Myriad's Prolaris® Test Guides Treatment Decisions for Men with Prostate Cancer
In addition to compelling data on the clinical utility of Prolaris in changing treatment plans for men with prostate cancer, the Company will present data from two new clinical studies on the Prolaris test. These studies further demonstrate the ability of the Prolaris test to accurately stratify a prostate cancer patient's risk of having an aggressive form of the disease. Prolaris has now been validated in 11 clinical studies in approximately 5,000 patients with prostate cancer. Another new study in renal cell carcinoma also will be presented at the SUO meeting, demonstrating that Myriad's cell cycle progression gene panel predicts metastatic progression in patients with this deadly cancer.
"A major challenge for physicians treating men with prostate cancer is knowing whether a prostatectomy or other type of treatment is necessary, or if active surveillance is appropriate," said
Clinical Utility of Cell Cycle Progression Genes in Facilitating Prostate Cancer Treatment Decisions. [Shore et al., Poster Session II:
The prostate biopsy research study evaluated Prolaris' potential clinical utility in guiding the treatment decision for patients diagnosed with prostate cancer. Participating physicians were asked to assess the value of the Prolaris score and questionnaires were completed for 294 evaluable patients with localized prostate cancer. Physicians indicated that 55 percent of tests generated a mortality risk score that was either higher or lower than what they expected. Physicians also indicated that 32 percent of test results would lead to a definite or possible change in treatment plan, with the net effect of shifting patients from more aggressive to more conservative treatment. These data strongly suggest that the Prolaris test can help physicians determine the aggressiveness of prostate cancer and tailor treatment plans for individual patients. A second large prospective clinical utility
study called PROCEDE 500 also is underway. An interim analysis of that study showed that physicians would change actual treatment selection in 65 percent of cases after they reviewed the results of the Prolaris test with their patients. Data from PROCEDE 500 will be presented at the ASCO Genitourinary Cancers Symposium in
Prolaris CCP Score Stratifies Risk for Prostate Cancer Patients at Biopsy: Initial Commercial Results. [Crawford et al., Poster Session II:
This study focused on the Prolaris test's accuracy in predicting the aggressiveness of prostate cancer based on analyses of biopsy samples. A total of 1,604 patient samples were included for analysis. The study found that Prolaris improved risk stratification for men with prostate cancer independent of the Gleason score and PSA level. Specifically, the results showed that 27.9 percent of men had a less aggressive cancer compared to the standard pathologic prediction and were assigned to a lower risk group, while 27.6 percent had a more aggressive cancer. More than 50 percent of men initially tested in the commercial assay were assigned to a different risk category than predicted by their standard pathologic features alone. These findings underscore the prognostic utility of Prolaris in a commercial setting.
Prognostic Utility of the Cell Cycle Progression Score Generated from Needle Biopsy in Men Treated with Prostatectomy. [Bishoff et al., Poster Session I:
This study demonstrates the ability of the Prolaris test in predicting cancer progression, as measured by both biochemical recurrence and metastatic disease after radical prostatectomy. The study found that the Prolaris test was a strong predictor of biochemical recurrence and was the strongest predictor of metastatic disease. High risk patients had over a six-fold higher risk of developing metastases compared to low risk patients. These results indicated that the Prolaris test can be used at the time of disease diagnosis to better define patient prognosis and help select the appropriate clinical care.
Cell Cycle Progression Score Predicts Metastatic Progression of Clear Cell Renal Carcinoma After Resection. [Poster Session I:
This study evaluated the prognostic value of a cell cycle progression test on patients with renal cell carcinoma. Twenty-six patients and 38 controls were evaluated. The analysis revealed that the spread of a cancer to the blood vessels and lymph nodes, tumor grade and cell cycle progression score were the only independent variables that significantly predicted progression to metastasis. A combined analysis of age, cell cycle progression, tumor size and the spread of a cancer to the blood vessels and lymph nodes revealed an area under the curve of 0.84 that decreased to 0.78 if the cell cycle progression score was excluded. These findings indicate that the cell cycle progression score predicts metastatic progression after resection of organ-confined, clear-cell renal cell carcinoma and appears to add prognostic information to standard clinical and pathologic variables. These findings warrant further investigation.
Prolaris is a novel prognostic test developed by
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