Mechanisms of Metabolic and Hormone Action on Plaque Formation in Brain and Carotid Vessels in Patients With Prostate Adenocarcinoma

Inclusion Criteria:

• Signed informed consent
• Histologically confirmed adenocarcinoma of the prostate
• Non-castrate disease with a serum testosterone level >= 50 ng/dL (1.73 nmol/L) at baseline
• No evidence of distant metastatic disease on baseline computed tomography-chest, abdomen and pelvis (CT-CAP) and bone scans

• Patients will be stratified by the presence or absence of pre-existing cardiovascular disease defined as at least one of the following:

  • Prior myocardial infarction >= 30 days before enrollment

  • Prior revascularization procedure >= 30 days before consent, including:

    • Coronary artery stent placement or balloon angioplasty
    • Coronary artery bypass graft surgery
    • Stent placement or balloon angioplasty to a carotid, iliac, femoral, or popliteal artery
    • Carotid endarterectomy surgery
    • Vascular bypass surgery of the iliac, femoral, or popliteal artery
  • Results from angiogram or CT angiogram of coronary, carotic, iliac, femoral, or popliteal arteries that documents at least one vascular stenosis >= 50% at any time point before enrollment
  • Carotid ultrasound results that shows stenosis >= 50% at any time point before enrollment
  • Ankle-brachial pressure index < 0.9 at any time point before enrollment
• Intent to initiate continuous androgen deprivation therapy (ADT) for at least 12 months

Exclusion Criteria:

• No prior treatment with ADT at time of study entry. (Prior neoadjuvant/adjuvant ADT is allowed only if the last injection of a depot formulation wore off at least 12 months prior to enrollment)
• Previous or concurrent hormonal or systemic therapy for prostate cancer including: anti-androgens, estrogens, megestrol acetate, ketoconazole, abiraterone, enzalutamide, or chemotherapy. (Prior or planned neoadjuvant bicalutamide for prevention of tumor flare is allowed)
• Plans to start or continue treatment with an investigational product after enrollment
• Poorly controlled type 1 or type 2 diabetes mellitus, based on hemoglobin A1c, as judged by the investigator
• Prior or planned surgical castration
• Poorly controlled hypertension at time of study entry, as judged by the investigator
• Myocardial infarction or stroke < 30 days prior to enrollment
• Coronary, carotid, or peripheral artery revascularization < 30 days prior to enrollment
• Planned or scheduled cardiac surgery or percutaneous coronary intervention (PCI) procedure that is known at the time of enrollment
• Mental incapacity or language barrier precluding adequate understanding or cooperation
• Inability to tolerate magnetic resonance imaging (MRI) imaging, or both Lupron and Degarelix
• Any other clinically significant disorder which may affect the subject's health or the outcome of the trial as judged by the investigator
• Estimated glomerular filtration rate (eGFR) < 45
• History of allergy to gadolinium contrast agent