You can either click on the question to get straight to the answer, or read the Questions and Answers from top to bottom

Questions:

  1. Is it possible for the PSA value to be elevated when there is no prostate carcinoma?
  2. What is the PCA3 Test?
  3. What is the role of the PCA3 Test in the diagnostic work-up of prostate carcinoma? How can I benefit from the PCA3 test?
  4. I am about to have a prostate biopsy.
    Can the PCA3 test replace a prostate biopsy?
    How does the PCA3 test help in making a decision about a biopsy?
  5. Practical urologists’ opinions on the PCA3 test.
  6. How is the PCA3 test performed?
  7. I would like to get the PCA3 test!
    What are the next steps?
  8. What is the scientific basis for the PCA3 test?
  9. The Progensa™ PCA3-Test at a glance.
  10. What does the PCA3 cost test and how can I get it reimbursed through my health insurance?
  11. More general information about prostate cancer
  12. Links and references to prostate cancer and diagnostics
  13. Glossary of prostate cancer and diagnostics terms

Answers:

1. Is it possible for the PSA value to be elevated when there is no prostate cancer?

An elevated PSA value is frequently a
trigger for carrying out a prostate biopsy, but it provides no evidence of prostate cancer.

In other words: an elevated PSA value does not automatically prove the existence of prostate cancer.

Indeed, in most cases involving an elevated PSA value prostate cancer has not been diagnosed.
In over 70% of the cases in which an elevated PSA value has been found, for example following suspicious findings during a digital
rectal examination, no prostate carcinoma was diagnosed.

Among others reasons, the following conditions may lead to elevated PSA values in the absence of prostate cancer:

  • prostate inflammation (prostatitis)
  • infections of the urogenital tract
  • benign prostate hyperplasia
  • mechanical impact on the prostate,
    (e.g. after a long bicycle trip)
  • ejaculation in the last 48 hrs
    (in individuals over 50 yrs. old)

In view of these problems with the specificity and positive predictive value of the PSA test, intensive research is being carried out to find better diagnostic tools that can be used in the diagnostic workup of suspected cases of prostate cancer.

Yes, I would like a PCA3 test
How should I proceed? What is the next step?

2. What is the PCA3 Test?

In the search for a novel diagnostic test for prostate cancer, the
PCA3-molecule was discovered
(don’t confuse PCA3 with PSA).
Concentrations of the PCA3 molecule are 100 times higher
in prostate cancer cells than in normal prostate cells.

As a result of digital rectal examination, prostate cells – including potentially cancerous cells -
are released into the urine.
These cells
can be detected in urine samples obtained after such an examination. This procedure is
much less invasive for the
patient
than a prostate biopsy.

For this reason, laboratory tests have been developed to detect PCA3 in urine.

A test for PCA3 detection in urine has been brought to market by the Californian biotech company Gen-Probe Incorporated
(San Diego) under the trade name “Progensa™ PCA3 test”.

This assay is being offered by Noviogendix for routine testing of urine samples.

The diagnostic relevance and reliability of the assay has been substantiated by scientific studies that analyzed males
with suspected prostate cancer before a first biopsy, as well as males undergoing repeated prostate biopsies. These studies
revealed that the PCA3 test can be used to predict the result of a biopsy and that it can be used to help schedule a prostate biopsy.

Yes, I would like a PCA3 test
How should I proceed? What is the next step?

3. What is the role of the PCA3 Test in the diagnostic work-up of prostate carcinoma? How can I benefit from the PCA3 test?

Removal of tissue from the prostate (a prostate biopsy, using of a biopsy needle) is currently the only method that conclusively proves the existence of prostate cancer after suspicious findings in a digital rectal examination or
discovery of an elevated PSA value.

There are two reasons (indications) for carrying out a prostate biopsy:

  1. Changes in the prostate (induration), as detected by digital rectal examination, or
  2. an elevated parameter measured in blood, i.e. if the prostate
    specific antigen (PSA) is above 2.5 – 6.5 ng/mL, depending on the age of the individual.

