Proton Boost in Prostate Cancer

NCT03564275 | Active Not Recruiting DMC

• 1 other identifier: 2017-1091
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study uses photon radiation with a proton boost to treat prostate cancer. The purpose of this study is to determine if proton therapy as a boost following photon intensity modulated radiation therapy (IMRT) produces decreased toxicity as compared to conventional photon IMRT alone in the treatment of prostate cancer. Our secondary objective is to determine the effectiveness of this treatment regimen. Effectiveness will be determined by length of time to progression or recurrence of disease and overall survival. Patients on this study will be treated with a course of photon radiation therapy followed by a boost course of proton radiation.

Conditions

Cancer of the Prostate

Keywords

Radiation Therapy; Proton Therapy

Outcome Measures

Primary Outcomes (6)

• Hematuria - Change from baseline

  Common Terminology Criteria for Adverse Events - Hematuria Scale - 1(least severe) - 5 (most severe)

  Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years

• Urinary Incontinence - Change from baseline

  Common Terminology Criteria for Adverse Events - Urinary Incontinence Scale - 1(least severe) - 3 (most severe)

  Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years

• Dysuria - Change from baseline

  Presence or Absence

  Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years

• International Prostate Symptom Score - Change from baseline

  Records patient reported urinary symptoms - Scale 1-35 - 1-7 Mild symptoms, 8-19 Moderate symptoms, 20-35 Severe symptoms

  Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years

• Rectal Bleeding - Change from baseline

  Common Terminology Criteria for Adverse Events - Rectal Hemorrhage Scale - 1(least severe) - 5 (most severe)

  Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years

• Erectile Dysfunction - Change from baseline

  Common Terminology Criteria for Adverse Events - Erectile Dysfunction Scale - 1(least severe) - 3 (most severe)

  Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years

Secondary Outcomes (2)

• Progression Free Survival

  Monitored for 10 years after completion of radiation therapy

• Overall Survival

  Monitored for 10 years after completion of radiation therapy

Study Arms (2)

Prospective Treatment Group

EXPERIMENTAL

Proton Boost

Radiation: Proton Boost

Retrospective Comparison Group

NO INTERVENTION

Retrospective patients previously treated with standard of care photon therapy. There is no patient interaction with this group. Data collection from medical records only.

Interventions

Proton Boost RADIATION

13-15 treatments with proton therapy given as a boost to standard of care photon therapy

Prospective Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• 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

You may not qualify if:

• \< 18 years of age
• 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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Related Publications (11)

• 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.

  PMID: 16125298 BACKGROUND

• 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.

  PMID: 11223746 BACKGROUND

• Scales CD, Amling CL, Kane CJ, et al. Can unilateral Prostate Cancer be Reliably Predicted Based Upon Biopsy Features? J Urol. 2006; 175:373.

  BACKGROUND

• 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.

  PMID: 18726951 BACKGROUND

• 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.

  PMID: 22331003 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.

  PMID: 12128107 BACKGROUND

• 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.

  PMID: 16648499 BACKGROUND

• 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.

  PMID: 26349588 BACKGROUND

• 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.

  PMID: 27020109 BACKGROUND

• 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.

  PMID: 22848840 BACKGROUND

• 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.

  PMID: 16314345 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• William Barrett, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, University of Cincinnati Cancer Institute Medical Director, Charles M. Barrett Cancer Center Professor and Chairman, Radiation Oncology University of Cincinnati

Model Details: Matched pair analysis. Each prospective patient will be matched with two historical patients based on the inclusion, exclusion and match criteria.

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 20, 2018
• Study Start: April 16, 2018
• Primary Completion (Estimated): April 1, 2033
• Study Completion (Estimated): April 1, 2033
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

US (1)