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| ID | Type | Description | Link |
|---|---|---|---|
| IRB201701768 | Other Identifier | University of Florida |
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The purpose of this trial is to give a shorter course (5 ½-6 weeks) of proton radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of proton radiation, without decreasing the chance of killing prostate cancer cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Risk | Experimental | 70 Gy/CGE |
|
| Intermediate Risk | Experimental | 72.5 Gy/CGE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 70 Gy/CGE | Radiation | Low Risk |
| |
| 72.5 Gy/CGE |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of treatment-related grade 2 or higher rectal bleeding. | 2 years after completion of radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Analyzation of quality of life | After radiation: every 6 months for 3 years, then annually for 20 years | |
| Analysis of treatment-related morbidity | Cumulative incidence up to 20 years after completion of radiation therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Curtis Bryant, MD, MPH | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Proton Therapy Institute | Jacksonville | Florida | 32209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | American Cancer Society. 2010. Ref Type: Electronic Citation | ||
| 11743286 | Background | Soloway MS, Pareek K, Sharifi R, Wajsman Z, McLeod D, Wood DP Jr, Puras-Baez A; Lupron Depot Neoadjuvant Prostate Cancer Study Group. Neoadjuvant androgen ablation before radical prostatectomy in cT2bNxMo prostate cancer: 5-year results. J Urol. 2002 Jan;167(1):112-6. | |
| 11792912 |
| Label | URL |
|---|---|
| (Contact the University of Florida Proton Therapy Institute) | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Radiation |
Intermediate Risk |
|
| Analysis of disease control | Proportion of patients with disease control after completion of treatment | Cumulative incidence up to 20 years after completion of radiation therapy |
| Analysis of overall survival | Proportion of patients alive after completion of treatment | Cumulative incidence up to 20 years after completion of radiation therapy |
| Background |
| Hull GW, Rabbani F, Abbas F, Wheeler TM, Kattan MW, Scardino PT. Cancer control with radical prostatectomy alone in 1,000 consecutive patients. J Urol. 2002 Feb;167(2 Pt 1):528-34. doi: 10.1016/S0022-5347(01)69079-7. |
| 10920135 | Background | Kestin LL, Martinez AA, Stromberg JS, Edmundson GK, Gustafson GS, Brabbins DS, Chen PY, Vicini FA. Matched-pair analysis of conformal high-dose-rate brachytherapy boost versus external-beam radiation therapy alone for locally advanced prostate cancer. J Clin Oncol. 2000 Aug;18(15):2869-80. doi: 10.1200/JCO.2000.18.15.2869. |
| 16053667 | Background | Merrick GS, Butler WM, Wallner KE, Galbreath RW, Allen ZA, Adamovich E. The impact of primary Gleason grade on biochemical outcome following brachytherapy for hormone-naive Gleason score 7 prostate cancer. Cancer J. 2005 May-Jun;11(3):234-40. doi: 10.1097/00130404-200505000-00010. |
| 15817332 | Background | Demanes DJ, Rodriguez RR, Schour L, Brandt D, Altieri G. High-dose-rate intensity-modulated brachytherapy with external beam radiotherapy for prostate cancer: California endocurietherapy's 10-year results. Int J Radiat Oncol Biol Phys. 2005 Apr 1;61(5):1306-16. doi: 10.1016/j.ijrobp.2004.08.014. |
| 9749478 | Background | D'Amico AV, Whittington R, Malkowicz SB, Schultz D, Blank K, Broderick GA, Tomaszewski JE, Renshaw AA, Kaplan I, Beard CJ, Wein A. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998 Sep 16;280(11):969-74. doi: 10.1001/jama.280.11.969. |
| Background | Common Terminology Criteria for Adverse Events (CTCAE). National Cancer Institute. 12-12-0003. 9-9-0005. Ref Type: Electronic Citation |
