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Three trials asked the same question and none was big enough alone. Pooling them, planned in advance so nobody could cherry-pick, showed that waiting for the PSA to rise is as good as treating everyone.
The ARTISTIC collaboration is a model of how to settle a question that no single trial can answer. The investigators of RADICALS-RT, RAVES and GETUG-AFU 17 agreed a harmonised definition of event-free survival and registered a protocol on PROSPERO before any of the trial results were known, so the pooling could not be shaped by what came out.
Event-free survival was defined as the time from randomisation to the first of biochemical progression (PSA of 0.4 ng/mL or more and rising after any postoperative radiotherapy), clinical or radiological progression, start of a non-trial treatment, death from prostate cancer, or a PSA of at least 2.0 ng/mL at any time. Updated results were obtained for 2,153 men recruited between November 2007 and December 2016, 1,075 assigned adjuvant radiotherapy and 1,078 a policy of early salvage radiotherapy, of whom 421 (39.1 percent) had started treatment at the time of analysis. Median follow-up ranged from 60 to 78 months. Median age was 64 or 65 across trials and 1,671 men (77.6 percent) had a Gleason score of 7. All three trials were assessed as at low risk of bias.
On 270 events there was no evidence that adjuvant radiotherapy improved event-free survival: hazard ratio 0.95 (95 percent confidence interval 0.75 to 1.21, p=0.70), a change in 5-year event-free survival of 1 percentage point (-2 to 3), 89 against 88 percent. Results were consistent across trials (heterogeneity p=0.18, I-squared 42 percent).
The conclusion, that early salvage treatment is preferable because it spares many men radiotherapy and its side effects, is the practice today. The honest caveat the authors made is that long-term outcomes, including metastasis and death, are still awaited.
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.
2,153 analysed.
5-year event-free survival
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survivalprimary | Adjuvant radiotherapy | 1,075 | 89% | 0.95 (0.75 to 1.21) | 0.70 | link |
| Policy of early salvage radiotherapy | 1,078 | 88% |
Shares Salvage therapy, RADICALS-RT, MRC Clinical Trials Unit at UCL, Radical prostatectomy.
Shares Salvage therapy, Biochemical recurrence (BCR), Radical prostatectomy, Biochemical recurrence of prostate cancer.
Shares Biochemical recurrence (BCR), Radical prostatectomy, Biochemical recurrence of prostate cancer, Localised prostate cancer, high and very high risk.
Shares Biochemical recurrence (BCR), Radical prostatectomy, Localised prostate cancer, high and very high risk, Prostate cancer.
Shares Biochemical recurrence (BCR), Localised prostate cancer, high and very high risk, IMRT / IGRT (modern external beam), Prostate cancer.
Shares Biochemical recurrence (BCR), Localised prostate cancer, high and very high risk, IMRT / IGRT (modern external beam), Prostate cancer.
Shares Radical prostatectomy, Localised prostate cancer, high and very high risk, IMRT / IGRT (modern external beam), Prostate cancer.
Shares Biochemical recurrence (BCR), Biochemical recurrence of prostate cancer, Prostate cancer.