Radiation and Androgen Ablation for Prostate Cancer

• Toxicity Assessment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  1) Assess the incidence of grade 3 or greater GU (genitourinary) and GI (gastrointestinal) toxicity with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.
• Quality of Life Assessment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  Assess the self-reported quality of life data with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.

• Toxicity Assessment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  1) Assess the incidence of grade 3 or greater GU and GI toxicity with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.
• Quality of Life Assessment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  Assess the self-reported quality of life data with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.

• Various Control Rate Assessments [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  Assess biochemical, clinical, and pathologic control rates associated with the combined hypofractionated dose regimen and ADT.
• Dose Volume/ Imaging Data Assessments [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  Collect dose/volume and imaging data to allow normal tissue complication probability modeling and targeting assessment for patients treated with hypofractionated radiation therapy.
• Biomarker Studies [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  Collect whole blood to perform correlative studies for serum cytokine profiling and future biomarker studies.

A study to see how effective and tolerable radiation therapy along with androgen suppression therapy is in treating prostate cancer.

This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, 2 months before and 2 months after the hypofractionated radiation delivered.

• Radiation: Radiation Therapy
  7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions)
• Drug: Androgen Suppression Therapy
  Androgen deprivation therapy (ADT) for 4 months total, 2 months before and 2 months after the hypofractionated radiation delivered.

Inclusion Criteria:

• Histologically confirmed, locally confined adenocarcinoma of the prostate
• Clinical stages T1a-T2c
• PSA of less than 20 ng/ml
• Gleason score of less than 8
• Patient must fit D'Amico intermediate risk criteria by clinical stage (T2b-T2c), PSA (prostatic specific antigen) (10-20 ng/mL), and/or Gleason score (Gleason 7).
• The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer.
• Signed study-specific consent form prior to registration

Exclusion Criteria:

• Stage T3-4 disease.
• Gleason 8 or higher score.
• PSA > 20 ng/ml.
• IPSS (International Prostate Symptom Score) > 15
• Clinical or Pathological Lymph node involvement (N1).
• Evidence of distant metastases (M1).
• Radical surgery for carcinoma of the prostate.
• Previous Chemotherapy or pelvic radiation therapy.
• Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years.
• History of inflammatory bowel disease.
• Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.
• Myocardial infarction or cerebrovascular accident within one year from consultation, or other major vascular risk factor which would prevent a patient from receiving appropriate androgen deprivation therapy.11
• Liver function tests (LFTs) greater than twice the upper limit of normal.