Complications after radical prostatectomy and radical external beam radiation therapy for early prostate cancer

The diagnosis of prostate cancer has increased more than two-fold between 1991 and 1996, and most of the additional 200,000 patients diagnosed annually have early (non-metastatic) prostate cancer. Unfortunately, the preferred treatment for these men cannot be determined based on proven differences in survival outcomes, since definitive comparisons between surgery and radiotherapy (and observation with delayed hormonal therapy) have not been performed. Both of the most common treatments for early prostate cancer have known effects on bladder, bowel and sexual functions, which are a prioriimportant to patient quality of life, and, because of the indolent natural history of early prostate cancer (the vast majority will live 5 years or more), patients will experience any permanent complications for years. Studies with rigorous methodology to assess treatment-related complications have until recently not been performed. Reports of complications in single treatment modality case series are limited because of treatment selections bias, which results in prostatectomy patient populations which are younger and healthier and have less advanced cancers compared to radiotherapy populations. Also, patients may minimize their symptoms to their treating physicians, resulting in underestimates of complication rates. Recent retrospective surveys of treated patients have found higher complication rates than the treatment case series had reported, which supports the existence of this reporting problem. Therefore, we have initiated two prospective cohort studies, a300-patient pilot study and a 600-patient follow-up study, at Harvard Medical School-affiliated institutions to assess more accurately complication rates in patients treated for early prostate cancer. To be sure that complications are due to treatment alone rather than to pretreatment status, which is particularly important given treatment selection bias, we collect pretreatment symptom information as well as other patient demographic and prognostic variables and then follow patients prospectively. We use the techniques of survey research to provide clear and unambiguous questions and to remove the potentially confounding interactions between the patient and this treating physician. These studies provide clear descriptions of the distinct patterns of toxicity following radiotherapy and surgery, and confirm the higher complication rates for both modalities suggested by retrospective patient surveys