A Study of Definitive Therapy to Treat Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Leuprolide Acetate; Bicalutamide; Docetaxel; Prostatectomy; Radiation
Intervention description: 22.5mg by intramuscular (IM) injection every 3 months; bicalutamide (Casodex) 50mg by mouth daily; Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles.; Removal of the entire prostate gland, plus some surrounding tissue.; 5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites.
Intervention MeSH terms: Docetaxel; Leuprolide; Bicalutamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Lupron; Bicalutamide; Docetaxel

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.
    

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.