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Protocol Number:
02-C-0215
- Title:
Amifostine as a Rectal Protector During External Beam Radiotherapy for Prostate Cancer: A Phase II Study
- Number:
02-C-0215
- 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 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.
- Sponsoring Institute:
-
National Cancer Institute (NCI)
- Recruitment Detail
- Type:
No longer recruiting/follow-up only
- Gender:
Male
- Referral Letter Required:
No
- Population Exclusion(s):
Female
Children
- Eligibility Criteria:
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Special Instructions:
Currently Not Provided
- Keyword(s):
-
Prostate Cancer
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Radiation Therapy
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Rectal Toxicity
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Amifostine
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Radioprotector
- Recruitment Keyword(s):
-
Prostate Cancer
- Condition(s):
-
Prostatic Neoplasms
- Investigational Drug(s):
- None
- Investigational Device(s):
- None
- Interventions:
-
Drug: Amifostine
- Supporting Site:
-
National Cancer Institute
- Contact(s):
-
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Citation(s):
-
Greenlee RT, Hill-Harmon MB, Murray T, Thun M Cancer statistics, 2001 CA Cancer J Clin 2001 Jan-Feb;51(1):15-36
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Fuks Z, Leibel SA, 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 Bi
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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
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Bethesda, Maryland 20892. Last update: 01/30/2009
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