Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
10 participants
INTERVENTIONAL
2018-04-16
2033-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Prospective Treatment Group
Proton Boost
Proton Boost
13-15 treatments with proton therapy given as a boost to standard of care photon therapy
Retrospective Comparison Group
Retrospective patients previously treated with standard of care photon therapy. There is no patient interaction with this group. Data collection from medical records only.
No interventions assigned to this group
Interventions
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Proton Boost
13-15 treatments with proton therapy given as a boost to standard of care photon therapy
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of low risk prostate cancer (T1c-T2a, Gleason 6, Prostate Specific Antigen (PSA) \<10) -OR-
* Diagnosis of intermediate risk prostate cancer (T1c-T2c, Gleason 7 and/or PSA 10- 20)
* Life expectancy \>10 yrs
* Physically and mentally capable of signing the consent form of their own volition
Exclusion Criteria
* Diagnosis of high risk prostate cancer (T3 or higher, Gleason \>7 and/or PSA \>20)
* Current or historical use of androgen deprivation therapy
* Nodal positivity
* Previous cancer excluding non-melanoma skin cancer
* History of prostatectomy
* History of brachytherapy for prostate cancer
* Life expectancy \<10 yrs
* Physically or mentally incapable of signing the consent form of their own volition
18 Years
MALE
No
Sponsors
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University of Cincinnati
OTHER
Responsible Party
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William Barrett
Director, University of Cincinnati Cancer Institute Medical Director, Charles M. Barrett Cancer Center Professor and Chairman, Radiation Oncology University of Cincinnati
Principal Investigators
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William Barrett, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Cincinnati
Cincinnati, Ohio, United States
Countries
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References
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Boccon-Gibod LM, Dumonceau O, Toublanc M, Ravery V, Boccon-Gibod LA. Micro-focal prostate cancer: a comparison of biopsy and radical prostatectomy specimen features. Eur Urol. 2005 Dec;48(6):895-9. doi: 10.1016/j.eururo.2005.04.033.
Gregori A, Vieweg J, Dahm P, Paulson DF. Comparison of ultrasound-guided biopsies and prostatectomy specimens: predictive accuracy of Gleason score and tumor site. Urol Int. 2001;66(2):66-71. doi: 10.1159/000056573.
Scales CD, Amling CL, Kane CJ, et al. Can unilateral Prostate Cancer be Reliably Predicted Based Upon Biopsy Features? J Urol. 2006; 175:373.
Schulte RT, Wood DP, Daignault S, Shah RB, Wei JT. Utility of extended pattern prostate biopsies for tumor localization: pathologic correlations after radical prostatectomy. Cancer. 2008 Oct 1;113(7):1559-65. doi: 10.1002/cncr.23781.
Arrayeh E, Westphalen AC, Kurhanewicz J, Roach M 3rd, Jung AJ, Carroll PR, Coakley FV. Does local recurrence of prostate cancer after radiation therapy occur at the site of primary tumor? Results of a longitudinal MRI and MRSI study. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):e787-93. doi: 10.1016/j.ijrobp.2011.11.030. Epub 2012 Feb 11.
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.
Peeters ST, Heemsbergen WD, Koper PC, van Putten WL, Slot A, Dielwart MF, Bonfrer JM, Incrocci L, Lebesque JV. 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 May 1;24(13):1990-6. doi: 10.1200/JCO.2005.05.2530.
Andrzejewski P, Kuess P, Knausl B, Pinker K, Georg P, Knoth J, Berger D, Kirisits C, Goldner G, Helbich T, Potter R, Georg D. Feasibility of dominant intraprostatic lesion boosting using advanced photon-, proton- or brachytherapy. Radiother Oncol. 2015 Dec;117(3):509-14. doi: 10.1016/j.radonc.2015.07.028. Epub 2015 Sep 6.
Bossart EL, Stoyanova R, Sandler K, Studenski M, Orman A, Abramowitz M, Pollack A. Feasibility and Initial Dosimetric Findings for a Randomized Trial Using Dose-Painted Multiparametric Magnetic Resonance Imaging-Defined Targets in Prostate Cancer. Int J Radiat Oncol Biol Phys. 2016 Jun 1;95(2):827-34. doi: 10.1016/j.ijrobp.2016.01.052. Epub 2016 Feb 4.
Johansson S, Astrom L, Sandin F, Isacsson U, Montelius A, Turesson I. Hypofractionated proton boost combined with external beam radiotherapy for treatment of localized prostate cancer. Prostate Cancer. 2012;2012:654861. doi: 10.1155/2012/654861. Epub 2012 Jul 8.
Nihei K, Ogino T, Ishikura S, Kawashima M, Nishimura H, Arahira S, Onozawa M. Phase II feasibility study of high-dose radiotherapy for prostate cancer using proton boost therapy: first clinical trial of proton beam therapy for prostate cancer in Japan. Jpn J Clin Oncol. 2005 Dec;35(12):745-52. doi: 10.1093/jjco/hyi193. Epub 2005 Nov 28.
Other Identifiers
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2017-1091
Identifier Type: -
Identifier Source: org_study_id
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