In this week’s NEJM, an article appears from a VA trial that was started in in 1994 and accrued patients through 2002. Of 13,002 patients who were diagnosed during this period, 5032 were eligible to participate but only 731 (~15%) men chose to do so. This highlights the first important issue: MEN do NOT participate in clinical trials the way women do. It’s a shame considering how many questions we have to answer. To be eligible, you had to be less than 75, fit for surgery, have PSA < 50, a small tumor, and a negative bone scan. (this applies to the majority of patients we see these days). The participants were then randomized to observation vs. surgery. WHOA, you mean some men were willing to NOT have treatment……yup…and hats off to the guys who participated !! Half of these guys were detected only because of PSA screening.
Of the 364 assigned to surgery, 281 had a radical and 53 didn’t – 14 had radiation. Among 367 assigned to observation, 36 changed their mind and had surgery and 29 received radiation therapy. By the end of the study, about half of the men had died. (the median survival was 13 years – sobering for those of us in our late 60’s) Only 52 of the deaths in the study were due to prostate cancer. Overall, the only group who benefited from treatment were those with PSA >10 in terms of prostate cancer deaths. “In contrast, among men with low-risk cancers (as determined by a PSA value < ng per milliliter, a score of 6 or less on the Gleason scale, and a stage T1a-c or T2a tumor), there was a 15% non significant increase [my emphasis] in mortality among men assigned to radical prostatectomy…” Intermediate-risk patients (PSA 10-20 or Gleason 7, or tumor on both sides of the prostate) had a 31% decrease risk of dying from all causes, but only 6 of the 59 deaths in this group were from prostate cancer.
For all those who feel that prostate cancer screening “saves lives”, this is a really important trial to know about. If NO treatment is better than treatment in many men, then one wonders why we should screen for this disease. The “cost” of treatment was pretty high. 81% of the surgery patients had erectile dysfunction and 17% had urinary incontinence. I am sure there will be a flurry of commentary in the news media this week. One question is whether the men who have been treated over the past decade will reconsider whether they made the right decision. I doubt it. Once treated, the most satisfying thought is that the side effects were “worth it to be cured” – a cure that might not have been needed – yet 90% of men with low risk disease receive either surgery or radiation.