PURPOSE: To perform a randomized trial comparing 70 and 80 Gy radiotherapy for prostate cancer. PATIENTS AND METHODS: A total of 306 patients with localized prostate cancer were randomized. No androgen deprivation was allowed. The primary endpoint was biochemical relapse according to the modified 1997-American Society for Therapeutic Radiology and Oncology and Phoenix definitions. Toxicity was graded using the Radiation Therapy Oncology Group 1991 criteria and the late effects on normal tissues-subjective, objective, management, analytic scales (LENT-SOMA) scales. The patients' quality of life was scored using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item cancer-specific and 25-item prostate-specific modules. RESULTS: The median follow-up was 61 months. According to the 1997-American Society for Therapeutic Radiology and Oncology definition, the 5-year biochemical relapse rate was 39% and 28% in the 70- and 80-Gy arms, respectively (p = .036). Using the Phoenix definition, the 5-year biochemical relapse rate was 32% and 23.5%, respectively (p = .09). The subgroup analysis showed a better biochemical outcome for the higher dose group with an initial prostate-specific antigen level >15 ng/mL. At the last follow-up date, 26 patients had died, 10 of their disease and none of toxicity, with no differences between the two arms. According to the Radiation Therapy Oncology Group scale, the Grade 2 or greater rectal toxicity rate was 14% and 19.5% for the 70- and 80-Gy arms (p = .22), respectively. The Grade 2 or greater urinary toxicity was 10% at 70 Gy and 17.5% at 80 Gy (p = .046). Similar results were observed using the LENT-SOMA scale. Bladder toxicity was more frequent at 80 Gy than at 70 Gy (p = .039). The quality-of-life questionnaire results before and 5 years after treatment were available for 103 patients with no differences found between the 70- and 80-Gy arms. CONCLUSION:High-dose radiotherapy provided a better 5-year biochemical outcome with slightly greater toxicity.
RCT Entities:
PURPOSE: To perform a randomized trial comparing 70 and 80 Gy radiotherapy for prostate cancer. PATIENTS AND METHODS: A total of 306 patients with localized prostate cancer were randomized. No androgen deprivation was allowed. The primary endpoint was biochemical relapse according to the modified 1997-American Society for Therapeutic Radiology and Oncology and Phoenix definitions. Toxicity was graded using the Radiation Therapy Oncology Group 1991 criteria and the late effects on normal tissues-subjective, objective, management, analytic scales (LENT-SOMA) scales. The patients' quality of life was scored using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item cancer-specific and 25-item prostate-specific modules. RESULTS: The median follow-up was 61 months. According to the 1997-American Society for Therapeutic Radiology and Oncology definition, the 5-year biochemical relapse rate was 39% and 28% in the 70- and 80-Gy arms, respectively (p = .036). Using the Phoenix definition, the 5-year biochemical relapse rate was 32% and 23.5%, respectively (p = .09). The subgroup analysis showed a better biochemical outcome for the higher dose group with an initial prostate-specific antigen level >15 ng/mL. At the last follow-up date, 26 patients had died, 10 of their disease and none of toxicity, with no differences between the two arms. According to the Radiation Therapy Oncology Group scale, the Grade 2 or greater rectal toxicity rate was 14% and 19.5% for the 70- and 80-Gy arms (p = .22), respectively. The Grade 2 or greater urinary toxicity was 10% at 70 Gy and 17.5% at 80 Gy (p = .046). Similar results were observed using the LENT-SOMA scale. Bladder toxicity was more frequent at 80 Gy than at 70 Gy (p = .039). The quality-of-life questionnaire results before and 5 years after treatment were available for 103 patients with no differences found between the 70- and 80-Gy arms. CONCLUSION: High-dose radiotherapy provided a better 5-year biochemical outcome with slightly greater toxicity.
Authors: Romain Mathieu; Juan David Ospina Arango; Véronique Beckendorf; Jean-Bernard Delobel; Taha Messai; Ciprian Chira; Alberto Bossi; Elisabeth Le Prisé; Stéphane Guerif; Jean-Marc Simon; Bernard Dubray; Jian Zhu; Jean-Léon Lagrange; Pascal Pommier; Khemara Gnep; Oscar Acosta; Renaud De Crevoisier Journal: World J Urol Date: 2013-08-29 Impact factor: 4.226
Authors: Tomasz Barelkowski; Peter Wust; David Kaul; Sebastian Zschaeck; Waldemar Wlodarczyk; Volker Budach; Pirus Ghadjar; Marcus Beck Journal: Strahlenther Onkol Date: 2019-12-23 Impact factor: 3.621
Authors: Deborah W Bruner; Daniel Hunt; Jeff M Michalski; Walter R Bosch; James M Galvin; Mahul Amin; Canhua Xiao; Jean-Paul Bahary; Malti Patel; Susan Chafe; George Rodrigues; Harold Lau; Marie Duclos; Madhava Baikadi; Snehal Deshmukh; Howard M Sandler Journal: Cancer Date: 2015-04-02 Impact factor: 6.860
Authors: Jeff M Michalski; Jennifer Moughan; James Purdy; Walter Bosch; Deborah W Bruner; Jean-Paul Bahary; Harold Lau; Marie Duclos; Matthew Parliament; Gerard Morton; Daniel Hamstra; Michael Seider; Michael I Lock; Malti Patel; Hiram Gay; Eric Vigneault; Kathryn Winter; Howard Sandler Journal: JAMA Oncol Date: 2018-06-14 Impact factor: 31.777
Authors: Pirus Ghadjar; Andrew Jackson; Daniel E Spratt; Jung Hun Oh; Per Munck af Rosenschöld; Marisa Kollmeier; Ellen Yorke; Margie Hunt; Joseph O Deasy; Michael J Zelefsky Journal: Eur Urol Date: 2013-02-14 Impact factor: 20.096
Authors: Oscar Acosta; Gael Drean; Juan D Ospina; Antoine Simon; Pascal Haigron; Caroline Lafond; Renaud de Crevoisier Journal: Phys Med Biol Date: 2013-03-26 Impact factor: 3.609
Authors: Berardino De Bari; Filippo Alongi; Pierfrancesco Franco; Patrizia Ciammella; Tarik Chekrine; Lorenzo Livi; Barbara A Jereczek-Fossa; Andrea Riccardo Filippi Journal: Radiol Med Date: 2013-05-27 Impact factor: 3.469