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Long-Term versus Short-Term Androgen Deprivation Combined with High-Dose Radiotherapy for Intermediate and High Risk Prostate Cancer: Preliminary Results of a Phase III Randomized Trial - DART 01/05

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Background

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  1. Long-Term versus Short-Term Androgen Deprivation Combined with High-Dose Radiotherapy for Intermediate and High Risk Prostate Cancer: Preliminary Results of a Phase III Randomized Trial - DART 01/05 A.Zapatero, A.Guerrero, X.Maldonado, A.Alvarez, C.González Sansegundo, A.Cabeza, V.Macías, F.Casas. A. Pedro-Olivé, S.Villa, A.Boladeras, M.L. Vazquez de la Torre, C. Martin de Vidales, F.A.Calvo.G.I.C.O.R. This study has been supported by Governmental Grant No. 04/2506 fron the FIS (National Health Investigation Fund – Fondo de Investigación Sanitaria)

  2. Background • In locallyadvancedprostatecancer, randomizedtrialshaveshown a significantbenefit in OS whenandrogendeprivation (AD) and conventionaldose of radiotherapy (≤ 70-72 Gy) are associated. • A GICOR study (JCO, 2005) showed and independentbenefit of doseescalationcombinedwith AD in high-riskdisease. • The role and theoptimalscheme of AD whenassociatedtohigh-doseradiotherapyremains controversial.

  3. Objectives / Purpose To determine whether long-term AD (LTAD) is superior to short -term AD (STAD) in intermediate and high-risk prostate cancer patients treated with high-dose RT. • Primary endpoint: Freedom from biochemical failure (FFBF). (Phoenix definition) • Secondary endpoints: Freedom from clinical failure (FFCF) Overall survival (OS) Toxicity (RTOG and CTC criteria)

  4. -Study designed to detect a difference in FFBF of 15% in favor of LTAD with a statistical power of 80% and a unilateral significance level of 5%. -Sample size required including 15% loss: 358 patients

  5. Limitations of the study • This study assumes the inherent limitations of an interim analysis report: • Short follow-up • Short number of events • Absence of a control arm with HDRT alone ? • FFBF less than optimal primary endpoint? • Strenght of the study • This is a pioneering study to evaluate the role of AD combined with high-dose escalated RT (median 78 Gy) in prostate cancer.

  6. Conclusion • Although preliminary, the results of the study suggest that LTAD could be superior to STAD in patients with unfavorable prostate cancer treated with high-dose external beam radiotherapy. • Relevant radiation toxicity remains acceptably low and not significantly different in both treatment arms. • Longer follow-up is required to confirm these trends.

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