Amifostine to Protect the Rectum During External Beam Radiotherapy for Prostate Cancer

Summary

This study will evaluate the safety and effectiveness of a drug called amifostine in reducing the bowel side effects of radiation treatment for prostate cancer. Amifostine is a 'radioprotector' medicine that to protects normal tissue from radiation damage. This study will determine whether placing amifostine in the rectum during radiation treatment for prostate cancer can decrease common side effects of treatment, including diarrhea, painful bowel movements, bleeding, and gas. Patients 18 years of age or older with prostate cancer may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, bone scan if a recent one is not available, and possibly computed tomography (CT) and magnetic resonance imaging (MRI) scans of the pelvis. They will also have a liquid retention test, in which they are given an enema of 4 tablespoons of salt water that they must retain for 20 minutes. Participants will receive standard radiation therapy for prostate cancer-5 consecutive days for 8 weeks-in the National Institutes of Health (NIH) Radiation Oncology Clinic. Amifostine will be placed in the rectum by a mini-enema before each radiation treatment so that it covers the lining of the rectum. To determine the side effects of the treatment, patients will undergo a proctoscopic examination before beginning radiation therapy, two times during therapy, and at each follow-up visit for 5 years after treatment ends. This examination involves inserting a proctoscope (a thin flexible tube with a light at the end) into the rectum and taking pictures. Patients will be followed in the clinic at visits scheduled 1, 3, 6, 12, 18, 24, 36, 48, and 60 months after treatment for a physical examination and routine blood tests, proctoscopic examination, and review of bowel symptoms.

Timeline

Start

2002-06

Primary completion

2010-05

Completion

2011-06

Publications

• Background Greenlee RT, Hill-Harmon MB, Murray T, Thun M. Cancer statistics, 2001. CA Cancer J Clin. 2001 Jan-Feb;51(1):15-36. doi: 10.3322/canjclin.51.1.15.
• Background Fuks Z, Leibel SA, Wallner KE, Begg CB, Fair WR, Anderson LL, Hilaris BS, Whitmore WF. The effect of local control on metastatic dissemination in carcinoma of the prostate: long-term results in patients treated with 125I implantation. Int J Radiat Oncol Biol Phys. 1991 Aug;21(3):537-47. doi: 10.1016/0360-3016(91)90668-t.
• Background Pollack A, Smith LG, von Eschenbach AC. External beam radiotherapy dose response characteristics of 1127 men with prostate cancer treated in the PSA era. Int J Radiat Oncol Biol Phys. 2000 Sep 1;48(2):507-12. doi: 10.1016/s0360-3016(00)00620-9.
• Results Simone NL, Menard C, Soule BP, Albert PS, Guion P, Smith S, Godette D, Crouse NS, Sciuto LC, Cooley-Zgela T, Camphausen K, Coleman CN, Singh AK. Intrarectal amifostine during external beam radiation therapy for prostate cancer produces significant improvements in Quality of Life measured by EPIC score. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):90-5. doi: 10.1016/j.ijrobp.2007.05.057. Epub 2007 Sep 12.
• Results Simone, NL; Soule, BP; Ménard, C; Albert, P; Guion, P; Smith, S; Godette, D; Coleman, CN; Singh, AK. Assessing Rectal Toxicity in a Pilot Study using Intrarectal Amifostine and Concurrent Radiation. 42nd annual meeting of the American society of clinical oncology, Atlanta, GA, June 2006.
• Results Menard C, Camphausen K, Muanza T, Sears-Crouse N, Smith S, Ben-Josef E, Coleman CN. Clinical trial of endorectal amifostine for radioprotection in patients with prostate cancer: rationale and early results. Semin Oncol. 2003 Dec;30(6 Suppl 18):63-7. doi: 10.1053/j.seminoncol.2003.11.016.
• Results Singh AK, Menard C, Guion P, Simone NL, Smith S, Crouse NS, Godette DJ, Cooley-Zgela T, Sciuto LC, Coleman J, Pinto P, Albert PS, Camphausen K, Coleman CN. Intrarectal amifostine suspension may protect against acute proctitis during radiation therapy for prostate cancer: a pilot study. Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):1008-13. doi: 10.1016/j.ijrobp.2006.02.030. Epub 2006 May 26.
• Results Simone NL, Ménard C, Singh AK, Guion P, Smith S, Crouse NS, Godette D, Cooley-Zgela T, Sciuto LC, Coleman J, Pinto, P, Albert PS, Camphausen K, Coleman CN. Intrarectal amifostine suspension may protect against acute proctitis during radiation therapy for prostate cancer: oral presentation at 91st scientific assembly and annual meeting of the radiological society of North America, Chicago, IL, 2005.
• Results Muanza TM, Albert PS, Smith S, Godette D, Crouse NS, Cooley-Zgela T, Sciuto L, Camphausen K, Coleman CN, Menard C. Comparing measures of acute bowel toxicity in patients with prostate cancer treated with external beam radiation therapy. Int J Radiat Oncol Biol Phys. 2005 Aug 1;62(5):1316-21. doi: 10.1016/j.ijrobp.2004.12.083.

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