At a glance
ClinicalIndex Comparison Record- ✓Pathologically confirmed adenocarcinoma of the prostate gland
- ✓Age 18 years or older
- ✓ECOG performance status 0 or 1
- ✕Prior history of pelvic or prostate radiotherapy
- ✕Chronic inflammatory bowel disease
- ✕Distant metastatic disease
- ✕Other active malignancy (except non-melanoma skin cancer)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Amifostine as a Rectal Protector During External Beam Radiotherapy for Prostate Cancer: A Phase II Study
In Brief
A Phase 2 clinical trial evaluating Amifostine trihydrate and Radiation therapy for Prostatic Neoplasms. Completed, enrolled 30 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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).
The treatment will be delivered in at least two phases. The first field reduction will occur after 46Gy and the second field reduction will occur after 70Gy.