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Even when the radiation dose is pushed high, two more years of hormone therapy still improves survival for men with high-risk prostate cancer.
DART 01/05 GICOR tested whether escalating the radiation dose removes the need for long androgen deprivation. It randomised 355 men at ten Spanish university hospitals to 4 months of neoadjuvant and concomitant androgen deprivation with high-dose three-dimensional conformal radiotherapy of at least 76 Gy (range 76 to 82 Gy), or the same followed by 24 months of adjuvant androgen deprivation. Anti-androgen therapy, flutamide 750 mg or bicalutamide 50 mg daily, was added during the first 2 months.
At a median 63 months, 5-year biochemical disease-free survival was 90 percent (95 percent confidence interval 87 to 92) with long-course treatment against 81 percent (78 to 85) with short-course, hazard ratio 1.88 (1.12 to 3.15, p=0.01). Five-year overall survival was 95 percent (93 to 97) against 86 percent (83 to 89), hazard ratio 2.48 (1.31 to 4.68, p=0.009), and 5-year metastasis-free survival 94 percent (92 to 96) against 83 percent (80 to 86), hazard ratio 2.31 (1.23 to 3.85, p=0.01). The effect was more evident in high-risk than in lower-risk men.
Late toxicity did not differ: grade 3 late rectal toxicity in three of 177 long-course and two of 178 short-course men, grade 3 to 4 late urinary toxicity in five men in each group, and no treatment-related deaths. The authors were explicit that longer follow-up is needed before concluding that intermediate-risk men benefit from more than 4 months.
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.
355 randomised.
Hazard ratio is for failure with short-course treatment.
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Biochemical disease-free survival at 5 yearsprimary | Long-course androgen deprivation, 28 months total | 177 | 90% | 1.88 (1.12 to 3.15) | 0.01 | link |
| Short-course androgen deprivation, 4 months | 178 | 81% | ||||
| Overall survival at 5 years | Long-course androgen deprivation, 28 months total | 177 | 95% | 2.48 (1.31 to 4.68) | 0.009 | link |
| Short-course androgen deprivation, 4 months | 178 | 86% |
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