# EORTC 22863

Source: https://onco.cc/trials/eortc-22863/  
OnCo record `eortc-22863` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The trial that proved hormone therapy should be added to radiotherapy for aggressive prostate cancer, and that the addition roughly halves the chance of dying of it.

## Summary

EORTC 22863 randomised 415 men with prostate cancer at high metastatic risk to radiotherapy alone or to radiotherapy with immediate androgen suppression. Radiotherapy was 50 Gy to the whole pelvis over 5 weeks with a 20 Gy boost to the prostate and seminal vesicles. Goserelin 3.6 mg was given every 4 weeks for 3 years starting on the first day of irradiation, with cyproterone acetate for the first month.

At a median 9.1 years, 10-year clinical disease-free survival was 47.7 percent (95 percent confidence interval 39.0 to 56.0) with combined treatment against 22.7 percent (16.3 to 29.7) with radiotherapy alone, hazard ratio 0.42 (0.33 to 0.55, p<0.0001). Ten-year overall survival was 58.1 percent (49.2 to 66.0) against 39.8 percent (31.9 to 47.5), hazard ratio 0.60 (0.45 to 0.80, p=0.0004), and 10-year prostate cancer mortality 10.3 percent (5.1 to 15.4) against 30.4 percent (23.2 to 37.5), hazard ratio 0.38 (0.24 to 0.60, p<0.0001).

The fear that long hormone therapy would kill men through their hearts was not borne out here: cardiovascular deaths did not differ significantly, whether or not men had cardiovascular problems at entry. Two fractures were reported in the combined arm. That reassurance has limits, because the trial is small and old, and modern evidence for bone and metabolic harm from long androgen deprivation is much stronger.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-25
- Also known as: EORTC 22863; Bolla trial
- Registry id: NCT00849082
- Phase: 3
- Setting: Prostate cancer at high risk of metastasis, T1 to T2 with WHO grade 3 or any T3 to T4: external beam radiotherapy alone against radiotherapy with 3 years of goserelin started on the first day of irradiation, with clinical disease-free survival as the primary endpoint
- Sponsor: European Organisation for Research and Treatment of Cancer
- Enrolled: 415
- Result: Ten-year overall survival 58.1 against 39.8 percent (hazard ratio 0.60, 95 percent confidence interval 0.45 to 0.80) and prostate cancer mortality 10.3 against 30.4 percent (0.38, 0.24 to 0.60) when 3 years of goserelin was added to radiotherapy.
- Outcomes: Clinical disease-free survival at 10 years: Radiotherapy with 3 years of goserelin 47.7% vs Radiotherapy alone 22.7%, HR 0.42; Overall survival at 10 years: Radiotherapy with 3 years of goserelin 58.1% vs Radiotherapy alone 39.8%, HR 0.6; Prostate cancer mortality at 10 years: Radiotherapy with 3 years of goserelin 10.3% vs Radiotherapy alone 30.4%, HR 0.38
- Replication: RTOG 8531 and SPCG-7 found the same direction; EORTC 22961 then showed that shortening the hormone therapy to 6 months gives up part of the gain.

## Sources

- ClinicalTrials.gov NCT00849082: https://clinicaltrials.gov/study/NCT00849082
- EORTC 22863 at 10 years (Lancet Oncology 2010): https://doi.org/10.1016/S1470-2045(10)70223-0

## Connected records

- cancers: [Localised prostate cancer, high and very high risk](https://onco.cc/cancers/prostate-high-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/)
- drugs: [Goserelin / leuprolide (ovarian function suppression)](https://onco.cc/drugs/goserelin/)
- companies: [EORTC](https://onco.cc/companies/curie-nki-eortc/)
- 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: [EORTC 22961](https://onco.cc/trials/eortc-22961/), [EORTC 22991](https://onco.cc/trials/eortc-22991/), [Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer](https://onco.cc/trials/nct00002633/), [RTOG 92-02](https://onco.cc/trials/rtog-9202/), [SPCG-7/SFUO-3](https://onco.cc/trials/spcg-7/)

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