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Radiation Therapy Plus Amifostine in Treating Patients With Primary Prostate Cancer



Radiation Therapy Plus Amifostine in Treating Patients With Primary Prostate Cancer

For Condition: radiation toxicity,stage 1 prostate cancer,stage 3 prostate cancer,stage 2 prostate cancer,adenocarcinoma of the prostate
Status: No longer recruiting
Sponsor(s): Arizona Cancer Center ,
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type:  Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JamesOleson,  Study Chair,  Arizona Cancer Center

Arizona Cancer Center
Tucson,  Arizona,  85724
United States
 


Additional Information:
Study ID Numbers:  CDR0000066254;  UARIZ-HSC-9817,NCI-V98-1412,ALZA-98-005-ii
Study Start Date: March 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003307

Other Stage 1 Prostate Cancer Studies:
1. Radiation Therapy in Treating Patients With Prostate Cancer

2. Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer

3. Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer

4. Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate

5. Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer

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