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The French version of the same question, and the same answer: treating everyone straight after surgery does not help, and it doubles the rate of lasting bladder and erection problems.
GETUG-AFU 17 enrolled 424 men at 46 French hospitals with pT3a, pT3b or pT4a disease and positive surgical margins after radical prostatectomy, randomised 1:1 to immediate adjuvant radiotherapy or delayed salvage radiotherapy at biochemical relapse. All men received 6 months of triptorelin. Enrolment was stopped early on the recommendation of the independent data monitoring committee because event rates were unexpectedly low; 718 had been planned.
At a median 75 months, 205 of 212 men (97 percent) in the adjuvant group started treatment, against 115 of 212 (54 percent) in the salvage group. Five-year event-free survival was 92 percent (95 percent confidence interval 86 to 95) with adjuvant radiotherapy and 90 percent (85 to 94) with salvage, hazard ratio 0.81 (0.48 to 1.36, log-rank p=0.42).
The toxicity difference was large. Late grade 2 or worse genitourinary adverse events occurred in 58 of 212 men (27 percent) after adjuvant radiotherapy against 14 of 212 (7 percent) after salvage (p<0.0001), and late erectile dysfunction of grade 2 or worse in 60 of 212 (28 percent) against 17 of 212 (8 percent) (p<0.0001). Acute grade 3 or worse effects were rare in both arms, six and four men respectively.
The authors were candid that the analysis lacked statistical power, which is why the ARTISTIC meta-analysis was designed in advance to pool the three trials.
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.
424 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survival at 5 yearsprimary | Adjuvant radiotherapy | 212 | 92% | 0.81 (0.48 to 1.36) | 0.42 | link |
| Delayed salvage radiotherapy | 212 | 90% | ||||
| Late grade 2 or worse erectile dysfunction | Adjuvant radiotherapy | 212 | 28% | - | <0.0001 | link |
| Delayed salvage radiotherapy | 212 | 8% |
Shares ARTISTIC meta-analysis, Salvage therapy, RADICALS-RT, Biochemical recurrence (BCR).
Shares ARTISTIC meta-analysis, RADICALS-RT, Biochemical recurrence (BCR), Radical prostatectomy.
Shares Salvage therapy, Biochemical recurrence (BCR), Radical prostatectomy, Biochemical recurrence of prostate cancer.
Shares Salvage therapy, RADICALS-RT, 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 Triptorelin, Ipsen, Prostate cancer.
Shares Biochemical recurrence (BCR), Localised prostate cancer, high and very high risk, Androgen deprivation & AR pathway inhibitors, IMRT / IGRT (modern external beam).
Shares Biochemical recurrence (BCR), Localised prostate cancer, high and very high risk, Androgen deprivation & AR pathway inhibitors, IMRT / IGRT (modern external beam).