A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy

Adjuvant treatment (month 1 through ~6): All patients will be treated with up to 6 months of
androgen deprivation, plus up to 6 cycles of docetaxel chemotherapy. Following docetaxel
therapy, patients with a PSA response of at least a 50% decrease from baseline, will proceed
to maximum consolidative therapy.

Local consolidation (month 7 though ~11): After completion of adjuvant chemotherapy, the men
will be treated with definitive local therapy with adjuvant radiation therapy (RT). After
definitive local therapy, patients will be treated with consolidative stereotactic body
radiation therapy (SBRT) to the metastatic sites (if present).

Systemic consolidation: Patients will continue on androgen deprivation for a total of 2
years. They will be followed clinically and monitored with serum testosterone and PSA until
2-years after completion of systemic consolidation. Androgen blockade will be the same
throughout the course of treatment.

Inclusion Criteria:

1. Willing and able to provide written informed consent.

2. Age ≥ 18 years

3. Eastern cooperative group (ECOG) performance status ≤2

4. Documented histologically confirmed adenocarcinoma of the prostate

5. Willing to undergo the following therapy: (1st) Systemic chemo-hormonal therapy with
up to 6-months (~24 weeks) of neoadjuvant androgen deprivation and up to 6 cycles of
chemotherapy, (2nd) definitive local tumor control with adjuvant radiation therapy,
and (3rd) consolidative stereotactic radiation to oligometastatic lesions.
Additionally, must be willing to be treated with a full two years of androgen
deprivation.

6. Oligometastatic prostate cancer: Stage T1-4, N0-1 and/or M1a-b (up to 5 metastatic
lesions- including bone lesions and non-regional lymph nodes seen on bone scan,
contrast enhanced CT scan, or PET scan)

Exclusion Criteria:

1. Prior local non-surgical therapy to treat prostate cancer (e.g. radiation therapy,
brachytherapy)

2. Prior therapy to a metastatic site.

3. Prior or ongoing systemic therapy for prostate cancer including, but not limited to:

1. Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)

2. CYP-17 inhibitors (e.g. ketoconazole)

3. Antiandrogens (e.g. bicalutamide, nilutamide)

4. Second generation antiandrogens (e.g. enzalutamide, abiraterone)

5. Immunotherapy (e.g. sipuleucel-T, ipilimumab)

6. Chemotherapy (e.g. docetaxel, cabazitaxel) *Note: may be enrolled if hormone
therapy was recently initiated (<90 days duration)). In the event that hormone
therapy was initiated prior to study enrollment, the clock for 2 years of
androgen deprivation would begin at the time of therapy initiation, rather than
at study enrollment.

4. Evidence of serious and/or unstable pre-existing medical, psychiatric or other
condition (including laboratory abnormalities) that could interfere with patient
safety or provision of informed consent to participate in this study.

5. Any psychological, familial, sociological, or geographical condition that could
potentially interfere with compliance with the study protocol and follow-up schedule.

6. Abnormal bone marrow function [absolute neutrophil count (ANC)<1500/mm3, platelet
count <100,000/mm3, hemoglobin <9 g/dL]

7. Abnormal liver function (bilirubin >ULN; AST, ALT > 2.5 x upper limit of normal)

8. Creatinine clearance of ≥ 30 mL/min. CrCl should be calculated suing the
Cockcroft-Gault formula.

9. Active cardiac disease defined as active angina, symptomatic congestive heart failure,
or myocardial infarction within previous six months.

10. Prior history of malignancy in the past 3 years with the exception of basal cell and
squamous cell carcinoma of the skin. Other malignancies that are considered to have a
low potential to progress may be enrolled at discretion of PI.