# RTOG 94-08

Source: https://onco.cc/trials/rtog-9408/  
OnCo record `rtog-9408` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-25
- Also known as: RTOG 9408; RTOG 94-08
- Registry id: NCT00002597
- Phase: 3
- Setting: Stage T1b, T1c, T2a or T2b prostate adenocarcinoma with PSA of 20 or less: radiotherapy alone against radiotherapy with 4 months of total androgen suppression starting 2 months before it, with overall survival as the primary endpoint
- Sponsor: Radiation Therapy Oncology Group, now NRG Oncology, funded by the National Cancer Institute
- Enrolled: 1979
- Result: Ten-year overall survival 62 against 57 percent (hazard ratio for death with radiotherapy alone 1.17, p=0.03) and disease-specific mortality 4 against 8 percent; benefit confined to intermediate-risk men on post-hoc analysis.
- Outcomes: Overall survival at 10 years: Radiotherapy with 4 months of androgen suppression 62% vs Radiotherapy alone 57%, HR 1.17; Disease-specific mortality at 10 years: Radiotherapy with 4 months of androgen suppression 4% vs Radiotherapy alone 8%, HR 1.87
- Replication: EORTC 22991 found the same for 6 months of androgen suppression added to dose-escalated radiotherapy in 819 men, with a biochemical disease-free survival hazard ratio of 0.52.

## Sources

- ClinicalTrials.gov NCT00002597: https://clinicaltrials.gov/study/NCT00002597
- RTOG 94-08 (New England Journal of Medicine 2011): https://doi.org/10.1056/NEJMoa1012348

## Connected records

- cancers: [Localised prostate cancer, intermediate risk](https://onco.cc/cancers/prostate-intermediate-risk/), [Localised prostate cancer, very low and low risk](https://onco.cc/cancers/prostate-low-risk/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [Androgen deprivation & AR pathway inhibitors](https://onco.cc/technologies/androgen-deprivation/), [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/)
- companies: [NRG Oncology](https://onco.cc/companies/nrg-oncology/)
- terms: [Androgen deprivation therapy (ADT)](https://onco.cc/terms/adt/), [Curative intent vs palliative intent](https://onco.cc/terms/curative-intent/), [Hormone therapy](https://onco.cc/terms/hormone-therapy/)
- trials: [CHHiP](https://onco.cc/trials/chhip/), [EORTC 22991](https://onco.cc/trials/eortc-22991/), [RTOG 92-02](https://onco.cc/trials/rtog-9202/)

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