Does short-term androgen depletion add to high dose radiotherapy (80 Gy) in localized intermediate risk prostate cancer? Final analysis of GETUG 14 randomized trial (EU-20503/NCT00104741).

Authors

null

Bernard M. Dubray

CRLCC Henri Becquerel, Rouen, France

Bernard M. Dubray , Julia Salleron , Stephane Gilles Guerif , Elisabeth Le Prise , Agnes Reynaud-Bougnoux , Jean-Michel Hannoun-Levi , Tan Dat Nguyen , Christophe Hennequin , Jacques Cretin , Maryse Fayolle-Campana , Jean-Leon Lagrange , Jean-Marc Bachaud , David Azria , Alain Grangirard , Pascal Pommier , Jean-Marc Simon , Muriel Habibian , Pierre Bey , Veronique Beckendorf

Organizations

CRLCC Henri Becquerel, Rouen, France, Institut de Cancérologie de Lorraine, Nancy, France, University Hospital of Poitiers, Poitiers, France, Centre Eugene Marquis, Rennes, France, CHU Bretonneau, Tours, France, Centre Antoine-Lacassagne, Nice, France, Institut Jean-Godinot, Reims, France, Dept of Radiation Oncology, Hôpital Saint-Louis, Paris, France, Clinique Valdegour, Nimes, France, HIA Val de Grace, Paris, France, CHU Henri Mondor, Creteil, France, CRLCC Claudius Regaud, Toulouse, France, Institut Régional du Cancer, Montpellier, France, Hopital du Hasenrain, Mulhouse, France, CRLCC Léon Bérard, Lyon, France, CHU Pitie-Salpetriere, Paris, France, UNICANCER, Paris, France, Institut de Cancérologie de Lorraine, Vandoeuvre-Lès-Nancy, France

Research Funding

Other

Background: Multi-center randomized trial to evaluate the addition of 4-month androgen deprivation to high dose radiotherapy in intermediate risk localized prostate adenocarcinoma patients (pts). Methods: eligible pts were randomly assigned to high dose conformal radiotherapy (prostate 80 Gy / 40 fractions; seminal vesicles 46 Gy / 23 fractions) either alone (group RT) or in combination with 4-month androgen deprivation (flutamide + triptorelin starting 2 months before radiotherapy, group AD-RT). Lymphadenectomy was mandatory when the risk of node involvement was > 10% (Partin). The primary endpoint was survival without clinical / biochemical relapse at 5 years. Secondary endpoints included overall survival, toxicity (CTCAE v3) and quality of life (QLQ-C30, PR-25). The a-priori sample size was 450 patients, 225 per arm (0.90 power to detect an increase from 75 to 85%, bilateral α = 0.05). Results: 377 pts were included between September 2003 and June 2010. The inclusions were prematurely closed, due to slow accrual. Intent-to-treat analysis was made for 370 pts (191 RT, 179 AD-RT). Prognostic factors were well balanced between the two arms. The median follow-up duration was 84 months (range: 3 to 132). At 5 years, the probabilities of survival without clinical / biochemical relapse were 76% [95% CI: 69% – 81%] and 84% [78% – 89%] in RT and AD-RT groups, respectively (p = 0.02). Overall survival probabilities were 94% [90% - 97%] and 93% [88% - 96%] respectively (p = 0.54).Cumulative incidence of biochemical failure were 21% [15% – 26%] and 10% [6% – 15%], respectively (p < 0.01). The probabilities of being free of grade 3-4 toxicities were 96% and 95% (p = 0.69) for digestive tract, 93% and 95% (p = 0.44) for urinary tract. Conclusions: 4 months of androgen blockade improves event-free survival at 5 years in pts with intermediate risk prostate adenocarcinoma when treated with high dose radiotherapy. Longer follow-up is required to demonstrate an impact on overall survival. Clinical trial information: EU-20503 / NCT00104741.

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Abstract Details

Meeting

2016 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Genitourinary (Prostate) Cancer

Track

Genitourinary Cancer—Prostate, Testicular, and Penile

Sub Track

Prostate Cancer–Local-Regional Disease

Clinical Trial Registration Number

EU-20503 / NCT00104741

Citation

J Clin Oncol 34, 2016 (suppl; abstr 5021)

DOI

10.1200/JCO.2016.34.15_suppl.5021

Abstract #

5021

Poster Bd #

278

Abstract Disclosures