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

• 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. [ Time Frame: RTOG Acute was used on week 5 and 7 ] [ Designated as safety issue: Yes ]
  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 http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx
  
  

• 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. [ Time Frame: The late rectal toxicity has been assessed at 1, 3, 6, 12, 18, 24, 36, and 60 months after the completion of treatment. ] [ Designated as safety issue: Yes ]
  A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. Week 5, 7 were during treatment measuring acute toxicity. 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 see http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx.
  
  
• Number of Participants With Adverse Events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
  
  
• Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment Over Time (Late Follow-up 18 Months) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  The EPIC bowel assessment is a 26 item short form evaluation that assess patient function and bother after prostate treatment. The Expanded Prostate Cancer Index Composite is a self assessment questionnaire designed to measure quality of life in patients with prostate cancer. The questionnaire is scored on a scale of 0-100 with higher scores correlated with higher function and quality of life. For this study, the Bowel Domain was analyzed alongside the RTOG acute and late gastrointestinal morbidity scores. For details re: EPIC, see http://www.med.umich.edu/urology/research/EPIC/EPIC-2.2002.pdf
  
  
• Measures of Quality of Life (QOL)-(Late Follow-up 18 Months) [ Time Frame: Baseline, week 5, 7 , and months 1, 3, 6, 12, and 18 ] [ Designated as safety issue: No ]
  Radiation toxicity consists of the Radiation Therapy Oncology Group(RTOG)acute(within 90 days of treatment)and RTOG late(>90days after treatment). This scoring system assigns a toxicity grade (0-4) based on symptoms with 0 being the best outcome. The Expanded Prostate Cancer Index Composite(EPIC) questionnaire consists of 50 quality of life items divided into 4 domains, urinary, bowel, sexual and hormonal. Each independent domain renders a scoring of 0-100 with 100 being the best score. The EPIC and RTOG scores were correlated not combined.
  
  
• Number of Participants Who Had Proctoscopic Examinations [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  Proctoscopic scoring of mucosal change was performed according to a descriptive scale, described by Wachter et al, which assigns grades of mucosal congestion, telangiectasia, ulcerations, stricture, and necrosis.
  
  

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.