Prostate Clinical Trials Participation

What are we measuring and why?

This indicator examines adult cancer clinical trial participation for prostate cancer relative to other major disease sites (breast, lung and colorectal). Clinical trial participation rates for adults are expressed as the ratio of cancer patients aged 19 years and older, newly enrolled in cancer-related therapeutic clinical trials or clinical research studies in 2013, to the number of cancer incident cases in 2013.

• Clinical trials are essential for developing new evidence-based methods and treatments. They introduce novel effective therapies into clinical practice and may reduce the use of ineffective and/or adverse therapies. The hoped-for endpoint is to improve patient outcomes.
• Data from other sources suggest that the cancer clinical trials system in Canada is facing difficulties for several reasons. These include increasing clinical trial complexity, a more onerous regulatory environment and increasing workloads for research ethics boards. In addition, although the number of cancer clinical trials opened per year had remained the same or increased from 2000-2010, patient enrolment per year had plateaued or decreased.
• Uncertainty around appropriate treatment options for prostate cancer patients is partially due to lack of randomized controlled trials investigating the benefits of different treatment options.¹ Studies are needed to produce recommendations and guidelines that will identify those men who are eligible for active surveillance and those who should undergo primary treatment. However, there have been some important trials to date that may change clinical practice (See the following What else do we know? Section to read more about pivotal clinical trial research).
• The National Comprehensive Cancer Network (NCCN) states in its Clinical Practice Guidelines in Oncology that the best management for cancer patients can be found within a clinical trial. Participation in clinical trials is especially encouraged for men with advanced prostate cancer.² Cancer Care Ontario’s Disease Pathway Management (DPM) model states that clinical trials should be considered for men in all phases of the prostate cancer treatment pathway (i.e., where trials are available and patients meet eligibility requirements).³

What are the results?

• In 2013, the adult clinical trial participation ratio for the four most common disease sites ranged from a low of 0.012 for lung cancer to a high of 0.050 for breast cancer (Figure 6.3). Prostate cancer had a clinical trial ratio of 0.032.
• There was interprovincial variation in adult clinical trial participation for prostate cancer. In 2013, the ratio of adult patients enrolled in clinical trials to cancer incident cases ranged from 0.019 in Nova Scotia to 0.052 in Saskatchewan (among the six reporting provinces) (Figure 6.4).

What do the results mean?

• Adult clinical trial participation rates in Canada are low. This is similar to rates in other countries worldwide including the United States; fewer than 3% of United States cancer patients participate in clinical trials.⁴ In contrast, the United Kingdom has a high rate of cancer clinical trial participation: in 2007/2008, 12% of adults diagnosed with cancer in the United Kingdom participated in cancer trials.⁵
• Several barriers to and facilitators of enrolment in prostate cancer clinical trials have been investigated. A Canadian study was the first to examine in detail the factors influencing enrolment.⁶ This study reported that younger patients were more likely to enrol in trials. Having their physicians recommend they take part in a clinical trial along with a desire to help those who will develop prostate cancer in the future were cited as strong facilitators to enrolment. As for barriers, men expressed concern about the randomization in clinical trials (i.e., they might be given a placebo vs. the treatment being studied and thus gain no benefit). Men also mentioned being worried about the time required to participate.

References

1. Grover SA, Coupal L, Zowall H, Rajan R, Trachtenberg J, Elhilali M, et al. The economic burden of prostate cancer in Canada: forecasts from the Montreal Prostate Cancer Model. CMAJ. 2000 Apr 4;162(7):987-92.
2. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer Version 2.2014. Chicago (IL): American Joint Committee on Cancer; 2014. 98 p.
3. Cancer Care Ontario. Prostate Cancer Treatment Pathway Version 2012.11 [Internet]. Cancer Care Ontario; 2012 [cited 2014 Sep 4]. Available from: https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=298448
4. Sinha G. United Kingdom becomes the cancer clinical trials recruitment capital of the world. J Natl Cancer Inst. 2007;99(6):420.
5. Stead M, Cameron D, Lester N, Parmar M, Haward R, Kaplan R, et al. Strengthening clinical cancer research in the United Kingdom. Br J Cancer. 2011 May 10;104(10):1529-34.
6. Davison BJ, So A, Goldenberg SL, Berkowitz J, Gleave ME. Measurement of factors influencing the participation of patients with prostate cancer in clinical trials: a Canadian perspective. BJU Int. 2008 Apr;101(8):982-7.