Landmark study to determine best approach to treating prostate cancer



    Clinical trial to examine options for most common cancer for men

    TORONTO, Sept. 13 /CNW/ - The Canadian Cancer Society, in collaboration
with the National Cancer Institute of Canada Clinical Trials Group, is
announcing the launch of the first international study that will help answer
one of the thorniest questions in prostate cancer today - which patients
benefit from aggressive treatment at the time of diagnosis.
    When a man is diagnosed with localized prostate cancer which does not
appear to be clinically aggressive, one of the biggest choices he faces is
whether to choose immediate treatment or "active surveillance." Active
surveillance is a treatment strategy whereby a patient does not receive
therapy right away but is monitored regularly to track the progress of the
condition and offered treatment if it appears that the cancer warrants
therapy. Currently, there is no strong scientific evidence to guide patients
or their doctors on which approach is best for patients whose cancer is
favourable risk.
    "It's really important that we determine which option is best," says Dr.
Laurence Klotz, the study's lead researcher and a urologist at Sunnybrook
Health Sciences Centre. "Many patients diagnosed with prostate cancer do
perfectly well without treatment. While we know we can usually successfully
treat the disease, what we don't know is which patients will require immediate
treatment, later treatment or even treatment at all."
    "A diagnosis of prostate cancer can be a stressful time for both the man
and his family," says Heather Logan, Canadian Cancer Society director of
cancer control policy. "Our hope is that this research will provide
information so that some men can avoid unnecessary treatment as there can be
significant side effects."
    Treatment for prostate cancer can cause erectile dysfunction, rectal
damage and problems with urinary control.
    Prostate cancer can be a slow growing disease and, unlike many other
types of cancer, it may not pose a threat to the life or well-being of many
men who have the disease. In many cases, prostate cancer causes few or no
problems to men during their lifetime, and they may eventually die from some
other cause. Treating the disease aggressively, and suffering the resulting
side effects, is not beneficial to the patient in every case.
    "If the prostate cancer is aggressive, there is no question that
treatment will save lives," Dr. Klotz says. "But for about 50 per cent of
patients, the threat of the disease is less clear."
    The clinical trial, called the START trial (Surveillance Therapy Against
Radical Treatment), will compare standard treatment for prostate cancer -
either surgery or radiation - to active surveillance. It will enrol and follow
2,130 newly-diagnosed patients with low-risk prostate cancer in Canada, the
U.S., England and Europe. Half of the patients will be randomly selected for
treatment and the other half will be selected to be closely monitored during
regular physician visits.
    Results are expected in about 15 years but may be known earlier if it
appears that the surveillance arm is as good as or it is significantly worse
than the standard treatment arm based on interim analyses.
    "We expect that the results of this trial will help men with prostate
cancer and their physicians to make the best choice about their treatment
plan," says Dr. Barbara Whylie, CEO, Canadian Cancer Society. "We're pleased
to be announcing the launch of this trial on the eve of Prostate Cancer
Awareness Week in Canada."
    Men looking for more information on the START trial and participating
study centres in their community should contact the Canadian Cancer Society's
toll-free, bilingual Cancer Information Service at 1 888 939-3333.
    In Canada, prostate cancer is the most commonly diagnosed cancer in men
and the third most common cause of cancer death in men. An estimated 22,300
men will be diagnosed with prostate cancer this year and about 4,300 will die
from the disease.
    Prostate Cancer Awareness Week is September 17-23. During this week, the
Canadian Cancer Society works to raise awareness about prostate cancer among
Canadian men.
    The Canadian Cancer Society is a national community-based organization of
volunteers whose mission is to eradicate cancer and to enhance the quality of
life of people living with cancer. It is the largest charitable funder of
cancer research in Canada. This year, the Society is funding more than 
$47 million in leading-edge research projects across the country.

