Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer

Korábbi kezelés

• Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer
• Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy
• Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy for a different cancer is permitted
• Prior radiation, including brachytherapy, to the region of the prostate that would result in overlap of RT fields

Más betegség

• Use of 5-alpha reductase inhibitors (finasteride, dutasteride) specifically prescribed for the treatment of prostate cancer
• Severe, active co-morbidity, including but not limited to,unstable angina within the last 6 months without subsequent corrective cardiovascular procedure,or acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Acquired Immune Deficiency Syndrome (AIDS); note, however, that HIV testing is not required for entry into this protocol.Patients who are HIV seropositive but do not meet criteria for diagnosis of AIDS are eligible for study participation

Laborértékek

• Hepatic insufficiency with AST, ALT, or Bilirubin > 2 x upper limit of normal,clinical jaundice, and/or coagulation defects

Egyéb

• Active lupus or scleroderma

• Age > or = 70 years and/or Charlson comorbidity index score > or = 2
• Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma
• Two or more of the following intermediate risk features for recurrence, Gleason Score = 7, PSA 10-20 ng/ml, Clinical Stage T2b-T2c Percent positive biopsy cores > or = 50%
• One or more of the following high risk features for recurrence, Gleason Score 8-10, PSA > 20 ng/ml, Clinical Stage T3a-T4
• Clinically negative lymph nodes as established by imaging, nodal sampling, or dissection
• No evidence of bone metastases on bone scan
• History/physical examination via the Charlson Comorbidity Index within 60 days prior to registration
• Zubrod Performance Status 0-2
• Age > or = 18
• Baseline serum PSA within 60 days prior to registration
• Baseline serum testosterone obtained within 60 days prior to registration
• Study entry PSA and serum testosterone must not be obtained during the following time frames, 10-day period following prostate biopsy, following initiation of oral androgen manipulation, within 30 days after discontinuation of finasteride or dutasteride
• CBC/ differential obtained within 60 days prior to registration with adequate bone marrow function
• Patient must be able to provide study-specific informed consent prior to study entry
• Liver function parameters as follows, Total Bilirubin < or = 2 x institutional upper limit of normal, AST (SGOT) or ALT (SGPT) < or = 2 x institutional upper limit normal