Gender
Male
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Use of 5-alpha reductase inhibitors (finasteride, dutasteride) specifically
prescribed for the treatment of prostate cancer
- 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
- Active lupus or scleroderma
- 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
- Hepatic insufficiency with AST, ALT, or Bilirubin > 2 x upper limit of
normal,clinical jaundice, and/or coagulation defects
- 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