Media backgrounder – The START clinical trial

13  September  2007
TORONTO -

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 Corporation, 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 release: Landmark study to determine best approach to treating prostate cancer

Media backgrounder: prostate cancer

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. When you want to know more about cancer, visit our website www.cancer.ca or call our toll-free, bilingual Cancer Information Service at 1 888 939-3333.

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For more information, please contact:

Alexa Giorgi

Bilingual Communications Specialist

Canadian Cancer Society, National office

Phone:  (416) 934-5338

Karen Ramlall

Manager, Communications

Canadian Cancer Society, National Office

Phone:  (416) 934-5341