1. Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma, at intermediate risk for recurrence, within 180 days prior to registration as determined by having one or more of the following intermediate-risk features: Gleason score 7; prostate-specific antigen (PSA) >10 but ≤20; clinical stage T2b-T2c.
  • Patients previously diagnosed with low risk (Gleason score ≤ 6,
  clinical stage < T2a, and PSA < 10) prostate cancer undergoing
  active surveillance who are re-biopsied and found to have
  intermediate risk disease according to the protocol criteria are
  eligible for enrollment within 180 days of the repeat biopsy
  procedure.

2.Clinically negative lymph nodes as established by imaging (pelvic +/- abdominal CT or MRI), nodal sampling, or dissection within 60 days prior to registration, except as noted immediately below:
  • Patients with a single intermediate risk factor only do not require
  abdominopelvic imaging, but these studies may be obtained at the
  discretion of the treating physician. Patients with 2 or 3 risk factors
  are required to undergo pelvic +/- abdominal CT or MRI.
  • Patients with lymph nodes equivocal or questionable by imaging
  are eligible without biopsy if the nodes are ≤1.5 cm; any node
   larger than this on imaging will require negative biopsy for
  eligibility.

3. No evidence of bone metastases (M0) on bone scan within 60 days prior to registration.
  • Bone scan is not required for patients enrolled with a single
  intermediate risk factor only, but this scan may be obtained at the
  discretion of the treating physician. Patients with 2 or 3 risk factors
  will require a negative bone scan for eligibility.
  • Equivocal bone scan findings are allowed if plain film x-rays are
  negative for metastasis.

4. History/physical examination (to include, at a minimum, digital rectal examination of the prostate and examination of the skeletal system and abdomen, and formal comorbidity assessment via the ACE-27 instrument) within 60 days prior to registration.

5. Zubrod Performance Status 0-1

6. Age ≥ 18

7. Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 60 days prior to registration
  o Study entry PSA must not be obtained during the following time
  frames: (1) 10-day period following prostate biopsy; (2) following
  initiation of ADT; (3) within 30 days after discontinuation of
  finasteride; or (4) within 90 days after discontinuation of
  dutasteride.

8. For patients undergoing brachytherapy only: complete blood count (CBC)/differential obtained within 60 days prior to registration, with adequate bone marrow function defined as follows:
  • Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
  • Platelets ≥ 100,000 cells/mm3
  • Hemoglobin (Hgb) ≥ 8.0 g/dl (Note: The use of transfusion or
  • Other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)

9. Patient must be able to provide study-specific informed consent prior to study entry.

1. Patients with Gleason Score ≥ 8; PSA > 20; OR Clinical Stage ≥ T3 are ineligible for this trial.
  • Should findings of extracapsular extension or seminal vesicle
  invasion be noted on prostate MRI, this study, if used, will not
  render patients ineligible for accrual to this protocol. Primary tumor
  staging for eligibility purposes is to be based on palpable or core
  biopsy evidence only with respect to extracapsular extension or
  seminal vesicle involvement.

2. Patients with all three intermediate risk factors who also have ≥ 50% of the number of their biopsy cores positive for cancer are ineligible for this trial.

3. Prior invasive malignancy (except non-melanomatous skin cancer) or hematological (e.g., leukemia, lymphoma, myeloma) malignancy unless disease free for a minimum of 5 years (prior diagnoses of carcinoma in situ are permitted)

4. Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer

5. Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy

6. Use of finasteride within 30 days prior to registration

7. Use of dutasteride within 90 days prior to registration

8. Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy for a different cancer is permitted.

9. Prior RT, including brachytherapy, to the region of the study cancer that would result in overlap of RT fields

  • Any patient undergoing brachytherapy must have transrectal
  ultrasound confirmation of prostate volume <60 cc, American
  Urological Association Symptom Index (AUA-SI) score ≤15 within
  60 days of registration, and no history of prior transurethral
  resection of the prostate (TURP); prior TURP is permitted for
  patients who receive EBRT only)

10. Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring
  hospitalization within the last 6 months
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous
  antibiotics at the time of registration
  • Chronic Obstructive Pulmonary Disease exacerbation or other
  respiratory illness requiring hospitalization or precluding study
  therapy within 30 days before registration
  • Hepatic insufficiency resulting in clinical jaundice and/or
  coagulation defects; note, however, that laboratory tests for liver
  function and coagulation parameters are not required for entry into
  this protocol.
  • Acquired Immune Deficiency Syndrome (AIDS) based upon
  current Centers for Disease Control and Prevention (CDC)
  definition; note, however, that HIV testing is not required for entry
  into this protocol. While the treatment employed in this study is not   
  significantly immunosuppressive, it is felt that a diagnosis of AIDS
  associated with prostate cancer is likely to impact this study's
  primary endpoint of overall survival. Patients who are HIV
  seropositive but do not meet criteria for diagnosis of AIDS are
  eligible for study participation.

11. Men who are sexually active with a woman of child-bearing potential and not willing/able to use medically acceptable forms of contraception (e.g., surgical, barrier, medicinal) during protocol treatment and during the first 3 months after cessation of protocol treatment; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.

• stage IIB prostate cancer,

• adenocarcinoma of the prostate,

• stage IIA prostate cancer,

• Androgen Antagonists

• Androgens

• Antineoplastic Agents

• Antineoplastic Agents, Hormonal

• Bicalutamide

• Buserelin

• Contraceptive Agents

• Contraceptive Agents, Female

• Contraceptive Agents, Hormonal

• Fertility Agents

• Fertility Agents, Female

• Flutamide

• Genital Diseases

• Genital Diseases, Male

• Genital Neoplasms, Male

• Goserelin

• Hormone Antagonists

• Hormones

• Hormones, Hormone Substitutes, and Hormone Antagonists

• Leuprolide

• Luteolytic Agents

• Male Urogenital Diseases

• Neoplasms

• Neoplasms by Site

• Physiological Effects of Drugs

• Prostatic Diseases

• Prostatic Neoplasms

• Reproductive Control Agents

• Triptorelin Pamoate

• Urogenital Diseases

• Urogenital Neoplasms

• Oncology (Adult)

• Urology

• Radiation Therapy Oncology Group