| 15145151 | Background | Chism DB, Hanlon AL, Horwitz EM, Feigenberg SJ, Pollack A. A comparison of the single and double factor high-risk models for risk assignment of prostate cancer treated with 3D conformal radiotherapy. Int J Radiat Oncol Biol Phys. 2004 Jun 1;59(2):380-5. doi: 10.1016/j.ijrobp.2003.10.059. |
| 16029788 | Background | Martinez AA, Demanes DJ, Galalae R, Vargas C, Bertermann H, Rodriguez R, Gustafson G, Altieri G, Gonzalez J. Lack of benefit from a short course of androgen deprivation for unfavorable prostate cancer patients treated with an accelerated hypofractionated regime. Int J Radiat Oncol Biol Phys. 2005 Aug 1;62(5):1322-31. doi: 10.1016/j.ijrobp.2004.12.053. |
| 10837943 | Background | Roach M, Lu J, Pilepich MV, Asbell SO, Mohiuddin M, Terry R, Grignon D. Four prognostic groups predict long-term survival from prostate cancer following radiotherapy alone on Radiation Therapy Oncology Group clinical trials. Int J Radiat Oncol Biol Phys. 2000 Jun 1;47(3):609-15. doi: 10.1016/s0360-3016(00)00578-2. |
| 15890582 | Background | Ghilezan MJ, Jaffray DA, Siewerdsen JH, Van Herk M, Shetty A, Sharpe MB, Zafar Jafri S, Vicini FA, Matter RC, Brabbins DS, Martinez AA. Prostate gland motion assessed with cine-magnetic resonance imaging (cine-MRI). Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):406-17. doi: 10.1016/j.ijrobp.2003.10.017. |
| 10348281 | Background | Padhani AR, Khoo VS, Suckling J, Husband JE, Leach MO, Dearnaley DP. Evaluating the effect of rectal distension and rectal movement on prostate gland position using cine MRI. Int J Radiat Oncol Biol Phys. 1999 Jun 1;44(3):525-33. doi: 10.1016/s0360-3016(99)00040-1. |
| 11849792 | Background | Litzenberg D, Dawson LA, Sandler H, Sanda MG, McShan DL, Ten Haken RK, Lam KL, Brock KK, Balter JM. Daily prostate targeting using implanted radiopaque markers. Int J Radiat Oncol Biol Phys. 2002 Mar 1;52(3):699-703. doi: 10.1016/s0360-3016(01)02654-2. |
| 16545919 | Background | Litzenberg DW, Balter JM, Hadley SW, Sandler HM, Willoughby TR, Kupelian PA, Levine L. Influence of intrafraction motion on margins for prostate radiotherapy. Int J Radiat Oncol Biol Phys. 2006 Jun 1;65(2):548-53. doi: 10.1016/j.ijrobp.2005.12.033. Epub 2006 Mar 20. |
| 16111582 | Background | Vargas C, Yan D, Kestin LL, Krauss D, Lockman DM, Brabbins DS, Martinez AA. Phase II dose escalation study of image-guided adaptive radiotherapy for prostate cancer: use of dose-volume constraints to achieve rectal isotoxicity. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):141-9. doi: 10.1016/j.ijrobp.2004.12.017. |
| 16029785 | Background | Vargas C, Martinez A, Kestin LL, Yan D, Grills I, Brabbins DS, Lockman DM, Liang J, Gustafson GS, Chen PY, Vicini FA, Wong JW. Dose-volume analysis of predictors for chronic rectal toxicity after treatment of prostate cancer with adaptive image-guided radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Aug 1;62(5):1297-308. doi: 10.1016/j.ijrobp.2004.12.052. |
| 15685244 | Background | Dearnaley DP, Hall E, Lawrence D, Huddart RA, Eeles R, Nutting CM, Gadd J, Warrington A, Bidmead M, Horwich A. Phase III pilot study of dose escalation using conformal radiotherapy in prostate cancer: PSA control and side effects. Br J Cancer. 2005 Feb 14;92(3):488-98. doi: 10.1038/sj.bjc.6602301. |
| 12128107 | Background | Pollack A, Zagars GK, Starkschall G, Antolak JA, Lee JJ, Huang E, von Eschenbach AC, Kuban DA, Rosen I. Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1097-105. doi: 10.1016/s0360-3016(02)02829-8. |
| 15718316 | Background | Sathya JR, Davis IR, Julian JA, Guo Q, Daya D, Dayes IS, Lukka HR, Levine M. Randomized trial comparing iridium implant plus external-beam radiation therapy with external-beam radiation therapy alone in node-negative locally advanced cancer of the prostate. J Clin Oncol. 2005 Feb 20;23(6):1192-9. doi: 10.1200/JCO.2005.06.154. |
