# RTOG 9601

Source: https://onco.cc/trials/rtog-9601/  
OnCo record `rtog-9601` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

RTOG 9601 showed that adding two years of hormone therapy to salvage radiotherapy after prostate surgery lengthens survival, mainly in men with higher PSA levels at relapse.

## Summary

RTOG 9601 randomised 760 men with a rising PSA after radical prostatectomy to salvage radiotherapy (64.8 Gy) with 24 months of bicalutamide 150 mg or placebo. Twelve-year overall survival was 76.3 percent with bicalutamide and 71.3 percent with placebo (hazard ratio 0.77), with fewer prostate cancer deaths and metastases; the benefit was concentrated in men with PSA above 0.7 ng/mL, and gynaecomastia was common (Shipley and colleagues, New England Journal of Medicine 2017).

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Tags: radiation-wave4
- Registry id: NCT00002874
- Phase: 3
- Setting: Rising PSA after prostatectomy: salvage radiotherapy with two years of bicalutamide versus salvage radiotherapy with placebo
- Sponsor: Radiation Therapy Oncology Group
- Enrolled: 760
- Result: 12-year overall survival 76.3% vs 71.3% (hazard ratio 0.77); benefit mainly with PSA above 0.7 ng/mL.
- Outcomes: Overall survival at 12 years: Salvage radiotherapy plus bicalutamide 76.3% vs Salvage radiotherapy plus placebo 71.3%

## Sources

- ClinicalTrials.gov NCT00002874: https://clinicaltrials.gov/study/NCT00002874
- NEJM 2017: https://doi.org/10.1056/NEJMoa1607529

## Connected records

- cancers: [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/)
- drugs: [Bicalutamide](https://onco.cc/drugs/bicalutamide/)

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