Leading Approach To Reduce Prostate Cancer Overtreatment To Be Championed Worldwide

Active surveillance, a Canadian-conceived and unprecedented approach to reduce overtreatment and radical treatment side effects in men with low-grade prostate cancer is being championed worldwide with the launch of an international multi-centre study START (Surveillance Therapy Against Radical Treatment) to definitively prove the effectiveness of Surveillance Therapy in a randomized setting.

"With the widespread use of prostate-specific antigen (PSA) testing, men have been increasingly identified as having prostate cancer. 50 per cent of newly- diagnosed patients generally have low-grade prostate cancer with favourable risk and in the past about 90 per cent of these men were treated radically. Active surveillance with selected delayed intervention aims to reduce overtreatment," says Dr. Laurence Klotz, the study’s lead investigator, urologic oncologist and a member of the prostate cancer research group at Sunnybrook Health Sciences Centre who conceived of the approach.

Active surveillance with selective delayed intervention has already been validated in the successful treatment of more than 500 Canadian men at Sunnybrook and is premised on shared patient decision-making. The approach involves men with low-grade prostate cancer, to closely monitor them, to follow their PSA, to calculate their PSA doubling time, re-biopsy them periodically, and to only intervene with patients who over time re-classify as high risk for progression or death from disease.

"The driving force behind active surveillance is maintaining quality of life. To take someone who is not really at risk and give them a treatment that has a permanent effect on their erectile function and their bowel function is a serious thing to do to someone. You only want to radically treat the ones who need it," says Dr. Klotz, head of the Genitourinary Site Group, Odette Cancer Centre at Sunnybrook, and professor, Department of Surgery, University of Toronto.

Tom Lepoidevin was diagnosed with low-grade prostate cancer 16 years ago and opted to forego surgery and participate in active surveillance. Tom says the approach made sense for him especially to avoid the risks of surgery and possible side effects. "With reassurance that I would be monitored and watched carefully, it was fine. Every once in a while you say to yourself ‘gosh I have cancer’…you go through that psychological time of saying wouldn’t you be better off and wouldn’t you feel better if it was eradicated. But you get past that stage. I’m carrying on, I’m not in pain. All is okay."

The large-scale international START study will be conducted initially in ten sites across Canada, 15 sites in United States, and five sites in United Kingdom. After one year, the plan is to open the study at numerous sites in Canada, United States and United Kingdom. The study will enroll 2,100 newly-diagnosed low-grade prostate cancer patients with a 15-year follow-up. Participants will be randomized to surgery, radiation or active surveillance, and the approaches will be compared.

Key criteria for patients defined as having low-grade prostate cancer patients with favourable-risk are patients with a PSA in the low to intermediate range and who have a small volume of cancer as detected through biopsy.

This study is funded in Canada by the National Cancer Institute of Canada.