| 7721636 | Background | Shipley WU, Verhey LJ, Munzenrider JE, Suit HD, Urie MM, McManus PL, Young RH, Shipley JW, Zietman AL, Biggs PJ, et al. Advanced prostate cancer: the results of a randomized comparative trial of high dose irradiation boosting with conformal protons compared with conventional dose irradiation using photons alone. Int J Radiat Oncol Biol Phys. 1995 Apr 30;32(1):3-12. doi: 10.1016/0360-3016(95)00063-5. |
| Background | Vargas, C, Martinez, A, and Boike, T. Long term survival benefit of a prospective dose escalation trial using high dose rate (HDR) brachytherapy boost. Int.J.Radiat.Oncol.Biol.Phys.2005. |
| 16786040 | Background | Vargas C, Martinez A, Galalae R, Demanes J, Harsolia A, Schour L, Nuernberg N, Gonzalez J. High-dose radiation employing external beam radiotherapy and high-dose rate brachytherapy with and without neoadjuvant androgen deprivation for prostate cancer patients with intermediate- and high-risk features. Prostate Cancer Prostatic Dis. 2006;9(3):245-53. doi: 10.1038/sj.pcan.4500882. Epub 2006 Jun 20. |
| 16160131 | Background | Zietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, Shipley WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1233-9. doi: 10.1001/jama.294.10.1233. |
| 11704322 | Background | Kupelian PA, Reddy CA, Klein EA, Willoughby TR. Short-course intensity-modulated radiotherapy (70 GY at 2.5 GY per fraction) for localized prostate cancer: preliminary results on late toxicity and quality of life. Int J Radiat Oncol Biol Phys. 2001 Nov 15;51(4):988-93. doi: 10.1016/s0360-3016(01)01730-8. |
| 12095556 | Background | Kupelian PA, Reddy CA, Carlson TP, Altsman KA, Willoughby TR. Preliminary observations on biochemical relapse-free survival rates after short-course intensity-modulated radiotherapy (70 Gy at 2.5 Gy/fraction) for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2002 Jul 15;53(4):904-12. doi: 10.1016/s0360-3016(02)02836-5. |
| 16169683 | Background | Kupelian PA, Thakkar VV, Khuntia D, Reddy CA, Klein EA, Mahadevan A. Hypofractionated intensity-modulated radiotherapy (70 gy at 2.5 Gy per fraction) for localized prostate cancer: long-term outcomes. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1463-8. doi: 10.1016/j.ijrobp.2005.05.054. Epub 2005 Sep 19. |
| 15145147 | Background | Slater JD, Rossi CJ Jr, Yonemoto LT, Bush DA, Jabola BR, Levy RP, Grove RI, Preston W, Slater JM. Proton therapy for prostate cancer: the initial Loma Linda University experience. Int J Radiat Oncol Biol Phys. 2004 Jun 1;59(2):348-52. doi: 10.1016/j.ijrobp.2003.10.011. |
| 15690650 | Background | Ehrenpreis ED, Jani A, Levitsky J, Ahn J, Hong J. A prospective, randomized, double-blind, placebo-controlled trial of retinol palmitate (vitamin A) for symptomatic chronic radiation proctopathy. Dis Colon Rectum. 2005 Jan;48(1):1-8. doi: 10.1007/s10350-004-0821-7. |
| 11869662 | Background | Denton A, Forbes A, Andreyev J, Maher EJ. Non surgical interventions for late radiation proctitis in patients who have received radical radiotherapy to the pelvis. Cochrane Database Syst Rev. 2002;(1):CD003455. doi: 10.1002/14651858.CD003455. |
| 10962052 | Background | Cavcic J, Turcic J, Martinac P, Jelincic Z, Zupancic B, Panijan-Pezerovic R, Unusic J. Metronidazole in the treatment of chronic radiation proctitis: clinical trial. Croat Med J. 2000 Sep;41(3):314-8. |
| 17395040 | Background | Delanian S, Lefaix JL. Current management for late normal tissue injury: radiation-induced fibrosis and necrosis. Semin Radiat Oncol. 2007 Apr;17(2):99-107. doi: 10.1016/j.semradonc.2006.11.006. |
| 10098440 | Background | Lefaix JL, Delanian S, Vozenin MC, Leplat JJ, Tricaud Y, Martin M. Striking regression of subcutaneous fibrosis induced by high doses of gamma rays using a combination of pentoxifylline and alpha-tocopherol: an experimental study. Int J Radiat Oncol Biol Phys. 1999 Mar 1;43(4):839-47. doi: 10.1016/s0360-3016(98)00419-2. |
| 12829674 | Background | Delanian S, Porcher R, Balla-Mekias S, Lefaix JL. Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis. J Clin Oncol. 2003 Jul 1;21(13):2545-50. doi: 10.1200/JCO.2003.06.064. |
