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Is There a Role for Pelvic Irradiation in Localized Prostate Adenocarcinoma? Preliminary Results of GETUG-01

Pascal Pommier, Sylvie Chabaud, Jean Leon Lagrange, Pierre Richaud, François Lesaunier, Elisabeth Le Prise, Jean Philippe Wagner, Meng Huor Hay, Veronique Beckendorf, Jean Philippe Suchaud, Pierre Marie Pabot du Chatelard, Valerie Bernier, Nicolas Voirin, David Perol, Christian Carrie

From the Centre Léon Bérard, Lyon; Hopital Henri Mondor, Creteil; Insitute Bergonie, Bordeaux; Centre Francois Baclesse, Caen; Centre Eugene Marquis, Rennes; Clinique de L'Orangerie, Strasbourg; Centre Val d'Aurelle, Montpellier; Centre Alexis Vautrin, Nancy; Hopital de Roanne, Roanne; and Centre Paul Papin, Angers, France

Address reprint requests to Pascal Pommier, MD, Centre Léon Bérard, Department of Radiotherapy, 28 rue Laennec, Lyon, 69008 France; e-mail: pommier{at}lyon.fnclcc.fr

Purpose To assess the benefit and toxicity and quality-of-life (QOL) outcomes of pelvic nodes irradiation in nonmetastatic prostate carcinoma patients.

Patients and Methods Between December 1998 and June 2004, 444 patients with T1b-T3, N0 pNx, M0 prostate carcinoma were randomly assigned to either pelvic and prostate radiotherapy or prostate radiotherapy only. Patients were stratified according to the prognostic factor of lymph node involvement (LNI). Short-term 6-month neoadjuvant and concomitant hormonal therapy was allowed only for patients in the high-risk group. The pelvic dose was 46 Gy. The total dose recommended to the prostate was changed during the course of the study from 66 Gy to 70 Gy. Criteria for progression-free survival (PFS) included biologic prostate-specific antigen recurrences or a local or metastatic evolution. Acute and late toxicities were recorded according to the Radiation Therapy Oncology Group and Late Effects in Normal Tissues Subjective, Objective, Management, and Analytic scales, respectively. The QOL outcome was recorded with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30, the International Prostatic Symptom Score, and the Sexual Function Index scales.

Results With a 42.1-month median follow-up time, the 5-year PFS and overall survival were similar in the two treatment arms for the whole series and for each stratified group. On multivariate analysis, low LNI risk and hormonal therapy were statistically associated with increased PFS. However, subgroup analyses based on these factors did not show any benefit for pelvic irradiation. There were no significant differences in acute and late digestive toxicities and in QOL outcomes.

Conclusion Pelvic node irradiation was well tolerated but did not improve PFS.

Supported by the Groupe d'Etude des Tumeurs Uro-Genitales (French Genitourinary Group) of the Fédération Nationale des Centres de Lutte Contre le Cancer, with a grant from the Ligue Nationale Contre le Cancer.

Presented in part at the 47th Annual Meeting of the American Society for Therapeutic Radiology and Oncology, October 16-20, 2005, Denver, CO (Pommier P, Perol D, Lagrange J, et al: Does pelvis and prostate radiation therapy compared to prostate radiation therapy alone improve survival in patients with non metastatic prostate carcinoma? Preliminary results of the prospective randomized GETUG01 trial. Int J Radiat Oncol Biol Phys 63:S19-S20, 2005).

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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