However, an elevated PSA value is not specific to prostate cancer, as there may be many other reasons for this finding.

Even if a prostate biopsy has been performed and no carcinoma was found (i.e. the biopsy was negative), this does not rule out
prostate cancer, since the biopsy needle may have missed the localized cancer tissue. In this case, the doctor and the
patient must together decide whether biopsies should be repeated or whether they should “wait and watch”.

In many cases repeated biopsies are recommended. These are, however, harmful for the
patient and may also have undesired side effects.

First, a prostate biopsy may cause pain, bleeding and infections. Second, repeated biopsies may reveal small cancers
that otherwise would not require treatment or for which treatment is not recommended.

The PCA3 test can support the decision as to whether and when a prostate biopsy should be done, in particular for
males with an elevated PSA value, in which a previous biopsy did not reveal any pathological findings (negative).

Recend studies provide evidence that the PCA3 test may also provide information on the malignancy of an existing prostate cancer.

Yes, I would like a PCA3 test
How should I proceed? What is the next step?

4. I am about to have a prostate biopsy
Can the PCA3 test replace a prostate biopsy?
How does the PCA3 test help in making a decision about a biopsy?

The Progensa™ PCA3 test is not a replacement for a prostate biopsy

But the PCA3 test result can be a significant criterion in discussing the need for a biopsy. This is
particularly true for males with an elevated PSA value in which an earlier biopsy was unsuspicious (“negative”).

The result of a PCA3 test, given additional clinical and laboratory findings as well
as the patient’s history, may lead to the joint decision between the patient and the doctor not to carry out a repeat biopsy.

You can read a summary of the scientific basis for this conclusion here

Latest research results demonstrate that the PCA3 test results make it possible to estimate the malignancy
of an existing prostate cancer. This may result in sparing patients invasive therapy, should the test result
indicate that the patient suffers from a carcinoma with a low malignant potential.

You can read the opinions of practical urologists on the PCA3-test here

Yes, I would like a PCA3 test
How should I proceed? What is the next step?

5. Opinions of practical urologists on the PCA3 test

Prof. Dr. med. Bernd Schmitz-Draeger (Fürth, Germany) states:

“… with a PCA3 score below 35 the risk for prostate cancer is decreased, above it is
elevated.” Moreover he states “Let’s take a patient with a very low PCA3 value of – say
- 5: this patient has a three-time lower risk as other patients with a similar PSA
value. If we assume the risk for prostate cancer at 25% in patients with a PSA value
between 4,0 and 10,0 ng/ml, then the patient with a low PCA3 score has a risk of 8%.
This does not provide final certainty, but causes relief for the patient and the
doctor.”

(From: andrologen.info, Feb. 2008)

The urological practitioner Dr. med. Heribert Schorn (Göttingen, Germany) answers the question “Which patients do you recommend the test?” as follows:

“Patients with elevated PSA-values and/or unfavourable ratio of free PSA without a finding from palpation, especially when prostatitis is known from the patients history. I recommend the test for anxious patients, who want to “circumvent” a biopsy. It is also reasonable in cases of increased risk for a biopsy – e.g. in patients under coumadin treatment, increased bleeding tendency, poorly managed diabetes or significant coronary artery disease. This is also true for patients for whom a re-biopsy is being discussed.”

(From: andrologen.info, Feb. 2008)

Yes, I would like a PCA3 test
How should I proceed? What is the next step?

6. How is the PCA3 test performed?

The Progensa™ PCA3 test offered by Noviogendix measures the PCA3 level in urine.

For the patient the test is simple and uncomplicated.

First, the doctor carries out a digital rectal examination of the prostate. Then a urine sample is
collected. The urine sample is sent to the laboratory where it is analyzed by specially trained
personnel by using the PCA3 test.

