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Hospital release makes unjustified leap from low toxicity found in safety trial to pronounce a “cure”

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IMAGE: Dr. Raquibul Hannan is pictured. view more

Credit: UT Southwestern Medical Center

DALLAS – April 18, 2016 – A five-year study shows that Stereotactic Body Radiation Therapy (SBRT) to treat prostate cancer offers a higher cure rate than more traditional approaches, according to researchers at UT Southwestern Medical Center Harold C. Simmons Comprehensive Cancer Center.

The study – the first trial to publish five-year results from SBRT treatment for prostate cancer – found a 98.6 percent cure rate with SBRT, a noninvasive form of radiation treatment that involves high-dose radiation beams entering the body through various angles and intersecting at the desired target. It is a state-of-the-art technology that allows for a concentrated dose to reach the tumor while limiting the radiation dose to surrounding healthy tissue.

“The high cure rate is striking when compared to the reported five-year cure rates from other approaches like surgery or conventional radiation, which range between 80 to 90 percent, while the side effects of this treatment are comparable to other types of treatment,” said Dr. Raquibul Hannan, Assistant Professor of Radiation Oncology and lead author for the study. “What we now have is a more potent and effective form of completely noninvasive treatment for prostate cancer, conveniently completed in five treatments.”

Conventional treatment options for early stage prostate cancer include:

  • Prostatectomy, the surgical removal of the prostate gland, which can be done with minimally invasive techniques and robotic assistance;
  • Brachytherapy, in which doctors implant numerous small radioactive seeds about the size of a grain of rice into the prostate gland using multiple large needles inserted through the skin in the operating room. Once implanted, the seeds release their radioactivity directly into the prostate gland; and
  • External beam radiation, which involves 42 to 45 treatments administered over two or more months, five days a week.

“The current form of radiation is 44 treatments given over nine weeks. In contrast, the SBRT therapy we used allows the delivery of highly focused radiation in only five treatments, allowing patients to return to their normal lives more quickly,” said senior author Dr. Robert Timmerman, Director of the Annette Simmons Stereotactic Treatment Center at UT Southwestern, and Professor and Vice Chairman of the Department of Radiation Oncology. “SBRT is both more convenient and has increased potency.”

UT Southwestern served as the lead site for the multi-institutional clinical trial, which involved first-time prostate cancer patients diagnosed with stage I or stage II (low and intermediate risk) prostate cancer. A total of 91 patients were treated prospectively and followed for five years, with only one patient experiencing a recurrence of his cancer. The findings are published in the European Journal of Cancer.

Terry Martin of McKinney, Texas, – about an hour outside Dallas – said the fewer number of treatments was a compelling advantage when he was evaluating treatment options.

“I live 45 minutes away from UT Southwestern. The difference between being treated five times versus 44 times is enormous,” said Mr. Martin, a retired airline pilot. “I felt that I was back to normal just 10 days after finishing treatment.”

In addition to shorter treatment times, researchers found that side effects were not necessarily different compared to other forms of prostate cancer treatment. In the short term, the side effects of SBRT can include urinary issues (urgency, frequency and burning) and rectal irritation, which are often temporary and reverse within four weeks of treatment. Researchers found a small risk of longer-term urinary and rectal complications, which is also comparable to conventional treatments. Decrease in erectile function was seen in 25 percent of patients, fewer than with conventional radiation or surgery, said Dr. Hannan.

To reduce the side effects associated with SBRT, current clinical trials at UTSW are using a unique and biodegradable rectal spacer gel to protect the rectum. UTSW is currently the only accredited site in Texas at which this spacer gel can be used.

Other clinical trials at the UTSW Department of Radiation Oncology are seeking to expand the application of SBRT to high-risk (Stage III) prostate cancer patients. “Our hope is that the high potency of this form of treatment will significantly improve treatment of these patients,” says Dr. Hannan, the principal investigator of the high-risk prostate SBRT trial.

