Amifostine to Protect the Rectum During External Beam Radiotherapy for Prostate Cancer

2014-08-27 03:55:59 | BioPortfolio


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.


Normal tissue tolerance of the rectum limits the dose of radiation that can be delivered to the prostate for curative treatment of prostate cancer. Amifostine is a radioprotector, an agent that reduces tissue damage incurred by ionizing radiation. It has been well studied in humans and is approved for intravenous use. Rectal administration results in a preferential accumulation of Amifostine in the rectal mucosa, and neither free parent compound nor free active metabolite have been detected in systemic circulation. This trial proposes to observe the rate of early and late bowel toxicity in a group of patients with prostate cancer receiving standard high dose, 3D conformal external beam radiotherapy and concurrent intra-rectal applications of Amifostine. Primary measures of rectal toxicity (RTOG radiation morbidity scoring) will also be compared with self-assessment measures of quality of life, and rectal radiation dose as assessed by dose-volume histograms.

Study Design

Masking: Open Label, Primary Purpose: Supportive Care


Prostatic Neoplasms


Amifostine trihydrate, radiation therapy


National Institutes of Health Clinical Center, 9000 Rockville Pike
United States


Active, not recruiting


National Institutes of Health Clinical Center (CC)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:55:59-0400

Clinical Trials [2540 Associated Clinical Trials listed on BioPortfolio]

Radiation Therapy Plus Amifostine in Treating Patients With Primary Prostate Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Amifostine may protect normal cells from the side effects of radiation therapy. PURPOSE: Phase II trial to stud...

Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of radiation therapy. Drugs used in chem...

Amifostine Plus Chemotherapy and Radiation Therapy in Treating Patients With Advanced, Unresectable Head and Neck Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs, such as ...

Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix

RATIONALE: Drugs used in chemotherapy, such as cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to dam...

Amifostine in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer

RATIONALE: Amifostine may be an effective treatment for the toxic side effects caused by radiation therapy and chemotherapy. It is not yet known whether chemotherapy and radiation therapy ...

PubMed Articles [11227 Associated PubMed Articles listed on BioPortfolio]

Evolving concepts in prostatic neuroendocrine manifestations: from focal divergent differentiation to AMPHICRINE carcinoma.

Prostatic neuroendocrine manifestations encompass a heterogeneous spectrum of morphological entities. In the era of evidence-based and precision-led treatment, distinction of biologically relevant cli...

50 Gy Stereotactic Body Radiation Therapy to the Dominant Intra-Prostatic Nodule: Results from a Phase Ia/b Trial.

Although localized prostate cancer (PCa) is multifocal, the dominant intraprostatic nodule (DIN) is responsible for disease progression after radiation therapy. PCa expresses antigens that could be re...

The opportunities of computer simulation training in radiation therapy.

The use of computer simulation is arguably more widespread in other industries than in medicine. However, it has filtered into mainstream use in radiation therapy via a commercial product born from co...

Radio-protective dosimetry of Pangasius sutchi as a biomarker, against gamma radiation dosages perceived by genotoxic assays.

Exposure to ionizing radiation is harmful to any living organism. It may cause varying levels of genetic mutation or ultimately death. Synthetic compounds have been used to counteract the hazardous ef...

A roadmap for important centers of growth in the pediatric skeleton to consider during radiation therapy and associated clinical correlates of radiation-induced growth toxicity.

With the increasing use of advanced radiation techniques such as intensity modulated radiation therapy, stereotactic radiation therapy, and proton therapy, radiation oncologists now have the tools to ...

Medical and Biotech [MESH] Definitions

A nitrogen mustard linked to estradiol, usually as phosphate; used to treat prostatic neoplasms; also has radiation protective properties.

Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).

A phosphorothioate proposed as a radiation-protective agent. It causes splenic vasodilation and may block autonomic ganglia.

Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.

Organs which might be damaged during exposure to a toxin or to some form of therapy. It most frequently refers to healthy organs located in the radiation field during radiation therapy.

More From BioPortfolio on "Amifostine to Protect the Rectum During External Beam Radiotherapy for Prostate Cancer"

Quick Search


Relevant Topic

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Searches Linking to this Trial