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In men whose prostate cancer was found by a blood test, having the operation did not clearly help them live longer, and it left many more of them incontinent or unable to get an erection.
PIVOT randomised 731 men with localised prostate cancer, most of it detected by PSA testing, to radical prostatectomy or observation between November 1994 and January 2002, and followed them through August 2014.
Over 19.5 years of follow-up (median 12.7 years), 223 of 364 men (61.3 percent) assigned surgery and 245 of 367 (66.8 percent) assigned observation died: absolute difference 5.5 percentage points (95 percent confidence interval -1.5 to 12.4), hazard ratio 0.84 (0.70 to 1.01), p=0.06. Death attributed to prostate cancer or its treatment occurred in 27 men (7.4 percent) after surgery and 42 (11.4 percent) under observation: absolute difference 4.0 percentage points (-0.2 to 8.3), hazard ratio 0.63 (0.39 to 1.02), p=0.06. Neither reached significance.
The subgroup signal was in intermediate-risk disease, where surgery was associated with an absolute reduction in all-cause mortality of 14.5 percentage points (2.8 to 25.6), against 0.7 points (-10.5 to 11.8) in low-risk and 2.3 points (-11.5 to 16.1) in high-risk disease (p=0.08 for interaction).
What surgery reliably did was reduce treatment for progression, by 26.2 percentage points (19.0 to 32.9), almost all of it for asymptomatic local or PSA progression. What it reliably cost was continence and erections: urinary incontinence and erectile and sexual dysfunction were each more frequent after surgery through 10 years, and limitations in activities of daily living were greater through 2 years.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
731 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Death from any cause (median 12.7 years)primary | Radical prostatectomy | 364 | 61.3% | 0.84 (0.7 to 1.01) | 0.06 | link |
| Observation | 367 | 66.8% | ||||
| Death from prostate cancer or its treatment | Radical prostatectomy | 364 | 7.4% | 0.63 (0.39 to 1.02) | 0.06 | link |
| Observation | 367 | 11.4% |
Shares ProtecT, Active surveillance and observation, Quality of life and patient-reported outcomes (QoL, PRO), Localised prostate cancer, intermediate risk.
Shares Active surveillance and observation, PSA (prostate-specific antigen), Localised prostate cancer, very low and low risk, Active surveillance.
Shares ProtecT, Localised prostate cancer, intermediate risk, Localised prostate cancer, very low and low risk, Prostate cancer.
Shares ProtecT, Localised prostate cancer, intermediate risk, Localised prostate cancer, very low and low risk, Prostate cancer.
Shares Radical prostatectomy, PSA (prostate-specific antigen), Localised prostate cancer, intermediate risk, Localised prostate cancer, very low and low risk.
Shares ProtecT, Localised prostate cancer, intermediate risk, Localised prostate cancer, very low and low risk, Prostate cancer.
Shares Radical prostatectomy, PSA (prostate-specific antigen), Localised prostate cancer, intermediate risk, Localised prostate cancer, very low and low risk.
Shares Active surveillance and observation, Localised prostate cancer, intermediate risk, Localised prostate cancer, very low and low risk, Prostate cancer.