A Study of Definitive Therapy to Treat Prostate Cancer (oligo-mets)

This is an interventional treatment trial for Prostate Cancer focused on measuring Lupron, Bicalutamide, Docetaxel Read More

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.