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Adding six months of hormone therapy to radiotherapy given for a rising PSA after prostate surgery raised the proportion free of progression at ten years from about half to about two thirds.
GETUG-AFU 16 randomised 743 men whose PSA had risen from 0.1 to between 0.2 and 2.0 ng/mL after radical prostatectomy to salvage radiotherapy alone or salvage radiotherapy with short-term androgen suppression, given as 10.8 mg subcutaneous goserelin on the first day of irradiation and 3 months later. Radiotherapy was 66 Gy in 33 fractions, five days a week for 7 weeks, by three-dimensional conformal or intensity-modulated technique.
At the March 2019 cutoff, median follow-up 112 months, 120-month progression-free survival was 64 percent (95 percent confidence interval 58 to 69) with radiotherapy plus goserelin and 49 percent (43 to 54) with radiotherapy alone, hazard ratio 0.54 (0.43 to 0.68, stratified log-rank p<0.0001). Two secondary cancers occurred after the primary analysis and neither was considered treatment related. There were no treatment-related deaths.
The trial answers a narrow and practical question. It does not tell a man whether 6 months is the right duration, which RADICALS-HD addressed with a 6 against 24 month comparison, nor whether the pelvic nodes should be treated, which SPPORT addressed.
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.
743 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival at 120 monthsprimary | Salvage radiotherapy with 6 months of goserelin | 369 | 64% | 0.54 (0.43 to 0.68) | <0.0001 | link |
| Salvage radiotherapy alone | 374 | 49% |
Shares Salvage therapy, Biochemical recurrence (BCR), Radical prostatectomy, Biochemical recurrence of prostate cancer.
Shares Salvage therapy, Biochemical recurrence (BCR), Radical prostatectomy, Biochemical recurrence of prostate cancer.
Shares Salvage therapy, RADICALS-HD, Biochemical recurrence (BCR), Radical prostatectomy.
Shares Salvage therapy, Biochemical recurrence (BCR), Radical prostatectomy, Biochemical recurrence of prostate cancer.
Shares Salvage therapy, Biochemical recurrence (BCR), Radical prostatectomy, Biochemical recurrence of prostate cancer.
Shares EMBARK, Biochemical recurrence (BCR), Androgen deprivation therapy (ADT), Biochemical recurrence of prostate cancer.
Shares Biochemical recurrence (BCR), Radical prostatectomy, Biochemical recurrence of prostate cancer, IMRT / IGRT (modern external beam).
Shares Biochemical recurrence (BCR), Androgen deprivation therapy (ADT), Androgen deprivation & AR pathway inhibitors, IMRT / IGRT (modern external beam).