UT Southwestern has been a leader in pioneering use of SBRT. Dr. Timmerman, Director of Image-Guided Stereotactic Radiation Therapy, Medical Director of Radiation Oncology, and holder of the Effie Marie Cain Distinguished Chair in Cancer Therapy Research, has served as the lead investigator in several national trials designed to evaluate the efficacy and safety of SBRT to treat other types of cancer, including cancer in the lung, liver, and spine. A range of clinical trials of SBRT therapy are under way at Simmons Cancer Center, including new investigations evaluating use of SBRT for cancers in the breast and larynx.

Since 2009, UT Southwestern has trained more than 300 physicians and peers interested in implementing SBRT in their clinical practice. Simmons Cancer Center’s arsenal of stereotactic radiotherapy technology includes the cutting-edge Gamma Knife, CyberKnife, Agility, Vero SBRT and TrueBeam technologies.

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The SBRT study for prostate cancer was supported by a grant from the U.S. Department of Defense. Additional UTSW researchers involved in the study include Dr. Yair Lotan, Professor of Urology and holder of the Helen J. and Robert S. Strauss Professorship in Urology, and Dr. Xian-Jin Xie, Professor of Clinical Science.

The Harold C. Simmons Comprehensive Cancer Center is the only NCI-designated Comprehensive Cancer Center in North Texas and one of just 45 NCI-designated Comprehensive Cancer Centers in the nation. The Simmons Cancer Center includes 13 major cancer care programs with a focus on treating the whole patient with innovative treatments, while fostering groundbreaking basic research that has the potential to improve patient care and prevention of cancer worldwide. In addition, the Center’s education and training programs support and develop the next generation of cancer researchers and clinicians.

The Simmons Cancer Center is among only 30 U.S. cancer research centers and the only cancer center in North Texas to be named a National Clinical Trials Network Lead Academic Participating Site, a prestigious designation by the NCI, designed to bolster clinical cancer research for adults and to provide patients access to cancer research trials sponsored by the NCI, where promising new drugs often are tested.

About UT Southwestern Medical Center

UT Southwestern, one of the premier academic medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty has included six who have been awarded Nobel Prizes since 1985. The faculty of almost 2,800 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide medical care in about 80 specialties to more than 92,000 hospitalized patients and oversee approximately 2.2 million outpatient visits a year.

This news release is available on our home page at http://www.utsouthwestern.edu/home/news/index.html

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UT Southwestern research shows 98 percent cure rate for prostate cancer using SBRT

Our Review Summary

prostate cancerThis news release draws from a Phasel/ll safety study of 91 patients who were given a concentrated form of higher-dose radiation known as stereotactic body radiation therapy, or SBRT, instead of typical radiation therapy for early-stage prostate cancer. The study was designed to test the toxicity of increasing levels of radiation, not to assess the survival rate.  While the five-year study showed benefits, the release failed to provide the numbers and details that we believe would help readers understand the risks vs. benefits. The “cure” rate referred just to men who had no evidence of rising prostate-specific antigen (PSA) — and the study acknowledges that most men were not actually followed for 5 years so a “cure rate” was statistically estimated. However, over a third of the men had low-risk cancer where the 5-year cancer-specific survival is estimated to be 100 percent. It’s not certain that these men actually required treatment.

 

Why This Matters

The National Cancer Institute estimates there will be about 180,890 new cases of prostate cancer diagnosed in the United States this year. Some of them will be treated with active surveillance, the “watch and wait” treatment. More aggressive cancers may require surgery, radiation or chemotherapy. Among those treated with radiation, stereotactic radiotherapy (SBRT), an alternative form of radiation therapy described in this release, may offer a shorter course of treatment (five sessions) compared to external beam radiation therapy which is typically delivered over the course of about six weeks. The shorter SBRT approach suggests an important convenience benefit to patients. Treatment toxicity with this procedure was also low, according to the release, although there was no control group in the study to compare it with.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The release does not discuss costs. We find this disappointing, but also ironic. In a very quick search, we discovered that one of the major topics regarding SBRT is its low-cost relative to the existing therapies. In the Journal of Oncology Practice, authors in 2012 directly compared it cost-wise to another method and concluded: “SBRT for low- to intermediate-risk prostate cancer has great potential cost savings for our health care system payers and may improve access to radiation, increase patient convenience, and boost quality of life for patients.”

