Data from the Prostate Cancer Intervention versus Observation Study (PIVOT) presented today in the plenary session of the 2011 annual meeting of American Urological Association (AUA) will have a major impact on the practice of Urology.
The VA/NCI/AHRQ cooperative study, initiated in 1994, was designed to assess the effect of radical prostatectomy (RP) compared to observation only or “watchful waiting” in men with localized prostate cancer.
What makes the PIVOT study so important is that it is the first randomized trial in the United States to look at RP versus “watchful waiting.” In all, 13,022 men were screened at 52 US centers, from which 5023 men were deemed eligible. Surprisingly, 4292 declined randomization and 731 men were enrolled in the trial.
The primary endpoint was all-cause mortality and the secondary endpoint, Prostate Cancer (PCa) mortality. The two groups of patients were comparable between the observation and RP groups (mean age 66.8, 67.0 years); PSA Mean (10.2, 10.1), Gleason Score < 6 (70.1%, 69.8%).
Timothy Wilt (Minnesota) presented the results today at AUA 2011 (Abstract#407)
- Absolute Risk Reduction (ARR) between Observation & RP = 2.9%,
- Hazard Ratio = 0.88 (95% 0.71-1.08), P=0.22
Prostate Cancer Mortality – all patients
- AR = 2.7% (95% CI -1.3 to 6.2)
- Hazard Ratio=0.63 (95% CI 0.36-1.09), p=0.09
In other words looking at the groups as a whole there was no benefit of RP on survival. Wilt presented further analysis on subgroups with low-risk local pathology, intermediate risk-local pathology and high risk PSA>10.
Only in the high-risk groups (PSA>10) was there a significant benefit to RP, in terms of lowering Prostate Cancer Mortality.
- HR= 0.36 (0.15 to 0.89); p=0.03
- ARR = 7.2% (0 to 14.8)
Wilt’s conclusion from the data was that compared to observation, RP produced
“reductions in all-cause and prostate cancer mortality that were not significant and less than 3% in absolute terms over 12 years.”
He added that:
“Surgery did not reduce mortality more than observation in men with low PSA or low risk from Prostate Cancer”
However, these “results suggest a benefit from surgery in men with higher PSA or higher risk of disease.”
The PIVOT trial provides evidence-based medicine results that will directly influence how urologists treat early stage prostate cancer. Several urologists and others at AUA tweeted about the PIVOT data. Using Storify, these provide some sentiments and perspective from practicing urologists in the live audience.
The conclusion from this data is that low risk, early stage prostate cancer patients should be observed by “watchful waiting” rather than undergo radical prostatectomy (RP). This may have a financial impact on urologists who previously may have favored RP in low risk patients.
Update May 23, 2011
A webcast with audio and slides of Dr Wilt’s plenary presentation of the PIVOT data is now available on the AUA website.
Update March 6, 2012
Dr Wilt presented an update on the PIVOT trial at the 2012 European Association of Urology (EAU) Congress in Paris. You can read my blog post from the meeting:
Update July 18, 2012
The data from the PIVOT trial presented in the plenary sessions at AUA 2011 and EAU 2012 has finally been published online first (July 18, 2012) in The New England Journal of Medicine.