Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer

Prostate Cancer Clinical Trial

— PR07  

Official title:

An Expanded Phase II Study of Hypofractionated Dose Intense Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01368055
• Other study ID #: UFPTI 1103-PR07
• Secondary ID: IRB201701768
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2011
• Est. completion date: September 2036

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 361
• Est. completion date: September 2036
• Est. primary completion date: September 2036
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prostate cancer.

• Gleason score 2-6 or 7.

• PSA = 20 ng/ml.

Exclusion Criteria:

• Previous prostate cancer surgery or pelvic radiation.

• Prior/concurrent systemic chemotherapy for prostate cancer.

• Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.

• History of hip replacement.

• Prior intrapelvic surgery.

• Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its uses during radiation.

• Receiving continuous and current anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), dabigatran etexilate mesylate (Pradaxa),enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• 70 Gy/CGE
Low Risk
• 72.5 Gy/CGE
Intermediate Risk

Locations

Country	Name	City	State
United States	University of Florida Proton Therapy Institute	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (50)

American Cancer Society. 2010. Ref Type: Electronic Citation

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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. — View Citation

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Kuban DA, Tucker SL, Dong L, Starkschall G, Huang EH, Cheung MR, Lee AK, Pollack A. Long-term results of the M. D. Anderson randomized dose-escalation trial for prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):67-74. doi: 10.1016/j.ijrobp.2007.06.054. Epub 2007 Aug 31. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

Martin JM, Rosewall T, Bayley A, Bristow R, Chung P, Crook J, Gospodarowicz M, McLean M, Menard C, Milosevic M, Warde P, Catton C. Phase II trial of hypofractionated image-guided intensity-modulated radiotherapy for localized prostate adenocarcinoma. Int J Radiat Oncol Biol Phys. 2007 Nov 15;69(4):1084-9. doi: 10.1016/j.ijrobp.2007.04.049. Epub 2007 Jul 2. — View Citation

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. — View Citation

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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. — View Citation

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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. Erratum In: JAMA. 2008 Feb 27;299(8):899-900. — View Citation

* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of treatment-related grade 2 or higher rectal bleeding.		2 years after completion of radiation therapy
Secondary	Analyzation of quality of life		After radiation: every 6 months for 3 years, then annually for 20 years
Secondary	Analysis of treatment-related morbidity		Cumulative incidence up to 20 years after completion of radiation therapy
Secondary	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
Secondary	Analysis of overall survival	Proportion of patients alive after completion of treatment	Cumulative incidence up to 20 years after completion of radiation therapy

External Links

•   (Contact the University of Florida Proton Therapy Institute)