    When you want to know more about prostate cancer, or to obtain a free
prostate health kit, call the Society's toll-free, bilingual Cancer
Information Service at 1 888 939-3333. You can also visit our website at
www.cancer.ca.

    The National Cancer Institute of Canada Clinical Trials Group is funded
by the Canadian Cancer Society and is based at Queen's University in Kingston,
Ont. The Clinical Trials Group has participated in many groundbreaking trials
that have helped change treatment or improve the quality of life for cancer
patients worldwide.


    Media backgrounder - The START clinical trial

    Why is this clinical trial important?

    With funding from the Canadian Cancer Society, the START clinical trial
will answer one of the thorniest questions in prostate cancer today - whether
or not, and when, to start aggressive treatment.
    More specifically, it will determine if all newly-diagnosed patients with
favourable risk cancer need to be treated with surgery or radiation when they
are initially diagnosed or if most of these patients can be monitored closely
and treated only if necessary.
    The study will also look at the impact of the disease and the side
effects of treatment on the quality of life of all patients participating in
the study. In addition, the study will examine the differences in anxiety
experienced by patients - an important consideration when comparing such
different treatment strategies.

    What kind of treatment will men receive?

    
    Men will be randomly assigned to one of two groups:

    -   Initial standard treatment such as surgery or radiation - Men in this
        group will select the appropriate therapy with their physician.
    -   Active surveillance - Men in this group will be closely observed,
        including:
           -   A physician visit every three months for two years and then
               every 6 months for life
           -   A prostate specific antigen (PSA) test and a digital rectal
               exam at each visit
           -   A prostate biopsy one year after entering the study and again
               at three- to five-year intervals

           If testing shows that a patient's cancer has progressed, he will
           be offered treatment - either surgery or radiation.

           All patients in the active surveillance group will have the option
           to choose treatment at any time.

    Who can join this clinical trial?

    Researchers hope to enrol 2,130 men from the Canada, the United States and
England.

    To be eligible, men must have low risk prostate cancer, defined as:

    -   Gleason score of six or less: Gleason score measures the appearance
        of tumour cells.
    -   PSA levels of 10 or less
    -   T-stage of two or less: T-stage measures the extent a cancer has
        spread from the original site to other parts of the body.
    

    Participants must also have an average life expectancy greater than 10
years.
    Men with a Gleason grade of seven or greater, or a T-stage of three or
greater, or a PSA above 10 are not eligible. These men are considered to have
intermediate or high risk disease. If these men have a life expectancy of
greater than 10 years, they should have treatment.

    Where is it taking place?

    The study will take place in approximately 100 study centres in Canada,
the United States and England.

    
    The first centres will open in Canada and will include the following
institutions:

    -   Clinical Research Unit at Vancouver Coastal Health Authority,
        Vancouver
    -   University of Alberta, Edmonton
    -   Tom Baker Cancer Centre - Holy Cross Site Calgary
    -   Cancer Care Manitoba, Winnipeg
    -   London Health Sciences Centre
    -   Sunnybrook Health Sciences Centre, Toronto
    -   Princess Margaret Hospital, Toronto
    -   St. Joseph's Hospital, Hamilton
    -   Ottawa Civic Hospital
    -   McGill University Health Centre, Montreal
    -   CHUM Hopital Notre-Dame, Montreal
    -   CHUQ Hotel-Dieu de Quebec, Quebec City
    -   Centre hospitalier universitaire de Sherbrooke
    -   QEII HSC - Nova Scotia Cancer Centre, Halifax
    -   Atlantic Health Sciences Cooperation, Saint John
    

    How do men sign up?

    Men who meet the eligibility criteria should contact our toll-free,
bilingual Cancer Information Service at 1 888 939 3333.

