Proton Boost in Prostate Cancer

Cancer of the Prostate Clinical Trial

Official title:

Assessing the Effectiveness of Photon Therapy With a Proton Therapy Boost in the Treatment of Prostate Cancer as Compared to Photon Therapy Alone

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03564275
• Other study ID #: 2017-1091
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: April 2033

Study information

• Verified date: November 2023
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: April 2033
• Est. primary completion date: April 2033
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =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

Exclusion Criteria:

• < 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

Related Conditions & MeSH terms

• Cancer of the Prostate
• Prostatic Neoplasms

Intervention

Radiation:
• Proton Boost
13-15 treatments with proton therapy given as a boost to standard of care photon therapy

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Progression Free Survival	Measured by time to cancer recurrence	Monitored for 10 years after completion of radiation therapy
Secondary	Overall Survival	Measured by time to cancer-related death	Monitored for 10 years after completion of radiation therapy