suggested strategies for preparing study participants (End of Study Biopsy Packet was distributed). Throughout the trial, site staff received current information on the progress of the study through the PCPT Newsletter, The PCPT update.
End-of-Study Biopsy Manual	This Manual was designed to help study staff educate study participants and site urologists about the importance of the end-of-study biopsy. It addressed the following planning issues: logistics (e.g., communicating with site urologists); holding a biopsy information session; biopsy information for study participants (e.g., the brochure); pathology issues; plans for after the biopsy; payment information for the biopsy; information on the site grant program; and tips for finding participants lost to follow-up. Site staff were encouraged to customize the folder to make it useful for the specific site but time tables and strategies were suggested.
Articles in the PCPT Participant (The Vanguard) & Staff Newsletters (PCPT update)	Thoughts for the Undecided PCPT Participant (The Vanguard) Will End-of-Study Biopsies Tell the Whole Story? (PCPT update)
Endpoint Biopsy Brochure, Information Sheets	Your Prostate Biopsy: The Final Piece of the Puzzle Brochure allowed participants to have information about the end-of-study biopsy that they could take with them and share with family members and medical providers: how to prepare for the procedure; the three steps involved in the biopsy; what to expect after the biopsy; follow-up with physicians; receiving the biopsy results..
Pilot Study at 1 Site	Held endpoint biopsy informational sessions for participants with study urologist and CRAs. Successful and not so successful strategies used in this pilot study were summarize for use in training workshops for all PCPT site staff. A Procedural Manual based on the pilot study was distributed to site staff.
Adherence Coordinator at Coordinating Center	This person (SH) supported a comprehensive set of adherence activities that included the endpoint biopsy requirement.