# DART 01/05 GICOR

Source: https://onco.cc/trials/dart-01-05-gicor/  
OnCo record `dart-01-05-gicor` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Even when the radiation dose is pushed high, two more years of hormone therapy still improves survival for men with high-risk prostate cancer.

## Summary

DART 01/05 GICOR tested whether escalating the radiation dose removes the need for long androgen deprivation. It randomised 355 men at ten Spanish university hospitals to 4 months of neoadjuvant and concomitant androgen deprivation with high-dose three-dimensional conformal radiotherapy of at least 76 Gy (range 76 to 82 Gy), or the same followed by 24 months of adjuvant androgen deprivation. Anti-androgen therapy, flutamide 750 mg or bicalutamide 50 mg daily, was added during the first 2 months.

At a median 63 months, 5-year biochemical disease-free survival was 90 percent (95 percent confidence interval 87 to 92) with long-course treatment against 81 percent (78 to 85) with short-course, hazard ratio 1.88 (1.12 to 3.15, p=0.01). Five-year overall survival was 95 percent (93 to 97) against 86 percent (83 to 89), hazard ratio 2.48 (1.31 to 4.68, p=0.009), and 5-year metastasis-free survival 94 percent (92 to 96) against 83 percent (80 to 86), hazard ratio 2.31 (1.23 to 3.85, p=0.01). The effect was more evident in high-risk than in lower-risk men.

Late toxicity did not differ: grade 3 late rectal toxicity in three of 177 long-course and two of 178 short-course men, grade 3 to 4 late urinary toxicity in five men in each group, and no treatment-related deaths. The authors were explicit that longer follow-up is needed before concluding that intermediate-risk men benefit from more than 4 months.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-25
- Also known as: DART01/05; DART 01/05 GICOR
- Registry id: NCT02175212
- Phase: 3
- Setting: Clinical stage T1c to T3b N0 M0 prostate adenocarcinoma with intermediate-risk or high-risk factors: 4 months of androgen deprivation with high-dose three-dimensional conformal radiotherapy of at least 76 Gy, with or without 24 further months of adjuvant androgen deprivation, with biochemical disease-free survival as the primary endpoint
- Sponsor: Grupo de Investigacion Clinica en Oncologia Radioterapica (GICOR), Spain
- Enrolled: 355
- Result: Five-year overall survival 95 against 86 percent (hazard ratio 2.48, 95 percent confidence interval 1.31 to 4.68) and biochemical disease-free survival 90 against 81 percent (1.88, 1.12 to 3.15) with 24 extra months of androgen deprivation after high-dose radiotherapy.
- Outcomes: Biochemical disease-free survival at 5 years: Long-course androgen deprivation, 28 months total 90% vs Short-course androgen deprivation, 4 months 81%, HR 1.88; Overall survival at 5 years: Long-course androgen deprivation, 28 months total 95% vs Short-course androgen deprivation, 4 months 86%, HR 2.48
- Replication: Consistent with RTOG 92-02 and EORTC 22961, both of which found long-course androgen deprivation better, and both of which used lower radiation doses.

## Sources

- ClinicalTrials.gov NCT02175212: https://clinicaltrials.gov/study/NCT02175212
- DART 01/05 GICOR (Lancet Oncology 2015): https://doi.org/10.1016/S1470-2045(15)70045-8

## Connected records

- cancers: [Localised prostate cancer, high and very high risk](https://onco.cc/cancers/prostate-high-risk/), [Localised prostate cancer, intermediate risk](https://onco.cc/cancers/prostate-intermediate-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/), [Flutamide](https://onco.cc/drugs/flutamide/), [Goserelin / leuprolide (ovarian function suppression)](https://onco.cc/drugs/goserelin/)
- 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/), [What androgen deprivation costs: the side of hormone therapy the survival curves do not show](https://onco.cc/terms/prostate-adt-burden/)
- trials: [EORTC 22961](https://onco.cc/trials/eortc-22961/), [EORTC 22991](https://onco.cc/trials/eortc-22991/), [RTOG 92-02](https://onco.cc/trials/rtog-9202/)

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