This is a study funded by the US government, specifically the Department of Veteran Affairs, National Cancer Institute and the Agency for Healthcare Research and Quality. It is known as the PIVOT study (Prostate Cancer versus Observation Trial).

From November 1994 through January 2002, the researchers randomly assigned 731 men with localized prostate cancer  to radical prostatectomy or observation with palliative care and followed them through January 2010. The primary outcome was all-cause mortality (death rate from any cause); the secondary outcome was prostate cancer mortality (rate of death from prostate cancer).

Over a median period of 10 years:

Death from ANY cause

• Surgery:  171 of 364 men (47.0%)
• Observation: 183 of 367 (49.9%)

When you look just at death from prostate cancer:

• Surgery: 21 (5.8%)
• Observation: 31 men (8.4%)

Critical Analysis:

Due to the limitations in patient accrual, the study was underpowered. Additionally, about a fifth of the patients in both groups did not adhere to the plan and went ahead with a different treatment like surgery or radiation. More analysis may be read here written in the editorial of the study.

Personal Take:

I think that this study highlights a few important points.

1. Patients with low risk prostate cancer will not likely die of the disease over a decade from diagnosis. This has been highlighted in many studies and is yet more proof that an Active Surveillance protocol will aid in managing patients with low risk disease until we have more evidence of a more aggressive cancer.

2. Patients with intermediate risk disease will likely benefit with surgery.

3. High risk prostate cancer may not be cured with surgery alone because of its aggressive nature. But it certainly doesn’t rule out as an option.

The problem we have is the lack of any better diagnostic tests to determine the full extent of disease … meaning, unless we remove the entire prostate. PSA is helpful but not reliable unless the PSA is very high. Our imaging is currently useless, though there may be some promising work in 3 Tesla Endorectal MRI’s. Nevertheless, our only best test for diagnosis of prostate cancer with at least 12 core needle biopsies still under-grades the disease (meaning there is Gleason 7 or 8 disease when we remove the whole prostate, but we thought it was just a Gleason 6 before surgery) in about 30% of cases.

Will all this information in hand, I would strongly recommend surgery in a patient with at least 15 yr life expectancy with intermediate-high risk disease. Also, would offer Active Surveillance to low risk patients interested in pursuing that versus surgery.