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Tumor Aggressiveness Assay for Prostate Cancer
TDI's Isonostics™ assay development program in prostate cancer is targeted to select the 2-16% of those patients that actually need more aggressive treatment options out of the 93% who currently receive such treatment.
The aggressive treatment that currently dominates prostate cancer care can bring significant negative implications for the patient’s quality of life. There is a 0.5% mortality rate associated with radical prostatectomy.1 Urinary incontinence and sexual potency loss caused by nerve damage during radical prostatectomy average 18.5% and 50%, respectively.2 With external beam radiation, patients need to be irradiated 5 days a week for 6-8 weeks, which is a major inconvenience. Patients that choose brachytherapy (implantation of radioactive “seeds” into their prostate tumors) can suffer significant rectal problems as a result of adjacent effects from the localized radiation, and the cancer recurs in 22% of brachytherapy patients,3 for which no salvage therapy is possible. Furthermore, the current aggressive treatment practice for prostate cancer places an estimated annual burden of $0.9-2.3B on the US heathcare system.
Prostate is one of the most diagnosed cancers in the US with 189,000 diagnosed cases in 20044 and 232,000 cases in 2005.5 Prostate cancer is generally a slow growing cancer, for which onset is associated primarily with age (less than 1.1% of men under 55 are diagnosed).6 Five-year survival for men diagnosed with early stage prostate cancer is near 100%. Ten year survival for all patients regardless of staging is 92%. Fifteen year survival for all patients is 61%.7 The reason for this high rate of survival is that prostate cancer usually takes an indolent course: in other words, most patients tend to die WITH prostate cancer, not FROM prostate cancer. Less than 16% of prostate cancer patients will die from prostate cancer, and some estimates place the chances as low as 2-3%.8 Yet, the majority (93%)9 of prostate cancer patients are still aggressively treated, on the off chance that they have a more aggressive form of the disease. Other clinical data further suggests that only 6.3% of these patients actually benefit from this treatment.10
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1Mark, DH. J Urol., 152:896-8, (1994).
2Lefevre, M., American Family Physician, 58:2, August 1998.
3Ragde, Cancer, 83(5): 989, 1998.
4American Cancer Society, “Cancer Facts and Figures,” (2004).
5American Cancer Society, “Cancer Facts and Figures,” (2005).
6Surveillance, Epidemiology, and End Results (SEER) Program public use D-ROM (1973-94), National Cancer Institute, DCPC, Surveillance Program, Cancer Statistics Branch. Released May 1997, based on August 1996 submission.
7Lu-Yao and Yao. Population-based study of long-term survival in patients with clinically localized prostate cancer. Lancet, 349:907, (1997).
8Silverberg and Lubera, Cancer J. Clin., 36:9 (1986).
9Yan et al., Cancer, 88:1454-1463 (2000).
10Fireman et al., Health Care Finance Rev., 18:51 (1997).
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