External Beam Radiation Therapy (EBRT) With or Without Hormonal Therapy in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Radiation Therapy; Bicalutamide; Leuprolide; Goserelin; Flutamide; Questionnaire
Intervention description: Radiation treatment given over about 8 1/2 weeks; 42 treatments, 5 days per week with 2 days rest in between.; 50 mg By Mouth (PO) Daily; 22.5 mg Intramuscularly (IM) Every 3 Months or 7.5 mg IM Every 1 Month; 10.8 mg Subcutaneously Every 3 Months or 3.6 mg Subcutaneously Every 1 Month; 250 mg by mouth three times daily on first 21-30 Days. May be used instead of Bicalutamide.; Questionnaires regarding health-related quality of life given before therapy begins, each taking about 15 minutes to complete.
Intervention MeSH terms: Leuprolide; Goserelin; Flutamide; Bicalutamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: Male
Healthy volunteers: No
Keywords: Prostate Cancer; External Beam Radiotherapy; Radiation Therapy; Hormone Therapy; Bicalutamide; Casodex; Leuprolide; Lupron; Goserelin; Zoladex; Flutamide; EBRT

Summary:

      Primary Objective:

        -  To assess the possible improvement in prostate specific antigen (PSA) outcome of short
           course androgen suppression therapy in conjunction with dose-escalation intensity
           modulated radiation therapy (IMRT), 3D conformal radiation therapy (3D-CRT), or proton
           therapy over IMRT, 3D-CRT, or proton therapy alone in prostate cancer patients
           traditionally considered at intermediate risk for PSA failure following conventional
           local therapy. PSA failure will be the primary endpoint.

      Secondary Objectives:

        -  To assess local control, freedom from distant metastasis, and overall survival.

        -  To study the impact of radiation therapy and/or hormone therapy on health-related
           quality of life measures using the Expanded Prostate Cancer Index Composite-Short Form
           12-American Urological Association Symptom Index (EPIC-SF12-AUASI:
           http://roadrunner.cancer.med.umich.edu/epic/).

        -  To assess prognostic value of pretreatment serum testosterone as well as the decrease in
           hemoglobin from neoadjuvant hormone therapy.

        -  To assess prognostic value of pretreatment biomarkers on subsequent post-treatment
           clinical outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Biopsy proven prostate cancer within last 12 months. Pathology must be reviewed at
             M.D. Anderson Cancer Center (MDACC).

          2. 1992 American Joint Committee on Cancer (AJCC) clinical stage T1c-2b on digital rectal
             exam with biopsy Gleason sum of 7 and Prostate-Specific Antigen (PSA) < 20 ng/mL (i.e.
             PSA 19.99 ng/mL or less)

          3. 1992 AJCC clinical stage T2b on physical exam with biopsy Gleason sum of 7 or less
             and/or PSA < 20 ng/ml

          4. 1992 AJCC clinical stage T1c-2b on digital rectal exam with biopsy Gleason sum of 7 or
             less and PSA > 10 but less than 20 ng/ml (i.e. 10.01-19.99 ng/mL). PSA used for
             protocol eligibility should be obtained within 30 days of protocol enrollment.

          5. No evidence of metastatic disease on bone scan within 3 months of study enrollment.

          6. No evidence of metastatic disease on pelvic computed tomography (CT) or magnetic
             resonance imaging (MRI) within 3 months of study enrollment.

          7. Zubrod performance status < 2.

          8. Must be able to understand protocol and adhere to follow-up initially at 3 months
             post-radiation and then at 6 month intervals for first two years and annually
             thereafter.

          9. Patient must be able to undergo adequate daily trans-abdominal ultrasound localization
             (B.A.T.) or other image-guided localization of the prostate during radiation course.

         10. Patients will be allowed to participate in other protocols if they are eligible and
             the other protocols do not interfere with participation in this protocol.

        Exclusion Criteria:

          1. Patients who do not meet the inclusion criteria. Specifically, patients with all the
             following features: clinical T1c-2a and Gleason sum of 6 and PSA </= 10 ng/ml.
             Patients with one or more of the following features: clinical T2c, or Gleason 8-10, or
             PSA > 20 ng/ml are not eligible.

          2. Prior androgen suppression therapy. (Prior finasteride and saw palmetto allowed but
             must be discontinued prior to enrollment. Biopsy and PSA must be documented prior to
             finasteride use.)

          3. Previous or concurrent malignancies other than basal or squamous cell skin cancers
             unless disease-free for 5 years or more.

          4. Prior pelvic radiation or chemotherapy. Patients who received chemotherapy for
             non-prostate cancer malignancies over 5 years prior will be eligible.

          5. Prior or planned radical prostate surgery.

          6. Patients with clinical evidence or biopsy-proven extracapsular extension, seminal
             vesicle involvement, or lymph node involvement will be excluded. Patients with
             radiographic evidence of nodal or bone metastasis will be excluded.

          7. Other histologies such as small cell carcinoma, sarcomatoid or ductal variants are not
             eligible.

          8. Patients with any Gleason grade 5 disease on biopsy will not be eligible.