Amifostine to Protect the Rectum During External Beam Radiotherapy for Prostate Cancer
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Intervention: Amifostine trihydrate; Radiation therapy
Intervention description: 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.
Intervention MeSH terms: Amifostine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Radiation Therapy; Rectal Toxicity; Amifostine; Radioprotector

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.
    

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.