Phase 2 N=30 Supportive Care

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

Prostatic Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT00040365 ↗

Enrolled (actual)

Serious AEs

3.3%

Results posted

Mar 2012

Primary outcome: Primary: 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. — 20.69 Percentage of Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Amifostine trihydrate (Drug); Radiation therapy (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: National Cancer Institute (NCI)
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.	20.69	—
SECONDARY Percentage of Participants With a Good Toxicity Outcome Who Experienced Late Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer.	83.33	—
SECONDARY Number of Participants With Adverse Events	30	—
SECONDARY Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment Over Time (Late Follow-up 18 Months)	0.6	—
SECONDARY Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)	91.13; 92.86; 71.43; 67.33; 1.06; 69.76	—
SECONDARY Number of Participants Who Had Proctoscopic Examinations	30	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00040365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.