| 18374505 | Background | Spry N, Halkett G, Aoun S, Spry J, Yeoh E. Development of a European organization for research and treatment of cancer module to assess the quality of life of patients with proctitis after pelvic radiotherapy for malignancy. Int J Radiat Oncol Biol Phys. 2008 Oct 1;72(2):522-8. doi: 10.1016/j.ijrobp.2007.12.062. Epub 2008 Apr 18. |
| 21219625 | Background | Freeman DE, King CR. Stereotactic body radiotherapy for low-risk prostate cancer: five-year outcomes. Radiat Oncol. 2011 Jan 10;6:3. doi: 10.1186/1748-717X-6-3. |
| 17904306 | Background | Vargas C, Fryer A, Mahajan C, Indelicato D, Horne D, Chellini A, McKenzie C, Lawlor P, Henderson R, Li Z, Lin L, Olivier K, Keole S. Dose-volume comparison of proton therapy and intensity-modulated radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Mar 1;70(3):744-51. doi: 10.1016/j.ijrobp.2007.07.2335. Epub 2007 Sep 27. |
| 19577865 | Background | Michalski JM, Bae K, Roach M, Markoe AM, Sandler HM, Ryu J, Parliament MB, Straube W, Valicenti RK, Cox JD. Long-term toxicity following 3D conformal radiation therapy for prostate cancer from the RTOG 9406 phase I/II dose escalation study. Int J Radiat Oncol Biol Phys. 2010 Jan 1;76(1):14-22. doi: 10.1016/j.ijrobp.2009.01.062. |
| Background | McGowan, D, Hunt, D, Jones, C, et al. Effect of short-term endocrine therapy prior to and during radiation therapy on overall survival in patients with T1b-T2b adenocarcinoma of the prostate and PSA equal to or less than 20: Initial results of RTOG 94-08 (abstract). American Society of Clinical Oncology (ASCO) 2010 Genitourinary Cancers Symposium. (Abstract available online: http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_meeting_categories_view&confID=73, accessed on March 19, 2010). |
| 10837944 | Background | Roach M 3RD, Lu J, Pilepich MV, Asbell SO, Mohiuddin M, Terry R, Grignon D, Lawton C, Shipley W, Cox J. Predicting long-term survival, and the need for hormonal therapy: a meta-analysis of RTOG prostate cancer trials. Int J Radiat Oncol Biol Phys. 2000 Jun 1;47(3):617-27. doi: 10.1016/s0360-3016(00)00577-0. |
| 20047800 | Background | Arcangeli G, Saracino B, Gomellini S, Petrongari MG, Arcangeli S, Sentinelli S, Marzi S, Landoni V, Fowler J, Strigari L. A prospective phase III randomized trial of hypofractionation versus conventional fractionation in patients with high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2010 Sep 1;78(1):11-8. doi: 10.1016/j.ijrobp.2009.07.1691. Epub 2010 Jan 4. |
| 17544601 | Background | Kupelian PA, Willoughby TR, Reddy CA, Klein EA, Mahadevan A. 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 Aug 1;68(5):1424-30. doi: 10.1016/j.ijrobp.2007.01.067. Epub 2007 Jun 4. |
| 21093164 | Background | Mendenhall NP, Li Z, Hoppe BS, Marcus RB Jr, Mendenhall WM, Nichols RC, Morris CG, Williams CR, Costa J, Henderson R. Early outcomes from three prospective trials of image-guided proton therapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):213-21. doi: 10.1016/j.ijrobp.2010.09.024. Epub 2010 Nov 17. |
| 19131179 | Background | Coote JH, Wylie JP, Cowan RA, Logue JP, Swindell R, Livsey JE. Hypofractionated intensity-modulated radiotherapy for carcinoma of the prostate: analysis of toxicity. Int J Radiat Oncol Biol Phys. 2009 Jul 15;74(4):1121-7. doi: 10.1016/j.ijrobp.2008.09.032. Epub 2009 Jan 7. |
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| 19754215 | Background | Friedland JL, Freeman DE, Masterson-McGary ME, Spellberg DM. Stereotactic body radiotherapy: an emerging treatment approach for localized prostate cancer. Technol Cancer Res Treat. 2009 Oct;8(5):387-92. doi: 10.1177/153303460900800509. |
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| 17482880 | Background | Dearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK; RT01 collaborators. Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2007 Jun;8(6):475-87. doi: 10.1016/S1470-2045(07)70143-2. |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |