Neoadjuvant 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 prostate-specific antigen response of at least a 50% decrease from
baseline, will proceed to maximum consolidative therapy.
Surgery and Radiation (month 7 though ~11): After completion of neoadjuvant therapy, the men
will be treated with definitive local therapy with radical prostatectomy (RP) +/- adjuvant
radiation therapy (RT). After definitive local therapy, patients will be treated with
consolidative stereotactic body radiation therapy (SBRT) to the metastatic sites.
Follow up: Patients will continue on androgen deprivation for a total of 1 year. They will be
followed clinically and monitored with serum testosterone and prostate-specific antigen until
2-years after completion of ADT (Androgen deprivation therapy) treatment. Androgen blockade
will be the same throughout the course of treatment.
Inclusion Criteria:
- Willing and able to provide written informed consent.
- Age ≥ 18 years
- Eastern cooperative group (ECOG) performance status ≤2
- Documented histologically confirmed adenocarcinoma of the prostate
- 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 prostatectomy +/- adjuvant
radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic
lesions. Additionally, must be willing to be treated with a full year of androgen
deprivation.
- 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 positron emission tomography scan)
- Able to swallow the study drugs whole as tablets
Exclusion Criteria:
- Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation
therapy, brachytherapy)
- Prior therapy to a metastatic site.
- Prior or ongoing systemic therapy for prostate cancer including, but not limited to:
1. Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)
2. Cytochrome (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 1 year of androgen
deprivation would begin at the time of therapy initiation, rather than at study
enrollment.
- 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.
- Any psychological, familial, sociological, or geographical condition that could
potentially interfere with compliance with the study protocol and follow-up schedule.
- Abnormal bone marrow function [absolute neutrophil count (ANC)<1500/mm3, platelet
count <100,000/mm3, hemoglobin <9 g/dL]
- Abnormal liver function (bilirubin >upper limit of normal; aspartate aminotransferase
, alanine aminotransferase > 2.5 x upper limit of normal)
- Creatinine clearance of ≥ 30 mL/min. Creatinine clearance should be calculated suing
the Cockcroft-Gault formula.
- Active cardiac disease defined as active angina, symptomatic congestive heart failure,
or myocardial infarction within previous six months.
- 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.
