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

Authors

null

B. M. Dubray

CRLCC Henri Becquerel, Rouen, France

B. M. Dubray , V. Beckendorf , S. Guerif , E. Le Prise , A. Reynaud-Bougnoux , J. M. Hannoun Levi , T. D. Nguyen , C. Hennequin , J. Cretin , M. Fayolle-Campana , J. Lagrange , J. Bachaud , D. Azria , A. Grangirard , P. Pommier , J. Simon , V. Harter , M. Habibian

Organizations

CRLCC Henri Becquerel, Rouen, France, CRLCC Alexis Vautrin, Vandoeuvre Les Nancy, France, CHU La Miletrie, Poitiers, France, CRLCC Eugene Marquis, Rennes, France, Centre Henry S. Kaplan, Tours, France, CRLCC Antoine-Lacassagne, Nice, France, Institut Jean Godinot, Reims, France, CHU St-Louis, Paris, France, Clinique de Valdegour, Nimes, France, HIA Val de Grace, Paris, France, CHU Henri Mondor, Creteil, France, CRLCC Claudius Regaud, Toulouse, France, CRLCC Val d'Aurelle, Montpellier, France, Hopital du Hasenrain, Mulhouse, France, CRLCC Leon Berard, Lyon, France, CHU Pitie-Salpetriere, Paris, France, Federation Nationale des Centres de Lutte Contre le Cancer, Paris, France

Research Funding

Other

Background: randomized trial to evaluate the addition of 4-month androgen deprivation to high dose radiotherapy in localized intermediate risk prostate adenocarcinoma patients. Methods: eligible patients were randomly assigned to high dose radiotherapy (prostate 80 Gy; seminal vesicles 46 Gy) either alone (group RT) or in combination with 4-month androgen deprivation (flutamide + triptoreline starting 2 months before radiotherapy, group AD-RT). Lymphadenectomy was mandatory when the risk of node involvement was > 10% (Partin). The primary endpoint was biochemical (Phoenix definition) or clinical control. Secondary endpoints included survival, toxicity (CTCAE v3) and quality of life. The a-priori sample size was 450 patients (0.90 power to detect an increase from 75 to 85%, bilateral α = 0.05). An intermediate analysis was planned 6 months after the last patient inclusion (bilateral α = 0.005). Results: 377 patients were entered between October 2003 and July 2010. The trial was prematurely closed, due to slow accrual. Intention-to-treat analysis included 366 patients (188 RT, 178 AD-RT). Prognostic factors were well balanced between groups. The median follow-up duration was 37 months (range: 0 to 63). At 3 years, biochemical or clinical control probabilities were 86% [95% CI: 80%–92%] and 92% [87%–97%] in RT and AD-RT groups respectively (p = 0.09). Biochemical control probabilities were 91% [86%–96%] and 97% [94%–99.6%] in RT and AD-RT groups respectively (p = 0.04). The cumulative hazards of grade 3-4 toxicities were 6.4% and 2.8% (p=0.41) for digestive tract, 2.6% and 6.1% (p=0.14) for urinary tract, in RT and AD-RT groups respectively. Conclusions: The observed difference in favour of AD-RT did not reach statistical significance as defined for the present intermediary analysis. The final analysis is scheduled in 2013.

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Abstract Details

Meeting

2011 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Genitourinary (Prostate) Cancer

Track

Genitourinary Cancer

Sub Track

Prostate Cancer

Clinical Trial Registration Number

NCT00104741

Citation

J Clin Oncol 29: 2011 (suppl; abstr 4521)

Abstract #

4521

Poster Bd #

1

Abstract Disclosures

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