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Four months of hormone therapy added to radiotherapy helped men with intermediate-risk prostate cancer live longer, and did nothing for men with low-risk disease.
RTOG 94-08 randomly assigned 1,979 eligible men with stage T1b to T2b prostate adenocarcinoma and a PSA of 20 or less to radiotherapy alone (992) or radiotherapy with 4 months of total androgen suppression beginning 2 months before radiotherapy (987).
At a median 9.1 years, 10-year overall survival was 62 percent with combined treatment against 57 percent with radiotherapy alone, hazard ratio for death with radiotherapy alone 1.17, p=0.03. Ten-year disease-specific mortality fell from 8 to 4 percent, hazard ratio 1.87, p=0.001. Biochemical failure, distant metastases and positive repeat biopsy at 2 years all improved.
The post-hoc risk analysis is what changed practice: the reductions in overall and disease-specific mortality were concentrated in intermediate-risk men, with no significant reduction in low-risk men. That is why a man with low-risk disease having radiotherapy today is usually offered no hormone therapy at all, and a man with intermediate-risk disease is offered 4 to 6 months.
Toxicity was modest. Acute and late radiation effects were similar in the two groups and grade 3 or higher hormone-related effects occurred in under 5 percent.
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.
1,979 randomised.
Hazard ratio is for death with radiotherapy alone.
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival at 10 yearsprimary | Radiotherapy with 4 months of androgen suppression | 987 | 62% | 1.17 | 0.03 | link |
| Radiotherapy alone | 992 | 57% | ||||
| Disease-specific mortality at 10 years | Radiotherapy with 4 months of androgen suppression | 987 | 4% | 1.87 | 0.001 | link |
| Radiotherapy alone | 992 | 8% |
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