In a landmark study published in the New England Journal of Medicine, Dr. Wilt and the PIVOT Study Group reported the results of the first randomized controlled study of radical prostatectomy versus observation for the treatment of prostate cancer in the modern PSA (prostate cancer screening) era. The study randomized 731 men with clinically localized prostate cancer and found that radical prostatectomy did not significantly improve overall or cancer specific survival as compared to observation.
Subgroup analysis revealed that men with intermediate or high risk prostate cancer may benefit from surgery with regards to metastasis and cancer specific survival. As expected, radical prostatectomy was associated with significantly higher rates of urinary incontinence and erectile dysfunction, but not bowel dysfunction.
Overall, this study adds to the growing body of evidence of the over-diagnosis and over-treatment of low-risk prostate cancer. But it also confirms the benefit of treatment in men with intermediate and high risk prostate cancer.
There are several important findings from the study:
• While the findings may not be applicable to younger men (only 10 percent of the patients were less than 60 years old), the results strongly support observation or active surveillance as the primary treatment strategy for men with low risk prostate cancer.
• Among men with a PSA >10 ng/mL, surgery was associated with a 33 percent reduction in all cause mortality and 64 percent reduction in prostate cancer-related mortality.
• Among men with intermediate and high risk prostate cancer, surgery significantly reduced the risk of prostate cancer progression to bone metastasis.
Given the known lead time between prostate cancer diagnosis and death, it will be interesting to see the results after longer follow up.