Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Amifostine in Protecting the Rectum in Patients Undergoing Radiation Therapy for Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care, Treatment	Closed	18 and over	NCI	NCI-02-C-0215 NCT00045253

Objectives

1. Determine acute rectal toxicity in patients with prostate cancer receiving topical amifostine and radiotherapy.
2. Determine late rectal toxicity in patients treated with this regimen.
3. Determine the relationship between this regimen and toxicity, quality of life, rectal dose-volume histograms, and proctoscopic examinations in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed adenocarcinoma of the prostate
• No distant metastatic disease
  • Negative bone scan necessary if prostate-specific antigen (PSA) is greater than 10 ng/mL or Gleason score is greater than 7

Prior/Concurrent Therapy:

Biologic therapy

• Concurrent PSA vaccine allowed provided patient is also enrolled on protocol NCI-00-C-0154

Chemotherapy

• No concurrent cytotoxic chemotherapy

Endocrine therapy

• Concurrent anti-androgen therapy allowed for intermediate- or high-risk patients

Radiotherapy

• No prior pelvic or prostatic radiotherapy

Surgery

• Not specified

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• No other active malignancy except nonmelanoma skin cancer
• No chronic inflammatory bowel disease
• No cognitive impairment that would preclude informed consent
• No other medical condition that would preclude study participation
• HIV negative

Expected Enrollment

A total of 18-33 patients will be accrued for this study within 1 year.

Outline

Patients are stratified according to prior prostatectomy (yes vs no) and risk (low vs intermediate vs high).

Patients receive amifostine intrarectally over 30-90 seconds 30-45 minutes prior to radiotherapy 5 days a week for 7-8 weeks. Patients are advised to retain the amifostine for as long as possible (at least 20 minutes) until the radiation treatment has been delivered. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at weeks 5 and 7 during therapy, at 1 month, every 3 months for 6 months, every 6 months for 1.5 years, and then annually for 3 years.

Patients are followed at 1 month, every 3 months for 6 months, every 6 months for 1.5 years, and then annually for 3 years.

Simone NL, Ménard C, Soule BP, et al.: Intrarectal amifostine during external beam radiation therapy for prostate cancer produces significant improvements in Quality of Life measured by EPIC score. Int J Radiat Oncol Biol Phys 70 (1): 90-5, 2008.[PUBMED Abstract]

Muanza TM, Albert PS, Smith S, et al.: Comparing measures of acute bowel toxicity in patients with prostate cancer treated with external beam radiation therapy. Int J Radiat Oncol Biol Phys 62 (5): 1316-21, 2005.[PUBMED Abstract]

Ménard C, Camphausen K, Muanza T, et al.: Clinical trial of endorectal amifostine for radioprotection in patients with prostate cancer: rationale and early results. Semin Oncol 30 (6 Suppl 18): 63-7, 2003.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Kevin Camphausen, MD, Principal investigator		Ph: 301-496-5457 Email: camphauk@mail.nih.gov

Registry Information
Official Title		Amifostine As A Rectal Protector During External Beam Radiotherapy For Prostate Cancer: A Phase II Study
Trial Start Date		2002-06-03
Registered in ClinicalTrials.gov		NCT00045253
Date Submitted to PDQ		2002-07-01
Information Last Verified		2007-02-21

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