UroToday - AUA 2008 - State-of-the-Art Lecture: What are the Most Important Ongoing Clinical Trials in Urologic Oncology Worldwide?

[Guest guest]

" Patient accrual for clinical trials is only 2-3%. Well designed randomized

treatment trials have mostly closed secondary to poor accrual. " This means

they are having trouble getting men to participate in the trials. Unless men

are willing to participate we will be wasting research money and not get

answers. Any ideas about what can be done or what the problems are?

Kathy

Wednesday, 21 May 2008

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. Crawford, MD, and M. Sandler, MD, at the Annual

Meeting of the American Urological Association (AUA) - May 17 - 22, 2008.

Orange County Convention Center - Orlando, Florida, USA.

http://tinyurl.com/3ejkpj

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