Purpose

To determine in Ontario-based men with a single negative transrectal ultrasound-guided prostate biopsy the long-term rates of prostate cancer-specific mortality, diagnosis, and treatment; number of repeat biopsies; and predictors of prostate cancer diagnosis and mortality.

Materials and methods

This was a population-based cohort study, using data from linked, validated health administrative databases, of all Ontario-based men with a negative first biopsy between January 1994 and October 2014. Patients were followed from time of first biopsy till death, administrative censoring, or end of study period. Cumulative incidence functions were used to calculate the study outcomes’ cumulative incidences. Univariable and multivariable regression analyses using Fine and Gray's semiparametric proportional hazards model were used to assess predictors of prostate cancer diagnosis and mortality.

Results

The study cohort included 95,675 men with a median age of 63.0years. Median follow-up was 8.1years. The 20-year cumulative rates of prostate cancer-specific mortality and diagnosis were 1.8% and 23.7%, respectively. Men ages 70 to 79 and 80 to 84 at initial biopsy had 20-year prostate cancer-specific mortality cumulative rates of 3.2% and 6.4% respectively. The 20-year cumulative rate of receiving radical prostatectomy was 7.6%. Higher socioeconomic status and urban residence were associated with higher diagnosis risks yet lower prostate cancer-specific mortality risks.

Conclusions

This is the first population-based study assessing long-term cancer outcomes in North American men with a single negative transrectal ultrasound-guided prostate biopsy. Following a negative initial biopsy, 23.7% of men are still diagnosed with and 1.8% die of prostate cancer within 20years. Cancer-specific mortality outcomes are significantly worse in older men, with prostate cancer mortality rates several times higher than the rest of the population.

Background and purpose

Clinical trials organization can be daunting especially when orienting to a new system. The steps to a successful clinical trial are not concrete and vary based on the system.

Methods

In this section the discussion centers on how to shape the question for the clinical trial which is rational and feasible to answer within the planned study design.

Findings

Senior mentorship, collaboration and early involvement of stakeholders can help shape a successful clinical trial. Keeping in mind ethics and the processes within a system will make planning easier. Questions about key elements of the trial should be answered early to prevent delays of study initiation.

Conclusion

Clinical trial development and implementation can be very rewarding, but successful outcomes require careful planning and considerations.

Progress in the prevention, diagnosis, and treatment of genitourinary cancers is dependent on well-conducted clinical trials. The complexity and cost of clinical research continues to escalate, and success is dependent on adequate funding. Opportunities to fund such research include federal, industry, and private sources. The mechanisms whereby larger trials are conducted include contract research organizations, publically- and privately funded consortia, and the National Clinical Trials Network of the National Cancer Institute. The National Clinical Trials Network is the prime venue for investigators to conduct independent, phase III trials in the United States.