Grant R01CA108746

Prostatectomy vs watchful waiting - a randomized trial.

DESCRIPTION (provided by applicant): The long-term objective is to improve the prerequisites for evidence-based management of patients with an early, localized prostate cancer. This requires integration of data about effects on both survival and quality of life after long-term follow-up. The proposed study builds on a clinical trial in Sweden and Finland initiated in1989. In that trial, altogether 695 men with newly diagnosed, clinically localized (TOd, T1-2), diagnosed through 1999, were randomized to radical prostatectomy (N=347) or watchful waiting (N=348). After a median follow-up of 6.4 years, radical prostatectomy reduced mortality due to prostate cancer by 50 percent whilst overall mortality was not statistically significantly reduced. Unexpectedly, radical prostatectomy did not deteriorate the self-assessed quality of life as compared with watchful waiting. Our specific aims during an additional 5 years of intense follow-up reaching a medium of almost 11 years are to study whether 1) the absolute and relative survival benefit from radical prostatectomy increases over time, 2) a significant reduction in overall mortality can be documented after long-term follow-up, 3) the survival time following establishment of metastatic disease is longer in patients treated with radical prostatectomy than in those left with no prior treatment, 4) PSA doubling time before establishment of metastatic diseases is shorter in patients who have undergone radical prostatectomy than in those managed by watchful waiting!, 5) on an average, radical prostatectomy improves sense of well-being, self-assessed quality of life and of meaningfulness as compared with watchful waiting, 6) the symptom burden of disease increases more rapidly over time among patients managed by watchful waiting, 7) quality of life is higher following radical prostatectomy due to more successful counseling by the managing doctor, 8) support from next-of-kin and relatives is, due to a higher awareness of the disease, better after radical prostatectomy than after watchful waiting, increasing quality of life, 9) unspecific symptoms are more worrisome to patients managed by watchful waiting than to those treated by radical prostatectomy. The research methods include firstly continued complete follow-up on PSA monitoring, recurrence, treatment, and cause of death among those deceased and, secondly, an ambitious assessment of quality of life chiefly by means of qualitative interviews and self-administered questionnaires. Long-term results from this unique trial may provide information highly relevant for the counseling and clinical management of large numbers of patients with an early prostate cancer diagnosed clinically or by means of PSA-testing.