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

Recruitment & Eligibility

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

Study & Design

Arm && Interventions

Group	Intervention	Description
Oral Androgen Therapy	Finasteride	Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride)
Oral Androgen Therapy	Dutasteride	Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride)
Oral Androgen Therapy	Radiation	Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride)
Oral Androgen Therapy	Bicalutamide	Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride)

Primary Outcome Measures

Name	Time	Method
Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire	Baseline, 6 months, and 24 months	Questionnaires were completed in writing by the patient. Questionnaires were administered at 1-2 months after initiation of hormonal treatment (before RT), at 3-4 months (during RT), and at 6 months after initiation of study therapy. Patients also completed questionnaires at 12, 18, and 24 months after completion of radiation therapy. Of primary interest were the baseline and 6 month and 24 month timepoints which are reported here. Scale scores could range from 0-100, with higher scores indicating better quality of life.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Free From Biochemical Failure	4 years	Increase in prostate-specific antigen (PSA) measured over time. Freedom from biochemical failure (FFBF) was defined from the time of enrollment until PSA failure occurs as defined by the Phoenix definition of a rise to 2 ng/mL above the nadir PSA value.

Recruitment & Eligibility