Application for Gen PCA3 material (prostate cancer)

A new assay (PROGENSA PCA3 of Gen-Probe) that detects the

presence of PCA3 mRNA and PSA mRNA from a urine sample by a
molecular method of transcription amplification (TMA).
The diagnosis of prostate cancer is currently based on the
determination of PSA levels and the Digital Rectal Examination. The
results of both tests sometimes require a prostate biopsy to confirm the
diagnosis of prostate cancer.
The new urine test emerges with the purpose of discriminating if it is
really necessary to perform this invasive test. Also, because it
significantly improves the Positive Predictive Value (PPV) with respect
to Prostate Biopsy, it will better identify patients who will have a
positive biopsy later. Unlike PSA, the PCA3 gene is widely overexposed
in more than 95% of prostate cancer tissues, compared to benign
tumor prostate tissue and normal prostate tissue from the same
patient. Therefore, the Positive Predictive Value is at least twice the
PSA (75% compared to 38%).
Response time: You can have the results in 14 days.
Our laboratory supplies the necessary material for the collection of
samples (special transport tube with two black marks, pasteur pipette,
traditional urine canister and collection bottle for transport tube).
Procedure for the collection of samples: Perform a Rectal Touch by
applying enough pressure to the prostate to depress approximately
1cm the surface in both postero-anterior and lateral direction of each
lobe. Repeat the process three times in order to ensure a sufficient
number of prostate cells. Then collect the first 20 to 20 mL of urine in
the urine bottle provided. Cover said boat and invert the sample 5
times. Transfer, in the first 15 minutes, 2 to 3 mL of urine to the
special transport tube supplied, filling it to the two black marks. Close
the tube firmly and invert several times to homogenize the sample.
Storage of the sample: The samples can be stored under these
conditions and are stable for up to 5 days, always at room
temperature.
Report and interpretation of the result: The new test detects the
presence of PCA3 mRNA and PSA mRNA from a urine sample by a
molecular method of transcription amplification (TMA). The mRNA
and PSA are quantified, calculating a PCA3 ratio based on the ratio:
1000 x [mRNA PCA3] / [mRNA PSA]. The measurement of PSA
mRNA serves to normalize the PCA3 signal and to confirm that the
production of specific prostatic RNA is sufficient to generate a valid
result. The high results of the PCA3 ratio correlate with high
probability of a positive prostatic biopsy.
The PCA3 ratio was obtained from a study of 529 men (mean age of 64
years) with a mean total PSA of 7.9 ng / mL. Prostate biopsies were
positive in 180 patients (34%), so that the higher the ratio of PCA3, the
higher percentage of men with a positive biopsy. A ratio of PCA3 of 35
provided the highest diagnostic safety, balance between sensitivity
(53%) and specificity (74%).
The PCA3 Test is considered positive if the PCA3 ratio is sup. or equal
to 35, so that a patient with a sup ratio. or equal to 35 has a high
probability of having a prostate cancer, while a patient with a ratio of
less than 35 has a low probability of having a prostate cancer:
• A Ratio sup. or equal to 35 correlates with a high probability of
positive biopsy.
• An inf. to 35 correlates with a low probability of positive biopsy.
Furthermore, a PCA3 ratio of 35 is able to differentiate the normal
man (<45 years and without known risk factors for prostate cancer)
from the man with benign prostatic hyperplasia, with untreated
prostate cancer and with prostate cancer treated with radical
prostatectomy.
Finally, it should be noted that in the same population, the mean serum
PSA total was increased with the greater volume of the prostate gland,
while the mean PCA3 ratio was not influenced by the prostate size,
which suggests that PCA3 is independent of prostate volume and
therefore more specific for prostate cancer than Total PSA