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

This is an odd news release. The study, described as a Phasel/ll, was conducted to assess the safety of escalating doses of radiation with the goal of determining whether varying doses of SBRT had an acceptably low rate of toxicities. The study was not intended to provide any definitive assessment of survival benefit, and yet that’s what the release is about.  It states:

“The study — the first trial to publish five-year results from SBRT treatment for prostate cancer — found a 98.6 percent cure rate with SBRT, a noninvasive form of radiation treatment that involves high-dose radiation beams entering the body through various angles and intersecting at the desired target.”

The “cure” rate referred just to men who had no evidence of rising PSA — and the study acknowledges that most men were not actually followed for 5 years so “cure rate” was statistically estimated.  However, over a third of the men had low-risk cancer where the 5-year cancer-specific survival is estimated to be 100 percent. It’s not certain that these men actually required treatment.

Beyond that, the release did not quantify benefits precisely. There was only one sentence directly addressing the study results. There was no description precise study group demographics. The release does not define “cure” as it is used in the sentence below and the headline.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The release does include a paragraph about urinary side effects (among others) for patients in the trial. But the release deliberately seems to try to minimize these. (Editor added italics.)

“In addition to shorter treatment times, researchers found that side effects were not necessarily different compared to other forms of prostate cancer treatment. In the short term, the side effects of SBRT can include urinary issues (urgency, frequency and burning) and rectal irritation, which are often temporary and reverse within four weeks of treatment. Researchers found a small risk of longer-term urinary and rectal complications, which is also comparable to conventional treatments. Decrease in erectile function was seen in 25 percent of patients, fewer than with conventional radiation or surgery, said Dr. Hannan.”

Many men might find a one-in-four chance of impotence a high price to pay for treatment for early-stage prostate disease. We have to complain that the release does not give us numbers for the harms — in any way that is meaningful and allows us to compare this new therapy to existing therapies.

The phrase “not necessarily different” is not helpful. The phrase “a small risk” is not giving us a number we can use.

As noted above, a substantial proportion of the patients might not have needed treatment — so that even a “small risk” of complications would be unacceptable. In the absence of a comparison group, no conclusions can be drawn as to whether this represents a less harmful active treatment option.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

This was basically an observational cohort study which was powered to accurately determine the proportion of men who would suffer radiation toxicity. The study was not designed to determine whether this treatment was more effective than other radiation modalities or surgery. We did not find the sort of descriptions of the study protocols that we expect from a release. The study — which we took the time to read — appears of good quality but the release did not tell us that. The study was limited to 91 patients, which isn’t a very big study.

Does the news release commit disease-mongering?

Satisfactory

There is no disease mongering.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The release provides the funding source (the U.S. Department of Defense) although it does not explicitly comment on the absence of conflict.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The release gives us some information about this treatment vs. traditional radiation and lists other important alternatives including prostatectomy (surgical removal of the prostate gland), brachytherapy (the implantation of small radioactive seeds), and external beam radiation. One alternative not mentioned — which is appropriate for low-risk cancers — is active surveillance (monitoring the patient and deferring active treatment).

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The news release hints that SBRT is available at the study location but does not provide readers with any other indication about its availability in other regions. We do know that SBRT is widely available at other academic medical centers and has been in use for more than a decade. It is also sometimes marketed as the “CyberKnife” at private medical facilities.

Does the news release establish the true novelty of the approach?

Satisfactory

The release claims that the study was the first published trial to follow patients receiving SBRT for five years.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

We question the use of “cure” in the headline. And, while the current report did focus on “freedom from biochemical failure (i.e., no increase in PSA)” — which is not the same as cure — the primary intention of the study was to assess toxicity.  Talking about a “strikingly” high cure rate is misleading given the absence of a control group.

Total Score: 4 of 10 Satisfactory

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