a study of definitive therapy to treat prostate cancer

Conditions: Prostate Cancer

Summary: to assess the safety of treating men with oligometastatic prostate cancer with 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. the men will receive a total of 1 year of androgen deprivation. androgen blockade will be the same throughout the course of treatment.

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.

Eligibility criteria:
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.

Keywords: lupron bicalutamide docetaxel