It doesn’t tell us a great deal, but we are pleased to note the earliest publication of data from the Prostate cancer Intervention Versus Observation Trial (PIVOT), a multicenter, randomized, controlled clinical trial initiated in 1994 to compare the effects of watchful waiting to radical prostatectomy in men with localized prostate cancer.
The article by Wilt et al. reports the following baseline data:
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13,022 men were screened at 52 United States medical centers for potential enrollment.
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5,023 patients met initial age, comorbidity, and disease eligibility criteria.
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731 men agreed to participate and were randomized.
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The mean age of enrollees was 67 years.
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Nearly one-third were African-American.
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Approximately 85 percent reported they were fully active.
The following, additional data is also provided:
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The median PSA level of the enrollees was 7.8 ng/ml (mean 10.2 ng/ml).
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For 75 percent of men the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise.
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Approximately 43 percent of enrollees had low risk disease, 36 percent had medium risk disease, and 20 percent had high-risk prostate cancer.
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Comparison to our national sample of eligible men declining PIVOT participation as well as to men enrolled in the earlier Scandinavian trial indicated that PIVOT enrollees are representative of men being diagnosed and treated in the U.S. and quite different from men in the Scandinavian trial.
PIVOT was designed to yield important information regarding the relative effectiveness and harms of surgery compared to watchful waiting for men with predominately PSA-detected, clinically localized prostate cancer.
Filed under: Management, Treatment Tagged: | PIVOT, surgery, watchful waiting
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The abstract seems to say that we’ve finally got a randomized study – stand by for news… but not much else.
I don’t understand why the abstract doesn’t say when the final report is due out.
With 1/3 African and their risk factors, shouldn’t the results should be a worst case scenario?
Actually I believe that the data provided tell us a great deal more than you are suggesting.
In the first place they tell us how hard it was to enroll men into this trial. Only 1 in 7 eligible men were willing to participate. In the second place they tell us something about the potential power of the trial, which is not as high as originally intended. The original estimate of the number of patients to be enrolled was 1050 patients. Thirdly, the inclusion of this many African-American patients is a very good thing because it allows for the possibility that we can tell whether either Caucasians or African-Americans have different outcomes.
The projected date of completion of this trial was originally given as November 2009. My understanding is that this date is still viable.
I do have a concern that with only 730 patients as opposed to the original projection of 1,050, the statistical power of this trial to provide meaningful outcome data may have been severely compromised, but I am not a statistician.
This is the first time I comment here and I should say that you give us genuine, and quality information for bloggers! Good job.
P.S.: You have a very good template for your blog. Where did you find it?
Thanks for your kind comment.
This web site/blog is build on WordPress.com using the “Digg 3 Column” design, all of which is available free through WordPress, although obviously we have added visual custom features.
I was diagnosed with prostate cancer in 2005 and have been avidly awaiting these results since then. They are supposed to be available in short order .
For all its flaws (and there are a number of these), the PIVOT trial represents an important attempt to elucidate the relative merits of the major treatment options for localized prostate cancer. We shall comment futher on the data from PIVOT as soon as they are available.