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The trial that proved an operation for prostate cancer can save a life, in men whose cancer was found because of symptoms rather than a blood test, and that the average gain is about three years.
SPCG-4 randomised 695 men with clinically detected localised prostate cancer to radical prostatectomy or watchful waiting between October 1989 and February 1999, and followed them to the end of 2017. These were not screen-detected cancers: most were found because the man had symptoms or an abnormal examination, so the trial says nothing directly about the tumours a PSA test finds.
By 31 December 2017, 261 of 347 men in the prostatectomy group and 292 of 348 in the watchful-waiting group had died. Seventy-one deaths in the prostatectomy group and 110 in the watchful-waiting group were from prostate cancer: relative risk 0.55 (95 percent confidence interval 0.41 to 0.74, p<0.001), an absolute difference of 11.7 percentage points (5.2 to 18.2). The number needed to treat to avert one death from any cause was 8.4. At 23 years, a mean of 2.9 extra years of life had been gained with surgery.
The trial also produced the two pathological features that still drive counselling after an operation: extracapsular extension carried a risk of death from prostate cancer five times that of men without it, and a Gleason score above 7 carried a risk ten times that of a score of 6 or lower.
SPCG-4 and PIVOT are usually read as contradicting each other. They do not: SPCG-4 treated clinically detected cancers in the pre-PSA era and found a benefit, PIVOT treated mostly PSA-detected cancers and did not. The lesson is that the benefit of surgery depends entirely on how the cancer was found.
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.
695 randomised.
Relative risk 0.55 (95 percent confidence interval 0.41 to 0.74); absolute difference 11.7 percentage points.
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Death from prostate cancer at 29 yearsprimary | Radical prostatectomy | 347 | 71 men | - | <0.001 | link |
| Watchful waiting | 348 | 110 men | ||||
| Death from any cause at 29 years | Radical prostatectomy | 347 | 261 men | - | - | link |
| Watchful waiting | 348 | 292 men |
Shares Active surveillance and observation, Gleason score / Grade Group, Localised prostate cancer, intermediate risk, Localised prostate cancer, very low and low risk.
Shares ProtecT, Active surveillance and observation, Gleason score / Grade Group, Localised prostate cancer, intermediate risk.
Shares Radical prostatectomy, Gleason score / Grade Group, Localised prostate cancer, intermediate risk, Localised prostate cancer, very low and low risk.
Shares Active surveillance and observation, Gleason score / Grade Group, 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 ProtecT, Localised prostate cancer, intermediate risk, Localised prostate cancer, very low and low risk, Prostate cancer.
Shares Radical prostatectomy, Gleason score / Grade Group, Localised prostate cancer, intermediate risk, Localised prostate cancer, very low and low risk.
Shares Radical prostatectomy, Localised prostate cancer, intermediate risk, Localised prostate cancer, very low and low risk, Localised prostate cancer, high and very high risk.