Stereotactic Boost and Long-Term Androgen Deprivation for Adenocarcinoma of the Prostate

The primary objective of this study is to assess the feasibility and safety of a treatment
strategy incorporating whole pelvic IMRT followed by an SBRT boost to the prostate with
neoadjuvant, concurrent, and adjuvant androgen deprivation for a total of 28 months for men
with unfavorable intermediate or high risk localized prostate cancer.

The secondary objective is to assess biochemical control at 24 months following the
experimental treatment strategy by the "Phoenix definition". Patients not meeting these
prostate-specific antigen (PSA) criteria (Phoenix Definition) for failure who undergo salvage
therapies (such as androgen deprivation therapy (ADT), radical prostatectomy or
brachytherapy, or Cryosurgery) should also be declared as failures at the time a positive
biopsy is obtained or salvage therapy is administered, whichever comes first.

Another secondary objective is to assess toxicity of the experimental treatment approach as
scored by the Common Terminology Criteria for Adverse Events The third secondary objective is
to assess prostate organ motion during hypofractionated radiotherapy. To assess motion of the
prostate during the protracted delivery of hypofractionated radiotherapy as assessed by
implanted electromagnetic transponder beacons.

Inclusion Criteria:

1. Pathologically (histologically or cytologically) proven diagnosis of prostatic
adenocarcinoma within 180 days of registration at moderate to high risk for recurrence

2. History/physical examination (to include at a minimum digital rectal examination of
the prostate and examination of the skeletal system and abdomen) within 90 days prior
to registration.

3. Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or
MRI), (but not by nodal sampling, or dissection) within 90 days prior to registration.

4. Patients with lymph nodes equivocal or questionable by imaging are eligible if the
nodes are ≤ 2.0 cm.

5. No evidence of bone metastases (M0) on bone scan within 90 days prior to registration.

6. Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative
for metastasis.

7. Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott,
Hybritech) within 12 weeks (90 days) prior to registration.

8. Study entry PSA should not be obtained during the following time frames: (1) 10-day
period following prostate biopsy; (2) following initiation of hormonal therapy; (3)
within 30 days after discontinuation of finasteride; (4) within 90 days after
discontinuation of dutasteride.

9. Zubrod Performance Status 0-2

10. Complete blood count (CBC)/differential obtained within 2 weeks (14 days) prior to
registration on study, with adequate bone marrow function

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

Exclusion Criteria:

1. Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a
minimum of 2 years.

2. Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer

3. Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy

4. Previous hormonal therapy

5. Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset
of androgen ablation is ≤ 60 days prior to the date of registration.

6. Use of finasteride within 30 days prior to registration

7. Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to
registration

8. Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior
chemotherapy for a different cancer is allowable. See Section 3.2.1.

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

10. Severe, active co-morbidity including heart issues, infection and liver problems

11. Patients who are sexually active and not willing/able to use medically acceptable
forms of contraception

12. Prior allergic reaction to the hormones involved in this protocol

13. Patients status-post a negative lymph node dissection are not eligible