{"entity":{"id":"dart-01-05-gicor","kind":"trial","name":"DART 01/05 GICOR","aka":["DART01/05","DART 01/05 GICOR"],"tldr":"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.\n\nAt 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.\n\nLate 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.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02175212","url":"https://clinicaltrials.gov/study/NCT02175212"},{"label":"DART 01/05 GICOR (Lancet Oncology 2015)","url":"https://doi.org/10.1016/S1470-2045(15)70045-8"}],"tags":[],"related":[],"cancers":["prostate","prostate-intermediate-risk","prostate-high-risk"],"sections":[],"technologies":["androgen-deprivation","imrt-igrt"],"targets":[],"drugs":["goserelin","flutamide","bicalutamide"],"companies":[],"institutions":[],"pathways":[],"terms":["adt","hormone-therapy","curative-intent"],"trials":["rtog-9202","eortc-22961","eortc-22991"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"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","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.","yearReported":2015,"enrolled":355,"enrolledBasis":"randomised","enrolledNote":"355 men were randomised between November 2005 and December 2010, 178 to short-course and 177 to long-course androgen deprivation.","outcomes":[{"endpoint":"Biochemical disease-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Long-course androgen deprivation, 28 months total","n":177,"value":90,"note":"Hazard ratio is for failure with short-course treatment."},{"name":"Short-course androgen deprivation, 4 months","n":178,"value":81}],"hr":1.88,"ci":[1.12,3.15],"p":"0.01","source":"https://doi.org/10.1016/S1470-2045(15)70045-8"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Long-course androgen deprivation, 28 months total","n":177,"value":95},{"name":"Short-course androgen deprivation, 4 months","n":178,"value":86}],"hr":2.48,"ci":[1.31,4.68],"p":"0.009","source":"https://doi.org/10.1016/S1470-2045(15)70045-8"}],"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."},"route":"/trials/dart-01-05-gicor/","neighbours":{"cancer":[{"id":"prostate-high-risk","kind":"cancer","name":"Localised prostate cancer, high and very high risk","route":"/cancers/prostate-high-risk/"},{"id":"prostate-intermediate-risk","kind":"cancer","name":"Localised prostate cancer, intermediate risk","route":"/cancers/prostate-intermediate-risk/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"androgen-deprivation","kind":"technology","name":"Androgen deprivation & AR pathway inhibitors","route":"/technologies/androgen-deprivation/"},{"id":"imrt-igrt","kind":"technology","name":"IMRT / IGRT (modern external beam)","route":"/technologies/imrt-igrt/"}],"drug":[{"id":"bicalutamide","kind":"drug","name":"Bicalutamide","route":"/drugs/bicalutamide/"},{"id":"flutamide","kind":"drug","name":"Flutamide","route":"/drugs/flutamide/"},{"id":"goserelin","kind":"drug","name":"Goserelin / leuprolide (ovarian function suppression)","route":"/drugs/goserelin/"}],"term":[{"id":"adt","kind":"term","name":"Androgen deprivation therapy (ADT)","route":"/terms/adt/"},{"id":"curative-intent","kind":"term","name":"Curative intent vs palliative intent","route":"/terms/curative-intent/"},{"id":"hormone-therapy","kind":"term","name":"Hormone therapy","route":"/terms/hormone-therapy/"},{"id":"prostate-adt-burden","kind":"term","name":"What androgen deprivation costs: the side of hormone therapy the survival curves do not show","route":"/terms/prostate-adt-burden/"}],"trial":[{"id":"eortc-22961","kind":"trial","name":"EORTC 22961","route":"/trials/eortc-22961/"},{"id":"eortc-22991","kind":"trial","name":"EORTC 22991","route":"/trials/eortc-22991/"},{"id":"rtog-9202","kind":"trial","name":"RTOG 92-02","route":"/trials/rtog-9202/"}]}}