Amifostine to Protect the Rectum During External Beam Radiotherapy for Prostate Cancer
Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
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.