Prostate Cancer

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Prostate Cancer Diagnosis

Prostate cancer is the most frequent cancer in men, with more than 209,000 new cases estimated for 2008 in the United States and Canada. The current standard screening method is carried out by measuring the level of prostate specific antigen (PSA) in the blood, combined with a digital rectal examination. An estimated 45 million PSA tests will be carried out this year worldwide; this number is expected to increase with the official implementation in the United States of a routine prostate cancer screening program for men over age 50, which represents 35 million Americans. However, the sensitivity of the PSA test is being seriously questioned by the scientific community, and its specificity of 27%[1] requires significant improvement. This low specificity results in a high number of false positives, which generate numerous unnecessary and expensive biopsies.

The earlier prostate cancer is detected (i.e. when confined to the prostate gland), the greater are the chances of successful treatment. According to the American Cancer Society, ninety percent of all prostate cancers are found while they are still within the prostate itself or only in nearby areas, and the five-year relative survival rate for these men is nearly 100%. Being diagnosed with prostate cancer may represent a life-altering experience. A clear and in-depth knowledge of the patient’s condition and treatment options should help them make personal and individualized decisions.

PCA3 Test - Summary

“Men with elevated serum prostate-specific antigen (PSA) levels and negative prostate biopsy findings present a dilemma because of the lack of an accurate diagnostic test,” said Leonard S. Marks, MD, clinical associate professor of urology at UCLA and medical director of the Urological Sciences Research Foundation, who was the lead author of a study published in the journal of UROLOGY ® (69: 532-535, 2007). “The results from this research study indicate that the PCA3 assay may be a new tool to assist clinicians in the treatment of these ‘PSA dilemma’ patients.”

In 2000, recognizing the existence of unmet clinical needs for prostate cancer, DiagnoCure acquired from Nijmegen University (The Netherlands) an exclusive worldwide license for all diagnostic and therapeutic applications related to PCA3, a genetic marker highly specific to prostate cancer. DiagnoCure subsequently developed a first diagnostic application, called uPM3™, which enabled the detection of PCA3 RNA expression in prostate cancer cells found in urine.

In 2003, the Company signed a license and collaboration agreement with Gen-Probe Incorporated (NASDAQ: GPRO) for the development and commercialization of a second generation of the PCA3 test on Gen-Probe’s proprietary platform. Since 2005, the performance of Gen-Probe’s PCA3 research test has been validated at internationally respected institutions and presented at American and European scientific meetings. The test, developed in a quantitative format, has a proven analytical sensitivity superior to the original qualitative format of uPM3™. In a recent 233-men study published in the journal UROLOGY® (69:532-535, 2007), Gen-Probe’s research test predicted the results of repeat biopsies more accurately than the traditional prostate specific antigen (PSA) testing.

Several key opinion leaders meetings have been held at the meetings of the American Urological Association (AUA), the European Association of Urology (EAU) and other major conferences. These events constitute opportunities to discuss recent data on PCA3 with the worldwide leading experts in the field and to increase their awareness of PCA3. Several publications about PCA3 have also been released and plans are being made for additional such publications in order to increase the scientific community's awareness of PCA3.

The test is now available through laboratories in the U.S. using PCA3 analyte specific reagents (ASR) from Gen-Probe as well as in Europe as the CE-marked PROGENSA™ PCA3 in vitro assay. The test is also available through two Canadian laboratories.

Moreover, GlaxoSmithKline has appreciated the significance of the PCA3 marker by entering into an agreement with Gen-Probe for the use of the PCA3 assay in a clinical study with its drug – Avodart® (dutasteride). This study, to be carried out on 6,800 patients in 27 countries, should contribute to increased awareness of the PCA3 marker among urologists throughout the world.

During the first quarter of 2006, the parent patent on the PCA3 marker was issued in the United States, validating the uniqueness of this important new marker.

Research projects in prostate cancer

Within the on-going PCA3 research program, DiagnoCure has confirmed, in an in situ hybridization study, the high specificity of PCA3 RNA expression within prostate epithelial cells utilizing PCA3 probes on sections of prostate cancer tissue. In this study, PCA3 RNA expression at the level of tissue categorized as ASAP (atypical small acinar proliferation) was also observed. Some patients with an ASAP diagnosis develop cancer while others do not. The PCA3 RNA expression may help identify those patients who could develop a cancer. Consequently, in order to study the overall potential diagnostic role of the PCA3 marker, DiagnoCure has undertook in early 2005 a retrospective study on sections of prostate tissue from patients who have been identified as having ASAP and for whom the clinical evolution towards cancer or not is known.

Subsequetly, one area of research will target predicting the aggressiveness of individuals’ prostate cancer. Indeed, it is well known that not every prostate cancer will cause death, and as a result, some patients could live with their prostate cancer untreated and without being affected by undue medication or the side effects of prostate removal or other aggressive therapy. In that respect, DiagnoCure’s research could help physicians decide whether or not specific treatment is necessary by assessing the probability of the patient’s prostate cancer causing death.

[1]Specificity for a cut-off of 4.0ng/ml.
The role of complexed PSA and percent free PSA in prostate cancer detection, Prostate Update, The Canadian Prostate Health Council. S. Tanguay. August 2000, vol. 5, No 1.