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Two years of hormone therapy alongside radiotherapy after prostate surgery kept the cancer from spreading in six more men in a hundred than six months did, at the cost of more side effects.
RADICALS-HD randomised 1,523 men, median age 65, at 138 centres in Canada, Denmark, Ireland and the United Kingdom to add 6 months of androgen deprivation (761) or 24 months (762) to postoperative radiotherapy. Androgen deprivation could be a monthly or 3-monthly gonadotrophin-releasing hormone analogue, daily oral bicalutamide 150 mg, or monthly subcutaneous degarelix. The comparison had over 80 percent power to detect an increase in 10-year metastasis-free survival from 75 to 81 percent.
At a median 8.9 years and 313 metastasis-free survival events, long-course treatment was better: 174 events on short-course against 139 on long-course, hazard ratio 0.773 (95 percent confidence interval 0.612 to 0.975, p=0.029). Ten-year metastasis-free survival was 71.9 percent (67.6 to 75.7) with 6 months and 78.1 percent (74.2 to 81.5) with 24 months.
The cost is stated plainly in the paper: grade 3 or higher toxicity in 105 of 753 men (14 percent) on short-course against 142 of 757 (19 percent) on long-course (p=0.025), with no treatment-related deaths. The authors framed the recommendation as conditional, for individuals who can accept the additional duration of adverse effects, which is the right way to put a 6 percentage point gain against eighteen extra months of castration.
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.
1,523 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Metastasis-free survival at 10 yearsprimary | Long-course androgen deprivation, 24 months | 762 | 78.1% | 0.773 (0.612 to 0.975) | 0.029 | link |
| Short-course androgen deprivation, 6 months | 761 | 71.9% | ||||
| Grade 3 or higher toxicity | Long-course androgen deprivation, 24 months | 757 | 19% | - | 0.025 | link |
| Short-course androgen deprivation, 6 months | 753 | 14% |
Shares Salvage therapy, RADICALS-RT, MRC Clinical Trials Unit at UCL, Radical prostatectomy.
Shares What androgen deprivation costs: the side of hormone therapy the survival curves do not show, MRC Clinical Trials Unit at UCL, Hormone therapy, Androgen deprivation therapy (ADT).
Shares Salvage therapy, RADICALS-RT, Radical prostatectomy, Biochemical recurrence of prostate cancer.
Shares Salvage therapy, RADICALS-RT, Radical prostatectomy, Biochemical recurrence of prostate cancer.
Shares Salvage therapy, RADICALS-RT, Radical prostatectomy, Biochemical recurrence of prostate cancer.
Shares What androgen deprivation costs: the side of hormone therapy the survival curves do not show, Hormone therapy, Bicalutamide, Androgen deprivation therapy (ADT).
Shares What androgen deprivation costs: the side of hormone therapy the survival curves do not show, Hormone therapy, Androgen deprivation therapy (ADT), Localised prostate cancer, high and very high risk.
Shares Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer, GETUG-AFU 16, Bicalutamide, IMRT / IGRT (modern external beam).