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North Shore-LIJ Using FDA-Cleared Prostate Test

May 2, 2013

Photo credit Newsday Alejandra Villa

Newsday
May 3, 2013
New Prostate Tumor Technology Called Equivalent of GPS
By DELTHIA RICKS  

Dr. Art Rastinehad, director of Interventional Urologic Oncology at LIJ Medical Center, talks about new FDA approved prostate imaging technology known as Fusion-Guided Biopsy. (May 2, 2013)
The lead investigator of an evolving way to obtain images of prostate tumors and accurately diagnose them said the new technology is the medical equivalent of a global positioning system -- GPS -- for the prostate gland.

North Shore-LIJ is the only institution outside the National Institutes of Health in Bethesda, Md., to use the new diagnostic system, Dr. Art Rastinehad, of North Shore-Long Island Jewish Health System, said Thursday at a news conference.

Current biopsy testing relies on decades-old technology, which misses a vast number of cancers and delays treatment for many men, Rastinehad said. "Biopsies have been performed the same way for the last 30 years," said Rastinehad, who noted the current technique involves a needle biopsy and ultrasound imaging. If the cancer grows outside what can be seen on an ultrasound, the tumor can be missed, he said, adding that standard technology evaluates less than half a percent of the prostate gland.

He and his collaborators at the NIH have been testing a new system that they helped to develop. It's loosely called a fusion biopsy, he said, because it involves both MRI and ultrasound imaging.
Additionally, Rastinehad said, a so-called field generator, similar to a GPS device, is placed over a patient's hip to guide the entire biopsy process. The MRI and ultrasound images, meanwhile, are overlaid in real-time, providing a more comprehensive, multidimensional view of the gland. "Our goal is to have a more image-based standard of care for biopsying prostate cancer, but we are still building a body of evidence," he said.

Developed by Invivo, a unit of Philips Healthcare, the system is formally called UroNav. Rastinehad and his NIH colleagues have tested it on more than 900 men and think it provides multiple advantages over the current standard. The Food and Drug Administration approved the system for widespread use last month. More than 240,000 new cases of prostate cancer are diagnosed annually nationwide. About 30,000 men die of the disease.

Rich Bolton, 61, a retired financial executive, underwent a biopsy with the system in January as part of Rastinehad's research.

Bolton, who lives in Point Lookout, said he had routine screenings for prostate cancer involving the prostate-specific antigen blood test -- the PSA -- which on more than one occasion showed a high reading. "I had been watching my PSA numbers starting back in December of 2007," he said. "The numbers started to rise and I got a prostate biopsy and it came back negative.

"My PSA rose again in 2009," Bolton said. "I have a family member who is a urological surgeon in Kentucky and he was a bit concerned but made sure I stayed on top of it."

Bolton got a second biopsy -- but that also came back negative.

His doctor put him on Proscar, a drug that could address a high PSA not due to cancer. But as time passed, the PSA remained high, which prompted his Garden City physician to recommend Rastinehad, whose research into precision imaging was gaining notoriety on Long Island.
Bolton's fusion biopsy revealed an advanced cancer. "Dr. Rastinehad's instruments have GPS in them so he found the cancer," he said. "I am stage 4, but I probably wouldn't have known this for another couple of years."

"I had a full body scan and the cancer is really isolated," Bolton said. "They caught it late, but they caught it while it is treatable."

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North Shore-LIJ TV
May 3, 2013
Fusion-Guided Biopsy Improves Prostate Cancer Detection

Watch this Story
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Long Island Business News
May 2, 2013
North Shore-LIJ Using FDA-Cleared Prostate Test
by Claude Solnik

The North Shore-Long Island Jewish Health System is participating in a clinical trial of advanced imaging software to detect prostate cancer.

The software, known as image fusion, helps better target possible prostate cancer for biopsies, a big change from random biopsies based on prostate specific antigen levels.

The Food and Drug Administration a few weeks ago cleared the URoNav Fusion Biopsy System, developed by Philips Healthcare, along with the National Institutes of Health.

Philips is the second company to use what’s known as image fusion to detect prostate cancer. Eigen’s Artemis already has been approved.

The new technologies mark a potential breakthrough in prostate cancer detection, which has long perplexed physicians and fueled a debate over when, how and even whether to treat.

UroNav clinical trials detected prostate cancer in nearly 40 percent of patients with high PSAs where traditional biopsies found nothing.

Fusion technology tests done on Richard Bolton, a 61-year-old Point Lookout resident, detected cancer, after two standard biopsies did not.

“I was fortunate to be part of the study and the new technology was available in New York,” Bolton said, adding the cancer was caught before it spread.

“Prostate cancer is the only cancer we diagnose from an indirect method,” said Dr Art Rastinehad, North Shore-LIJ’s director of interventional urologic oncology. “Then we randomly sample the gland without imaging except the ultrasound for guidance.”

In addition to ultrasounds, physicians are beginning to use MRIs to better detect prostate cancer.
But in the newest approach, the MRI and ultrasound image are laid over each other to create three dimensional images that let doctors take biopsies in problem areas.

“Biopsies have been performed the same way using the ultrasound as guides since 1980s,” Rastinehad said. “This allows us to see inside the prostate.”

Doctors today typically do six to 12 random biopsies in the prostate after patients exhibit a high PSA.
The UroNav uses MRI ultrasound fusion to do biopsies in areas that show possible signs of cancer.
The new technology allows fewer, more targeted biopsies, which also could reduce side effects from biopsies, such as infection, bleeding and even death.

In addition to North Shore-LIJ, UCLA has begun using the device in a study.

“The goal is to change the way we screen men for prostate cancer by using an image-based approach to prevent unneeded biopsies and missing cancer,” Rastinehad said.

 

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