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Amifostine as a Rectal Protector During External Beam Radiotherapy for Prostate Cancer: A Phase II Study

Phase 2
18 Years
Not Enrolling
Prostatic Neoplasms

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Trial Information

Amifostine as a Rectal Protector During External Beam Radiotherapy for Prostate Cancer: A Phase II Study

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.

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).


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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Percentage of Participants With a Good Toxicity Outcome Who Experienced an Acute Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer.

Outcome Description:

A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. The Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity scoring scheme and the Rectal Mucosal Toxicity response criteria will be used to assess rectal toxicity. The RTOG measures the rectal toxicities. The physician assigns a grade based on symptoms reported by the patient. For details about the RTOG (method and scoring of radiation morbidity, etc.) see

Outcome Time Frame:

RTOG Acute was used on week 5 and 7

Safety Issue:


Principal Investigator

Kevin A camphausen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

June 2002

Completion Date:

June 2011

Related Keywords:

  • Prostatic Neoplasms
  • Prostate Cancer
  • Radiation Therapy
  • Rectal Toxicity
  • Amifostine
  • Radioprotector
  • Neoplasms
  • Prostatic Neoplasms



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