Amifostine to Protect the Rectum During External Beam Radiotherapy for Prostate Cancer
Prostatic Neoplasms
About this trial
This is an interventional supportive care trial for Prostatic Neoplasms focused on measuring Prostate Cancer, Radiation Therapy, Rectal Toxicity, Amifostine, Radioprotector
Eligibility Criteria
INCLUSION CRITERIA: Pathologically confirmed adenocarcinoma of the prostate gland. Age greater than or equal to 18 years. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed (this does not include routine laboratory tests or imaging studies required to establish eligibility). EXCLUSION CRITERIA: Other active malignancy (except for non-melanoma skin cancer). Patient with a prior history of pelvic or prostate radiotherapy. Patients with chronic inflammatory bowel disease. Patients with distant metastatic disease. Cognitively impaired patients who cannot give informed consent. Human Immunodeficiency Virus (HIV) positivity. Other medical conditions deemed by the principal investigator (PI) or associates to make the patient ineligible for high dose radiotherapy.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Experimental
Amifostine
1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).