State-of-the-Art Lecture: What Are The Most Important Ongoing Clinical Trials In Urologic Oncology Worldwide?

Main Category: Urology / Nephrology
Also Included In: Cancer / Oncology
Article Date: 23 Jun 2008 - 0:00 PST

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ORLANDO, FL (UroToday.com) - Dr. Crawford presented information on challenges facing clinical trials from SWOG, ECOG and CALGB. Patient accrual for clinical trials is only 2-3%. Innumerable layers of rules and regulations have been created with numerous layers that increase costs and delays. He applauded prevention trials such as PCPT, SELECT, Toremifene for PIN and REDUCE. He gave poor marks for randomized treatment trials. Well designed randomized treatment trials have mostly closed secondary to poor accrual. The PUNCH study studying chemo/hormonal therapy may provide more information, but accrual is slow. The START study will randomize to treatment vs. active surveillance with delayed intervention as needed. Robotic surgery has also not been tested against existing open surgery and is sideways progress that may detract from a strong focus on clinical trials accrual, he said. He cited progress with sunitinib and sorafenib as progress of clinical trials in renal cell cancer. These drugs will be further tested in unfavorable renal cancers. In bladder cancer imaging and intravesical trials are ongoing.

Dr. Sandler presented trials from RTOG and EORTC. He focused on phase III clinical trials as central to new progress. Phase III studies must be equipoise with balance in the arms to resolve uncertainty in outcome. RTOG has completed many large randomized trials. RTOG 0126 assesses intermediate risk CaP and is accruing well. It takes about one year for a trial to ramp up to full accrual. He referred to the ProtecT study that will address screening and treatment. They will assess 5, 10 and 15 year survival. Up to 70% of localized CaP patients were randomized to active surveillance, radiotherapy or radical prostatectomy. With regard to post-operative radiotherapy, the RADICALS trial from the MRC evaluates the timing of radiotherapy. Patients are randomized to immediate or careful monitoring with salvage. The EORTC will randomize patients to post-operative radiotherapy alone or with androgen deprivation. He concluded that phase III clinical trials are critical and an international collaboration is ideal.

Presented by E. David Crawford, MD, and Howard M. Sandler, MD, at the Annual Meeting of the American Urological Association (AUA) - May 17 - 22, 2008. Orange County Convention Center - Orlando, Florida, USA.

Reported by UroToday.com Contributing Editor Christopher P. Evans, MD, FACS

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