New Diagnostic Tools for Prostate Cancer

“Dan Woska was weighing his treatment options after he was found to have prostate cancer two years ago when a friend mentioned a new genomic test that could gauge how lethal his tumor was.

“The test, called Oncotype DX, which looks at the expression of 17 genes in a tumor, cost about $4,000 and was not covered by Mr. Woska’s insurance. But through a patient assistance program, the company that created it, Genomic Health, ran it for him free, using a tiny grain of tissue left over from his biopsy. The results indicated there was an 81 percent probability that Mr. Woska’s tumor would not spread beyond the prostate. On an aggressiveness scale of zero to 100, the tumor was an indolent 15.

“Thrilled and relieved, Mr. Woska decided to forgo radiation and surgery.”

Multigene Assay Validated for Risk Assessment in Prostate Cancer

“There has been a preponderance in the healthcare industry to overtreat early-stage, slow-progressing prostate cancer, often subjecting patients to unwarranted, life-altering treatments. According to Genomic Health Inc, provider of genomic-based diagnostic tests, increased surveillance should be the primary outcome in patients with clinically localized prostate cancer (PC). To prevent overtreatment in such patients, they have developed the Oncotype DX test that allows clinical risk assessment for differentiating between high-risk and low-risk patients with prostate cancer (PC).

“Oncotype DX prostate cancer assay is a multigene RT-PCR expression assay compatible with fixed paraffin-embedded diagnostic prostate needle biopsies. The assay measures expression of 12 cancer-related genes (AZGP1, KLK2, SRD5A2, FAM13c, FLNC, GSN, TPM2, GSTM2, TPX2, BGN, COL1A1, and SFRP4) and five reference genes that are algorithmically combined to calculate the Genomic Prostate Score (GPS) ranging from 0 (low) to 100 (high). This 17-gene biopsy-based assay has been analytically and subsequently validated as a predictor of aggressive PC.”

UCSF-led Study Shows Oncotype DX and MRI May Provide Independent Information in Favorable Risk Prostate Cancer

“Genomic Health, Inc. (Nasdaq: GHDX) today announced results from a study led by the University of California, San Francisco (UCSF) showing a broad distribution of Oncotype DX® Genomic Prostate Score (GPS) results among prostate MRI findings, suggesting that these two technologies may provide non-overlapping clinical information in men with localized prostate cancer.

” ‘For the first time, we looked at the association between information provided by a genomic assay and a prostate MRI to better understand the value these two technologies bring to clinical practice,’ said Michael Leapman, M.D., lead investigator from UCSF. ‘These new data show that, in some patients, further risk stratification may be possible, and tools such as GPS may add important biological information to more precisely assess the aggressiveness of a patient’s cancer.’

“In this study, researchers conducted a retrospective evaluation of the statistical association between the Oncotype DX GPS results and contributing gene groups with baseline endorectal MRI in 100 patients with clinically localized prostate cancer. The results showed a large variation of GPS results across MRI findings, demonstrating that Oncotype DX and MRI offer non-overlapping clinical insights in patients with early-stage prostate cancer.”

New Discovery Could Uncover 'Missing Link' in Genetics

“Researchers believe that susceptibility to common diseases stems from a combination of common genetic variants and a variety of rare genetic mutations. But this only accounts for a small proportion of potential heritable risk factors for disease. Now, new research has discovered that some genetic variants could indicate the presence of rare genetic mutations that have yet to be discovered, which may contribute to the risk of common diseases.”

Editor’s Note: While this story is about genetics as it relates to cancer risk, genetics can also provide valuable information to guide treatment. Interested readers might look into the following tests, which are just a few of several molecular/genetic tests to guide prostate cancer treatment: Oncotype DX, Prolaris, and PCA3.

Human Psychology May Lead to Overtreatment of Prostate Cancer

Peter Ubel, author of the book Critical Decisions, discusses the potential impact of Oncotype DX, a new prostate cancer test, on treatment decisions. The test, which has not yet gone through a rigorous peer review process, may help identify low-risk tumors that do not need aggressive treatment. Ubel analyzes the role of human psychology on cancer treatment decisions and feels that such a test may not be accepted by patients as a reason to forego curative treatment.

New Genetic Test May Improve Diagnostic Accuracy for Prostate Cancer

Genomic Health is releasing a new genetic test called the Oncotype DX prostate cancer test. The test analyzes the activity of 17 genes in tissue from prostate biopsies to calculate the cancer’s level of aggressiveness. In a clinical study, the test distinguished low-risk from high-risk prostate cancer more accurately than the current method of analyzing prostate cancer tissue under a microscope. Results of the study were presented at the annual meeting of the American Urological Association.