Clinical trial accrual rates in prostate cancer: Prospective experience from a single institution

Abstract

15611 Background: Clinical trial (CT) participation is a key to better cancer therapy. The Nevada Cancer Institute (NVCI), the official cancer center of NV, is committed to CT participation. We hypothesized that CT accrual at the NVCI should exceed the national average of 3–5%. Methods: Patient (pt) visits began in 3/05 and by 12/31/07 1363 pts had been seen. Prostate cancer (PC) was the largest group (N=270; 50 with 1 visit only). All records are electronic and entered into a cancer registry. A relatively robust portfolio of PC CTs has been available, thus the cancer registry data base was compared to the CT data base for the 16 PC CTs (8 phase III, 1 phase II, 7 phase I) that accrued pts. The data base records all accruals, screen failures, consent withdrawals, and subsequent treatments (on or off CT). Results: 101 consents were signed by 68 PC pts (25 consented to 2 or more CTs). 31 consents lead to screen failures/consent withdrawal (5 pts were screen failures for 2 CTs while 1 pt was a screen failure for 3 CTs). Screen failure was less common in phase II/III CTs (18/74 =24%) than in phase I CTs (10/27=37%). Most of the phase I screen failures were due to rapid decreases in performance status or organ function dysfunction. Among the 68 unique pts who consented, 35 pts were treated on 1 CT and 16 pts were treated on 2 or more CTs resulting in a total of 51 PC pts being treated on at least 1 CT. Conclusions: CT accrual at the NVCI of PC pts (51/270=19%) exceeds the national average. Reports of CT activity should specify the denominator and include both consent and accrual rates. Screen failure/consent withdrawal was common in this older male population with advanced disease. This analysis has limitations; Phase I CTs were activated only after 10/05, only 1 phase II CT was open during this period and CTs for radiation and surgery alone for PC pts were not open. Thus, the percent of pts on CT should rise as more CTs are activated. No significant financial relationships to disclose.