The lab report provides a graphical display of the individual laboratory finding and a detailed interpretation.
A copy for the patient is included.

The result is displayed as so-called “PCA3 score”: the lower the score, the lower the probability of cancer detection
by a subsequent biopsy (“positive biopsy”).

Yes, I would like a PCA3 test
How should I proceed? What is the next step?

7. I would like to take a PCA3 test!
What are the next steps?

Your urologist performs the assay in collaboration with Noviogendix.

Please consult your urologist and ask for the PCA3 test. Your doctor will provide
all the necessary information and tell you what you need to do.

You can request information for doctors, including scientific literature, information about sample generation and transportation
by using the following fax form below or by sending an email to P.Peelen@noviogendix.nl.

You may wish to print this fax form and hand it to your doctor’s team. The team will then take the necessary actions.

Download the fax form here

Or you may wish to order the form by e-mail here: P.Peelen@noviogendix.nl.

After you have discussed the benefits of the PCA3 test with your urologist, your urologist can order the PCA3 test including
instruction at NovioGendix
.

On request we send the urine collection tube to your urologist and when the urine obtained after DRE (digital rectal examination)
has been sent to us, we deliver the test result within 3 to 4 business days to your urologist (we guarantee a maximum of 7 business days).

8. What is the scientific basis for the PCA3 test?

Scientific studies in the USA and Europe have assessed whether the Progensa™ PCA3 test can be used to predict
the result of subsequent biopsies and/or therapy.

In these studies the PCA3 test has been used with patients with suspected prostate cancer as well as those undergoing
repeated biopsies.

Indeed, it was found that the PCA3 score correlates well with the results of subsequent prostate biopsies: in men with
a high PCA3 score the probability of a positive finding in the biopsy was higher.

For men with a PCA3 score equal to or greater than 35 the propapility of for a positive biopsy was 43%. With a PCA3
score equal to or below 5, a positive biopsy was found in 10% of patients.

Read below the opinions of practical urologists

Scientific references:

  • Marks et al.

    “PCA3 molecular urine assay for prostate cancer in men undergoing repeat biopsy.”
    Urology 2007; 69:53 -535

  • Haese et al.

    “The value of the PCA3 assay in guiding decision as to which men with a negative prostate biopsy need immediate
    repeat biopsy: preliminary European data.”

    Eur Urol Suppl 2007; 6:48 (abstr. 101)

  • Nakanishi et al.

    “PCA3 molecular urine assay correlates with prostate cancer tumor volume: implications for selecting candidates
    for active surveillance.”

    J Urol 2008,179:1804-1809

  • Deras et al.

    “PCA3: a molecular urine assay for predicting prostate biopsy outcome.”

    J Urol 2008; 179:1587–1592

Yes, I would like a PCA3 test
How should I proceed? What is the next step?

9. The Progensa™ PCA3 test at a glance

  • The Progensa™ PCA3 test is the first molecular genetic assay with high specificity for prostate cancer to be made
    available in routine patient care.
  • The burden for the patient is minimal: after routine digital examination a urine sample is being collected and
    analyzed.
  • Scientific studies demonstrate that the Progensa™ PCA3 test provides predictive information that is relevant to better
    decision making concerning a prostate biopsy:
    • The result of the PCA3 test correlates with the result of a subsequent biopsy and with the clinical significance of
      an existing prostate carcinoma
    • A low PCA3 score correlates with a lower probability of prostate carcinoma.
  • Taken together, all existing results show that the number of unnecessary biopsies can be
    reduced when the PCA3 test is used
Yes, I would like a PCA3 test
How should I proceed? What is the next step?

10. What does the PCA3 test cost and how can I get it reimbursed through my Health Insurance?

Reimbursement depends on the insurance status and may vary between individuals. For information please consult your attending urologist, your insurance provider or send your question via email to P.Peelen@noviogendix.nl.

Yes, I would like a PCA3 test
How should I proceed? What is the next step?

