Expired Study
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New York, New York 10021


Purpose:

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: This phase II trial is studying how well radiation therapy that has been planned with a computer works in treating patients with prostate cancer.


Study summary:

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.


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: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified 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


NCT ID:

NCT00003104


Primary Contact:

Study Chair
Michael J. Zelefsky, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 16, 2017

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