# RADICALS-HD

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

## TL;DR

Two years of hormone therapy alongside radiotherapy after prostate surgery kept the cancer from spreading in six more men in a hundred than six months did, at the cost of more side effects.

## Summary

RADICALS-HD randomised 1,523 men, median age 65, at 138 centres in Canada, Denmark, Ireland and the United Kingdom to add 6 months of androgen deprivation (761) or 24 months (762) to postoperative radiotherapy. Androgen deprivation could be a monthly or 3-monthly gonadotrophin-releasing hormone analogue, daily oral bicalutamide 150 mg, or monthly subcutaneous degarelix. The comparison had over 80 percent power to detect an increase in 10-year metastasis-free survival from 75 to 81 percent.

At a median 8.9 years and 313 metastasis-free survival events, long-course treatment was better: 174 events on short-course against 139 on long-course, hazard ratio 0.773 (95 percent confidence interval 0.612 to 0.975, p=0.029). Ten-year metastasis-free survival was 71.9 percent (67.6 to 75.7) with 6 months and 78.1 percent (74.2 to 81.5) with 24 months.

The cost is stated plainly in the paper: grade 3 or higher toxicity in 105 of 753 men (14 percent) on short-course against 142 of 757 (19 percent) on long-course (p=0.025), with no treatment-related deaths. The authors framed the recommendation as conditional, for individuals who can accept the additional duration of adverse effects, which is the right way to put a 6 percentage point gain against eighteen extra months of castration.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-25
- Also known as: RADICALS-HD; RADICALS hormone duration comparison
- Registry id: ISRCTN40814031
- Phase: 3
- Setting: Postoperative radiotherapy after radical prostatectomy with a PSA below 5 and no metastatic disease: 6 months of androgen deprivation against 24 months, given as a gonadotrophin-releasing hormone analogue, bicalutamide 150 mg daily or degarelix, with metastasis-free survival as the primary outcome
- Sponsor: MRC Clinical Trials Unit at UCL, funded by Cancer Research UK, UK Research and Innovation and the Canadian Cancer Society
- Enrolled: 1523
- Result: Ten-year metastasis-free survival 78.1 percent with 24 months of androgen deprivation against 71.9 percent with 6 months (hazard ratio 0.773, 95 percent confidence interval 0.612 to 0.975, p=0.029); grade 3 or higher toxicity 19 against 14 percent.
- Outcomes: Metastasis-free survival at 10 years: Long-course androgen deprivation, 24 months 78.1% vs Short-course androgen deprivation, 6 months 71.9%, HR 0.773; Grade 3 or higher toxicity: Long-course androgen deprivation, 24 months 19% vs Short-course androgen deprivation, 6 months 14%
- Replication: Consistent in direction with GETUG-AFU 16, which showed that adding 6 months of goserelin to salvage radiotherapy improves progression-free survival, and with SPPORT, which added pelvic nodal radiotherapy on top.

## Sources

- ClinicalTrials.gov NCT00541047: https://clinicaltrials.gov/study/NCT00541047
- ISRCTN registry ISRCTN40814031: https://www.isrctn.com/ISRCTN40814031
- RADICALS-HD (Lancet 2024): https://doi.org/10.1016/S0140-6736(24)00549-X

## Connected records

- cancers: [Biochemical recurrence of prostate cancer](https://onco.cc/cancers/prostate-bcr/), [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: [Bicalutamide](https://onco.cc/drugs/bicalutamide/), [Degarelix](https://onco.cc/drugs/degarelix/)
- companies: [MRC Clinical Trials Unit at UCL](https://onco.cc/companies/mrc-ctu/)
- institutions: [University College London Hospitals / UCL Cancer Institute](https://onco.cc/institutions/uclh/)
- terms: [Androgen deprivation therapy (ADT)](https://onco.cc/terms/adt/), [Hormone therapy](https://onco.cc/terms/hormone-therapy/), [Radical prostatectomy](https://onco.cc/terms/prostatectomy/), [Salvage therapy](https://onco.cc/terms/salvage-therapy/), [What androgen deprivation costs: the side of hormone therapy the survival curves do not show](https://onco.cc/terms/prostate-adt-burden/)
- trials: [EMBARK](https://onco.cc/trials/embark/), [GETUG-AFU 16](https://onco.cc/trials/getug-afu-16/), [Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer](https://onco.cc/trials/nct00567580/), [RADICALS-RT](https://onco.cc/trials/radicals-rt/)

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