Guidelines suggest that the optimal management of patients with castration-resistant prostate cancer (CRPC) — also known as hormone-refractory prostate cancer or HRPC — is participation in a randomized clinical trial. But encouraging community-based clinicians to enroll their patients in clinical trials has long been problematic.
Chao et al. have just published an interesting paper demonstrating that perhaps only 50 percent of patients with CRPC seen by community-based physicians are actually eligible for treatment in randomized clinical trials at all.
The inclusion criteria for randomized clinical trials are usually relatively stringent. The authors reviewed eligibility criteria from 24 Phase III clinical trials evaluating chemotherapy for CRPC that were enrolling patients or fully enrolled but ongoing between January 2004 and April 2008. They created a common list of criteria used in at least 3 studies and separately considered the criteria from a very prominent Phase III trial (the TAX327 trial that demonstrated the effectiveness and safety of docetaxel as a treatment for CRPC). They then applied these criteria to a population of patients with CRPC treated between 2004 and 2006 at the Veterans Affairs Connecticut Healthcare System.
Among 106 patients with CRPC under treatment at the VA system, 99 (93 percent) had complete medical records, and 45/99 (45 percent) would have been excluded from randomized clinical trials based on their medicalonditions. Common reasons for exclusion were abnormal laboratory values, other malignancies, and other serious conditions such as cardiac disease.
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment, Uncategorized Tagged: | clinical trials, CRPC, eligibility
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They want a healthy, vigorous person … who is dying of cancer. Small group, that!