Degarelix, Bicalutamide, and Docetaxel before Surgery in Treating Patients with High Risk Metastatic Prostate Cancer

Inclusion Criteria

• Age 18 years or older
• Histologically confirmed adenocarcinoma of the prostate without signet cell or small cell features
• High risk prostate cancer defined as extracapsular extension (cT3a) or seminal vesicle involvement (cT3b) or invasion of adjacent structures (cT4), serum PSA > 20 ng/mL or Gleason score of 8 to 10 and/or regional lymph node or
• Oligometastatic disease defined as disseminated metastases beyond regional lymph nodes that meet the following criteria: * No visceral metastases * Less than four bony metastases
• Ability to comply with all study procedures and willingness to remain supine for 120 minutes during imaging
• Patients must be informed of the experimental nature of the study and its potential risks, and must sign an Institutional Review Board (IRB)-approved written informed consent form indicating such an understanding
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
• Patients must be considered candidates for prostatectomy as per standard of care
• Absolute neutrophil count (ANC) >= 1500/mm^3 (within 4 weeks of day 1)
• Hemoglobin (HgB) >= 10.0 gr/dL independent of transfusion (within 4 weeks of day 1)
• Platelets >= 100,000/mm^3 (within 4 weeks of day 1)
• Creatinine =< 2.0 mg/dL (within 4 weeks of day 1)
• Total bilirubin =< upper limit of normal (ULN) (within 4 weeks of day 1)
• Estimated life expectancy of >= 12 months at screening
• Throughout the study, patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) from screening through 3 months after last dose of study drug; two acceptable methods of birth control thus include the following: * A condom (barrier method of contraception) AND one of the following is required: ** Established and ongoing use of oral, injected, or implanted hormonal method of contraception by the female partner ** Placement of an intrauterine device or intrauterine system by the female partner ** Additional barrier method: Contraceptive sponge or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner ** Tubal ligation in the female partner performed at least 6 months before screening ** Vasectomy or other procedure resulting in infertility (e.g., bilateral orchiectomy), performed at least 6 months before screening
• While receiving chemotherapy, the patient must use a condom if having sex with a pregnant woman
• Must agree not to donate sperm from first dose of study drug through 3 months after the last dose of study drug

Exclusion Criteria

• Prior treatment for prostate cancer, including ADT, orchiectomy, antiandrogens, ketoconazole, abiraterone acetate or enzalutamide
• Prior radiation to the prostate
• Use of other investigational agent for prostate cancer
• No active secondary malignancy
• Total bilirubin > ULN (NOTE: in subjects with Gilbert’s syndrome, if total bilirubin is > ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible) or
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.0 x ULN or
• ALT or aspartate AST > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN
• Peripheral neuropathy grade > 1
• Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within the previous 6 months
• Major surgery within 4 weeks before screening
• Patients with known psychological or sociological conditions, addictive disorders or family problems, which would preclude compliance with the protocol
• Herbal supplements that have been shown to modulate testosterone or androgen signaling (e.g. saw palmetto) are not allowed while on study
• Subjects may not be enrolled concurrently on other treatment studies
• Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial; places the patient at undue risk; or complicates the interpretation of the data, in the opinion of the investigator or medical monitor