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Computer Planned Radiation Therapy in Treating Patients With Prostate Cancer



Computer Planned Radiation Therapy in Treating Patients With Prostate Cancer

For Condition: stage 2 prostate cancer,adenocarcinoma of the prostate
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy. PURPOSE: Phase II trial to study the effectiveness of radiation therapy that has been planned with a computer in treating patients who have prostate cancer.
Details: OBJECTIVES: - Establish the efficacy of high-dose three-dimensional conformal radiotherapy in patients with intermediate prognostic risk adenocarcinoma of the prostate. - Determine the PSA relapse-free survival rate of this patient population. OUTLINE: Patients receive high-dose three-dimensional conformal radiotherapy 4-5 days per week for at least 9 weeks. Patients are evaluated at least weekly during radiotherapy and at 2 and 4 months after treatment completion. Thereafter, patients are followed every 6 months for a total of 3 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 1 year.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven intermediate prognostic risk (T1-T2) adenocarcinoma of the prostate - Previously untreated (except for hormonal therapy) - PSA levels greater than 10 ng/mL and Gleason scores no greater than 6 OR - PSA levels no greater than 10 ng/mL and Gleason scores at least 7 - Patients requiring volume reduction of prostate prior to radiotherapy continue to be treated at least 3 months on neoadjuvant hormonal therapy prior to radiation - No evidence of distant metastases - No regional lymph node involvement PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Karnofsky 70-100% Life expectancy: - Not specified Hematopoietic: - Hemoglobin greater than 11 g/dL - WBC greater than 4,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Not specified Renal: - Not specified Other: - No major medical illness - No psychosis - No metallic pelvic prosthesis PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - See Disease Characteristics - Prior neoadjuvant antiandrogen therapy allowed Radiotherapy: - No prior radiotherapy - No prior pelvic irradiation Surgery: - No prior radical surgery for carcinoma of the prostate
Total Enrollment: 

Location and Contact Information:

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

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Michael  Zelefsky 212-639-6802


Additional Information:
Study ID Numbers:  CDR0000065838;  MSKCC-97064,NCI-H97-0006
Study Start Date: 
Record last reviewed: August 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003104

Other Stage 2 Prostate Cancer Studies:
1. Brachytherapy in Treating Patients With Recurrent Prostate Cancer

2. Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer

3. APC8015 and Bevacizumab in Treating Patients With Prostate Cancer

4. Docetaxel in Treating Patients Who Have Undergone Surgery for Prostate Cancer

5. Combination Chemotherapy Followed by Surgery in Treating Patients With Localized Prostate Cancer

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