International Journal of Radiation Oncology * Biology * Physics
Volume 78, Issue 1 , Pages 11-18 , 1 September 2010

A Prospective Phase III Randomized Trial of Hypofractionation Versus Conventional Fractionation in Patients With High-Risk Prostate Cancer

  • Giorgio Arcangeli, M.D.

      Affiliations

    • Department of Radiotherapy, Regina Elena National Cancer Institute, Rome, Italy
    • Corresponding Author InformationAddress reprint requests to: Arcangeli Giorgio, M.D., Department of Radiotherapy, Regina Elena Cancer Institute, via Elio Chianesi 53, 00144 Rome, Italy. Tel: (+39) 06-52666131; Fax: (+39) 06-52665667
    • ,
  • Biancamaria Saracino, M.D.

      Affiliations

    • Department of Radiotherapy, Regina Elena National Cancer Institute, Rome, Italy
    • ,
  • Sara Gomellini, M.D.

      Affiliations

    • Department of Radiotherapy, Regina Elena National Cancer Institute, Rome, Italy
    • ,
  • Maria Grazia Petrongari, M.D.

      Affiliations

    • Department of Radiotherapy, Regina Elena National Cancer Institute, Rome, Italy
    • ,
  • Stefano Arcangeli, M.D.

      Affiliations

    • Department of Radiotherapy, Regina Elena National Cancer Institute, Rome, Italy
    • ,
  • Steno Sentinelli, M.D.

      Affiliations

    • Department of Pathology, Regina Elena National Cancer Institute, Rome, Italy
    • ,
  • Simona Marzi, Ph.D.

      Affiliations

    • Laboratory of Medical Physics and Expert System, Regina Elena National Cancer Institute, Rome, Italy
    • ,
  • Valeria Landoni, Ph.D.

      Affiliations

    • Laboratory of Medical Physics and Expert System, Regina Elena National Cancer Institute, Rome, Italy
    • ,
  • Jack Fowler, D.Sc., Ph.D.

      Affiliations

    • Emeritus Departments of Human Oncology and Medical Physics, Medical School of the University of Wisconsin, Madison, WI
    • ,
  • Lidia Strigari, Ph.D.

      Affiliations

    • Laboratory of Medical Physics and Expert System, Regina Elena National Cancer Institute, Rome, Italy

Received 8 May 2009 ,Revised 1 July 2009 ,Accepted 15 July 2009.

References 

  1. Pollack A, Zagars GK, Starkschall G, et al. Prostate cancer radiation dose response: Results of the M.D. Anderson Phase III randomized trial. Int J Radiat Oncol Biol Phys. 2002;53:1097–1105
  2. Peeters STH, Heemsbergen WD, Koper PCM, et al. Dose-response in radiotherapy for localized prostate cancer: Results of the Dutch multicenter randomized Phase III trial comparing 68 Gy of radiotherapy with 78 Gy. J Clin Oncol. 2006;24:1990–1996
  3. Fowler J, Chappel R, Ritter M. Is alpha/beta for prostate tumors really low?. Int J Radiat Oncol Biol Phys. 2001;50:1021–1031
  4. Brenner DJ, Martinez AA, Edmundson GK, et al. Direct evidence that prostate tumors shows high sensitivity to fractionation (low alpha/beta ratio), similar to late-responding normal tissue. Int J Radiat Oncol Biol Phys. 2002;52:6–13
  5. Williams SG, Taylor JM, Liu N, et al. Use of individual fraction size data from 3756 patients to directly determine the alpha/beta ratio of prostate cancer. Int J Radiat Oncol Biol Phys. 2007;68:24–33
  6. Steel GG. Basic clinical radiobiology. London: Arnold; 2003;
  7. Kupelian PA, Willoughby TR, Reddy CA. Hypofractionated intensity-modulated radiotherapy (70 Gy at 2.5 Gy per fraction) for localized prostate cancer. Cleveland Clinic experience. Int J Radiat Oncol Biol Phys. 2007;63:1424–1430
  8. Soete G, Arcangeli S, De Meerleer G, et al. Phase II study of a four week hypofractionated external beam radiotherapy regimen for prostate cancer: report on acute toxicity. Radiother Oncol. 2006;80:78–81
  9. Madsen BL, His RA, Pham HT, et al. Stereotactic hypofractionated accurate radiotherapy of the prostate (SHARP), 33.4 Gy in five fractions for localized disease: First clinical trial results. Int J Radiat Oncol Biol Phys. 2007;67:1099–1105
  10. Lukka H, Hayter C, Julian JA, et al. A randomized trial comparing two fractionation schedules for patients with localized prostate cancer. J Clin Oncol. 2005;23:6132–6138
  11. Yeoh EE, Holloway RH, Fraser RJ, et al. Hypofractionated versus conventionally fractionated radiation therapy for prostate carcinoma: Updated results of a Phase III randomized trial. Int J Radiat Oncol Biol Phys. 2006;66:1072–1083
  12. Feigensberger SJ, Hanlon AL, Horwitz EM, et al. Long-term androgen deprivation increases Grade 2 and higher late morbidity in prostate cancer patients treated with three-dimensional conformal radiation therapy. Int J Radiat Oncol Biol Phys. 2005;62:397–405
  13. Huang EH, Pollack A, Levy L, et al. Late rectal toxicity: Dose–volume effects of conformal radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2002;54:1314–1321
  14. Burman C, Kutcher GJ, Emami B, et al. Fitting of normal tissue tolerance data to analytic function. Int J Radiat Oncol Biol Phys. 1991;21:123–135
  15. Cox JD, Stetz J, Pajak TF. Toxicity criteria of the Radiation Therapy Oncology group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys. 1995;31:1341–1346
  16. Barry MJ, Fowler FJ, O'Leary MP, et al. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992;148:1549–1557
  17. Pavy JJ, Denekamp J, Letschert J, et al. Late effects toxicity scoring: The SOMA scale. Int J Radiat Oncol Biol Phys. 1995;31:1043–1049
  18. Roach M, Hanks G, Thames H, et al. Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO Phoenix Consensus Conference. Int J Radiat Oncol Biol Phys. 2006;65:965–974
  19. Sanguineti G, Agostinelli S, Foppiano F, et al. Adjuvant androgen deprivation impacts late rectal toxicity after conformal radiotherapy of prostate carcinoma. Br J Cancer. 2002;86:1843–1847
  20. Strigari L, Arcangeli G, Arcangeli S, Benassi M. Mathematical model for evaluating incidence of acute rectal toxicity during conventional or hypofractionated radiotherapy courses for prostate cancer. Int J Radiat Oncol Biol Phys. 2009;73:1454–1460
  21. Zelefski MJ, Yamada Y, Fuks Z, et al. Long-term results of conformal radiotherapy for prostate cancer: Impact of dose escalation on biochemical tumor control and distant metastases-free survival. Int J Radiat Oncol Biol Phys. 2008;71:1028–1033
  22. Bentzen SM, Ritter MA. The α/β ratio for prostate cancer: What is it, really?. Radiother Oncol. 2005;76:1–3
  23. Joon DL, Hasegawa M, Sikes C, et al. Supraadditive apoptotic response of R3327-G rat prostate tumors to androgen ablation and radiation. Int J Radiat Oncol Biol Phys. 1997;38:1071–1077

 Conflict of interest: none.

PII: S0360-3016(09)02795-3

doi: 10.1016/j.ijrobp.2009.07.1691

International Journal of Radiation Oncology * Biology * Physics
Volume 78, Issue 1 , Pages 11-18 , 1 September 2010

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