Gen-Probe announced yesterday that it has begun a clinical trial designed to seek U.S. regulatory approval of the PROGENSA® PCA3 assay.
“Based on the results of our extensive clinical research studies and our European commercial experience, we believe that our PROGENSA PCA3 assay can help predict the risk of a positive follow-up biopsy, thereby improving patient care,” said Eric Lai, PhD, Gen-Probe’s senior vice president of research and development.
The study is expected to take less than a year, and will enroll about 500 men, all of whom have had a negative prostate biopsy, at 10 or more clinical trial sites. However, there is no information about this trial available on the ClinicalTrials.gov web site (as of the time of writing).
Such a study, if successful, would allow Gen-Probe to market their PCA3 test only for the evaluation of prostate cancer risk in patients who had had at least one negative biopsy.
Filed under: Diagnosis, Risk Tagged: | clinical trial, PCA3, Progensa
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My urologist is going to be doing a PCA3 test on me in October. To date, I have had two negative biopsies, however, my PSA reading is 6.8. I have been on Avodart for 2 years, which my doctor says significantly reduces the true PSA level by close to half. I would be most interested in participating in any clinical trials that may be available. He notes that my prostate is extremely large, which in and by itself, could be the cause of the high PSA levels. I have also had bladder cancer, stage 1, grade 3.
Thank you for any information you may be able to provide.
Phil Beauharnois
Dear Mr. Beauharnois:
You would need to contact Gen-Probe and/or your urologist to learn how to participate in this trial.
What is the process that will result in PCA3 being approved for a screen to determine if the initial biopsy is appropriate? When is this approval likely to occur?
Dear Brady:
According to Gen-Probe, the trial that is being run will take about a year. So, if the trial is successful, it might take about 2 years from now before the data are analyzed and the Food and Drug Administration could approve the Progensa PCA3 test as suitable for the evaluation of prostate cancer risk in patients who have had at least one negative biopsy.
At present, the PCA3 test is only available erxperimentally, and it has nopt been approved by the FDA.
The PCA3 test is currently available here in the States in an ASR format. There are a number of labs that currently offer the test (and the top 3-5 labs all offer it).
http://www.PCA3.org is a good site to read up on the test.