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Radiation Therapy in Treating Patients With Prostate Cancer



Radiation Therapy in Treating Patients With Prostate Cancer

For Condition: stage 2 prostate cancer,stage 3 prostate cancer,adenocarcinoma of the prostate
Status: No longer recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy may be an effective treatment for prostate cancer. PURPOSE: Phase I trial to study the effectiveness of radiation therapy in treating patients who have stage II or stage III prostate cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of radiotherapy using 3-dimensional (3D) conformal techniques in patients with stage II or III adenocarcinoma of the prostate. II. Determine the morbidity of high-dose 3D conformal therapy in these patients. PROTOCOL OUTLINE: This is a dose escalation study. Patients undergo 3-dimensional conformal radiotherapy 4-5 days a week for at least 8 weeks. Cohorts of 20-40 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 10% of patients experience dose-limiting toxicity. Patients are followed at 3 months, every 6 months for 5 years, and then annually thereafter. PROJECTED ACCRUAL: A minimum of 40 patients will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Locally advanced (T2c-T3) adenocarcinoma of the prostate including: Bulky tumors confined to prostate (stage II); Tumors extending beyond capsule (stage III) - PSA no greater than 20 ng/mL - No regional lymph node involvement (by CT scan or surgical sampling) - No distant metastases --Prior/Concurrent Therapy-- - Biologic therapy: No prior biologic therapy - Chemotherapy: No prior chemotherapy - Endocrine therapy: Prior hormonal therapy allowed - Radiotherapy: No prior radiotherapy (including pelvic irradiation) - Surgery: No prior radical surgery for carcinoma of the prostate --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: WBC greater than 4,000/mm3; Platelet count greater than 100,000/mm3; Hemoglobin greater than 11 g/dL - Hepatic: Not specified - Renal: Not specified - Other: No major medical or psychiatric illness that would preclude study; No metallic pelvic prosthesis
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MichaelZelefsky,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center
New York City,  New York,  10021
United States
 


Additional Information:
Study ID Numbers:  CDR0000077099;  MSKCC-91022,NCI-V91-0102
Study Start Date: February 1991
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002480

Other Adenocarcinoma Of The Prostate Studies:
1. Rapid Hormone Cycling With Testosterone and Leuprolide Combined With Docetaxel in Treating Patients With Recurrent or Metastatic Adenocarcinoma (Cancer) of the Prostate

2. Hyperthermia Plus Radiation Therapy in Treating Patients With Nonmetastatic Advanced Prostate Cancer

3. Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer

4. Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy

5. ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

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