11. More general information about prostate cancer

The prostate is a gland in the male reproductive system. When cells of the prostate
develop into cancer, they may spread (“metastasize”) to other parts of the body,
especially the bone and the lymph nodes.

Prostate cancer is most often suspected after so-called “PSA screening” and less commonly
by rectal digital examination. Suspected prostate cancer is typically confirmed by
taking a needle biopsy of the prostate and examining thin tissue sections of this
biopsy under the microscope.

Treatment options for prostate cancer are primarily surgery, irradiation, hormonal therapy,
and chemotherapy, depending on the clinical stage of the disease and the status of the patient.

A good survey on the aspects of prostate cancer is given in Wikipedia

Yes, I would like a PCA3 test
How should I proceed? What is the next step?

12. Links and references to prostate cancer and diagnostics

Comprehensive information on current medical developments pertinent to prostate cancer are provided by the “Prostate Cancer Research Institute (PCRI)”

http://www.prostate-cancer.org/

The website of Gen-Probe Inc., the company which brought the PCA3 test to market

http://www.gen-probe.com/

The website of he National Center for Biotechnology Information (NCBI), where you may search for primary and secondary scientific information on PCA3 and prostate cancer

http://www.ncbi.nlm.nih.gov/

A database of NCBI, called “Online Mendelian Inheritance in Man”, which provides detailed molecular information on biomolecules, including PSA or PCA3

http://www.ncbi.nlm.nih.gov/sites/entrez

A Wikipedia article on PSA (prostate-specific antigen)

http://en.wikipedia.org/wiki/Prostate_specific_antigen

A Wikipedia article on prostate cancer

http://en.wikipedia.org/wiki/Prostate_cancer

A Wikipedia article on PCA3

http://en.wikipedia.org/wiki/PCA3

Yes, I would like a PCA3 test
How should I proceed? What is the next step?

13. Glossary about prostate cancer and diagnostics

Digital rectal examination (DRE):

The examination by a physician whom uses a lubricated and gloved finger inserted into the
rectum to feel for abnormalities of the prostate, anus and rectum. Withrespect to the prostate
the physicvian judges on the gland’s size, shape, consistence and mobility.

Malignant:

The term describes the character of a severe and progressively worsening disease. Usually the term describes cancer, since .- by definition – cancers are always malignant

Prostate biopsy:

Removal of small pieces of tissue from the prostate by using a biopsy needle in order to check for abnormalities
such as cancer. So-called “tissue sections” of the biopsy are examined under the microscope by a pathologist
in order to make a precise diagnosis of the prostate’s structure and condition, to see whether there are
cancerous (“malignant”) alterations.

Oncology:

The division of medical science dealing with the diagnosis and treatment of cancer. An oncologist
is a physician who is specialized in cancer treatment.

PSA:

Abbreviation for “Prostate-Specific Antigen”: a protein produced by the cells of the prostate
gland including cancer cells; an elevated level in the blood indicates an abnormal condition
of the prostate gland, either benign or malignant. It is used to detect potential problems in
the prostate gland (“screening”) and to follow the progress of prostate cancer therapy (“monitoring”).

Screening:

Diagnostic evaluating of large numbers of people to detect disease early.

Sensitivity:

Statistical measure to describe the proportion of actual positives that are correctly identified as
such. In medical diagnostics a sensitivity of 100 % means that the test recognizes all sick people
as such.

More information in Wikipedia

Specificity:

Statistical measure to describe the proportion of negatives which have are correctly
identified. In a medical diagnostic test a specificity of 100 % means that the test recognizes
all healthy people as healthy

More information in Wikipedia

Urologist:

A doctor initially trained as surgeon who is specialized in urology, a d division of medicine dealing
with disorders of the male and female urinary tract, as well as the male genital tract.

More definitions pertinent to prostate cancer under
PCRI

Yes, I would like a PCA3 test
How should I proceed? What is the next step?

More information on PCA3 and Noviogendix

can be found here

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