Physicians Are Reluctant to Assign Their Patients to a Clinical Trial of a New Therapy That Might Replace the Therapy They Know and Practice

(p. D1) After learning he had early stage prostate cancer, Paul Kolnik knew he wanted that cancer destroyed immediately and with as little disruption as possible to his busy life as the New York City Ballet’s photographer.

So Mr. Kolnik, 65, chose a type of radiation treatment that is raising some eyebrows in the prostate cancer field. It is more intense than standard radiation and takes much less time — five sessions over two weeks instead of 40 sessions over about two months or 28 sessions over five to six weeks.

. . .

The National Cancer Institute has just agreed to fund a clinical trial that researchers hope will settle which treatment is better. It will randomly assign 538 men to have either a short course of five intense radiation sessions over two weeks or 28 treatments over five and a half weeks, comparing outcomes for quality of life as well as disease-free survival.

But it will be at least eight years before the answers are in. In the meantime, men and their doctors are left with uncertainty.

“Ideally, we want to show five treatments (p. D4) is better,” said Dr. Rodney J. Ellis, a radiation oncologist at Case Comprehensive Cancer Center in Cleveland and the principal investigator for the trial.

One reason for the dearth of data is that prostate cancer usually grows slowly, if at all, so it can take many years to see if a treatment saved lives. It is expensive and difficult to follow patients for such a long time, and the treatments given to the men often change over a decade, making doctors wonder if the results are relevant.

Also, researchers who have tried to conduct studies comparing treatments often failed because specialists were already convinced that the method they used was best and were reluctant to assign men to other treatments. Dr. Ian Thompson of the University of Texas Health Science Center in San Antonio, said he was involved with several clinical trials that withered for that reason.

. . .

The researchers on the new study think recruitment will not be a major problem because they are comparing different courses of radiation, rather than entirely different approaches — for example, surgical removal of the prostate versus implantation of radioactive seeds in the prostate. A study to investigate those two approaches closed because investigators were able to enroll only 20 patients, Dr. Thompson said.

. . .

A few years ago, Dr. Yu and his colleagues looked at Medicare data and reported that men who had more intense radiation therapy were more likely to have urinary problems after two years than those who had the longer-course therapy.

Dr. Yu noted that his study was not a randomized trial, the gold standard, but he said the results were not reassuring. Now, though, he is not so sure the intense therapy is worse.

“In my own experience, these men have done really well,” he said. “That tells us that techniques improved, or the medical claims we evaluated were not indicative of major toxicity, or the way we and others at high-volume centers deliver radiotherapy is different.”

The lack of solid data bothers Dr. Daniel W. Lin, chief of urologic oncology at the University of Washington. When men ask him about the shorter radiation course, he tells them, “It probably can work but it doesn’t have long-term results and it hasn’t been tested against standard radiation.”

At centers like Sloan Kettering, doctors are relying on their own experience.

Dr. Michael J. Zelefsky, a radiation oncologist who treated Mr. Kolnik there, said that several years ago, 90 percent of his patients had the standard course of treatment. Now 90 percent choose the shorter course. On the basis of Sloan Kettering’s experience with several hundred men who had the intense radiation therapy over the past three years, the treatment, he said, “is emerging as a very exciting form of therapy.”

For the full story see:

Gina Kolata. “Unproven Therapy Gains Ground.” The New York Times (Tuesday, March 21, 2017 [sic]): D1 & D4.

(Note: ellipses added.)

(Note: the online version of the story has the date March 20, 2017 [sic], and has the title “Popular Prostate Cancer Therapy Is Short, Intense and Unproven.”)

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