    Lead researchers:

    Canada
    ------
    Laurence Klotz, M.D.
    Chief, Division of Urology, Sunnybrook Health Sciences Centre
    Chair, Canadian Uro-Oncology Group and NCIC GU Site Group

    United States
    -------------
    Adam S. Kibel, M.D.
    Director, Urologic Oncology, Division of Urology, Washington University
    Division of Urologic Surgery, Barnes Jewish Hospital

    Martin Sanda, M.D.
    Director, Prostate Cancer Center Beth Israel Deaconess Medical Center
    Co-chair, Eastern Cooperative Oncology Group

    Ian Thompson, M.D.
    Professor and Chair, Department of Urology, University of Texas Health
    Science Center
    Co-chair, Southwest Oncology Group

    England
    -------
    Noel Clarke
    Co-chair, National Cancer Research Institute Cancer Research Group

    The Canadian Cancer Society is a national community-based organization of
volunteers whose mission is to eradicate cancer and to enhance the quality of
life of people living with cancer. It is the largest charitable funder of
cancer research in Canada. This year, the Society is funding more than
$47 million in leading-edge research projects across the country.


    Media backgrounder: prostate cancer

    
    The facts

    -   Prostate cancer is the most commonly diagnosed cancer in men and the
        third most common cause of cancer death in men.

    -   An estimated 22,300 men will be diagnosed with prostate cancer in
        Canada in 2007. An estimated 4,300 will die from the disease.

    -   A man has a 1 in 8 chance of developing prostate cancer in his
        lifetime.

    -   Death rates for prostate cancer dropped by 2.7% annually between 1994
        and 2003.

    Symptoms of prostate cancer

           -   decrease in the size and force of your urinary stream (weak,
               interrupted flow)

           -   difficulty starting (hesitancy) or stopping urine flow
              (dribbling)

           -   urgent need to urinate

           -   frequent urination during the day and especially at night

           -   inability to urinate

           -   blood in your urine

           -   pain during ejaculation
    

    If men have any of these symptoms, they should see their doctor. Having
these symptoms does not necessarily mean you have prostate cancer. They could
be caused by other prostate problems.

    Canadian Cancer Society recommendation

    The Canadian Cancer Society recommends that all men over the age of 50
discuss with their doctor the potential benefits and risks of early detection
of prostate cancer using Prostate Specific Antigen (PSA) and digital rectal
examinations (DRE) so that they can make informed decisions about the use of
these tests.
    Men at higher risk because of family history or those of African ancestry
should discuss the need for testing at an earlier age.

    What we're doing

    
    The Canadian Cancer Society works across Canada to ensure that no one is
alone in the fight against cancer. As Canada's leader in the fight against
cancer, we:
    -   support excellent prostate cancer research

    -   educate men about early detection

    -   provide information and support to men living with prostate cancer,
        their families and their caregivers

    Prostate cancer research

    The Canadian Cancer Society is providing close to $2.5 million in
2007-2008 to fund a broad range of prostate cancer research projects across
the country through the National Cancer Institute of Canada and the Canadian
Prostate Cancer Research Initiative. Current research includes:

    -   Research into the development of a new therapy for prostate cancer,
        using light to activate photodynamic drugs. This therapy is designed
        to selectively destroy prostate cancer cells while leaving healthy
        cells unharmed, resulting in fewer side effects and a better quality
        of life for the patient.

    -   A clinical trial aimed at determining if a giving a supplement of
        vitamin E, selenium and soy protein to men with a prostate condition
        that is a precursor to prostate cancer will prevent the disease from
        developing.

    -   Research looking at how to improve brachytherapy - a promising
        prostate cancer treatment approach whereby tiny radioactive seeds are
        implanted in the tumour. The results of this study may lead to the
        development of more precise ways of treating patients while reducing
        side effects.
    

    Prostate Cancer Awareness Week, September 17-23

    During Prostate Cancer Awareness Week activities take place in
communities across Canada to raise awareness of the disease among Canadian
men.





For further information:

For further information: Alexa Giorgi, Bilingual Communications
Specialist, (416) 934-5681; Karen Ramlall, Communications Manager, (416)
934-5655


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