Radiation Therapy Plus Amifostine in Treating Patients With Primary Prostate Cancer
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Purpose
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 study the effectiveness of radiation therapy plus amifostine in treating patients with primary prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer Radiation Toxicity |
Drug: amifostine trihydrate Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Open Label Trial of Amifostine Plus Fractionated Radiotherapy for Primary Prostate Adenocarcinoma (T1a-T3b, NoMo, PSA>10 ng/ml) to Estimate Acute Grade 2 Genitourinary and Gastrointestinal Toxicity |
| Estimated Enrollment: | 25 |
| Study Start Date: | March 1998 |
| Study Completion Date: | June 2001 |
| Primary Completion Date: | June 2001 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Determine the incidence, grade, and time course of acute grade 2 or higher gastrointestinal and genitourinary toxicities in patients with primary prostate adenocarcinoma receiving amifostine plus fractionated radiotherapy. II. Determine the incidence and nature of toxicity associated with amifostine in these patients. III. Assess tumor response to this treatment in these patients. IV. Assess impotency rates following radiotherapy in these patients.
OUTLINE: This is an open label study. Patients receive fractionated radiotherapy five days per week for 7 weeks plus amifostine IV push over 5 minutes, 15 minutes before each radiation treatment. Patients are followed at 1 month after radiotherapy, and then every 3 months for at least 5 years.
PROJECTED ACCRUAL: There will be 25 patients accrued into this study over 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed prostate adenocarcinoma Stage T1a-T3b N0 M0 disease PSA at least 10 ng/mL prior to treatment Must have a risk of seminal vesicle involvement between 10-25% No palpable or radiographic evidence of seminal vesicle involvement
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 24 months Hematopoietic: Not specified Hepatic: SGOT and SGOT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No severe cerebrovascular disease or sustained hypotension not secondary to antihypotensive medication Other: No history of inflammatory bowel disease No history of malignancy other than nonmelanoma skin cancer No underlying medical or psychiatric illness that may impair ability to participate in study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the prostate area Surgery: No prior radical prostatectomy Other: No hypertensive medications if blood pressure less than 120/70
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | James Oleson, M.D., Arizona Cancer Center at University of Arizona Health Science Center |
| ClinicalTrials.gov Identifier: | NCT00003307 History of Changes |
| Other Study ID Numbers: | CDR0000066254, P30CA023074, UARIZ-HSC-9817, ALZA-98-005-ii, NCI-V98-1412 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 12, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Arizona:
|
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer stage III prostate cancer radiation toxicity |
Additional relevant MeSH terms:
|
Adenocarcinoma Prostatic Neoplasms Radiation Injuries Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Genital Diseases, Male Prostatic Diseases Wounds and Injuries Amifostine Radiation-Protective Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013