Clinical trial NCT03718338: Mechanisms of Metabolic and Hormone Action on Plaque Formation in Brain and Carotid Vessels in Patients With Prostate Adenocarcinoma
Official title: Mechanisms of Metabolic and Hormone Action on Plaque Formation in Brain and Carotid Vessels in Men Undergoing Androgen Deprivation Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Adenocarcinoma
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-10-24
Enrollment: 2
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with prostate adenocarcinoma

Brief summary: This trial studies the mechanisms of metabolic and hormone action on plaque formation in brain and carotid vessels in patients with prostate adenocarcinoma. Studying the biomarkers in the laboratory may help doctors know the impact of androgen deprivation on metabolic, brain and cardiovascular endpoints.

Detailed description: OUTLINE:

Patients undergo clinical evaluations over 12 months including physical exam and vital signs, waist to hip circumference, medical history and events, laboratory evaluations, imaging evaluations, cognitive function evaluations, gait assessment, and quality of life questionnaires.

Eligibility criteria: 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

Primary outcomes:
measure: Change in visual characterization of 18F-florbetapir (Amyvid) positron emission tomography (PET) scans results after Andorgen Deprivation Therapy
timeFrame: 12 Months
measure: Change standardized uptake values of 18F-florbetapir (Amyvid) positron emission tomography (PET) scans results
timeFrame: 12 Months
Secondary outcomes:
measure: Cognitive test results: Story recall
timeFrame: 12 months
measure: Cognitive Test Results: Change in Montreal Cognitive Assessment (MOCA)
timeFrame: 12 Months
measure: Cognitive Test Results: Change in Clinical Dementia Rating Scale
timeFrame: 12 Months
measure: Cognitive Test Results: Digit span
timeFrame: 12 Months
measure: Cognitive Test Results: Letter number sequencing
timeFrame: 12 Months
measure: Cognitive Test Results: Stroop Test Results
timeFrame: 12 Months
measure: Cognitive Test Results: Symbol Digit Modalities Test
timeFrame: 12 Months
measure: Cognitive Test Results: Visuo-Spatial Learning Test
timeFrame: 12 Months
measure: Cognitive Test Results: Rey auditory verbal learning test (RVLT)
timeFrame: 12 Months
measure: Inflammatory and immune markers: Change in CRP
timeFrame: 12 Months
measure: Inflammatory and immune markers: Change in IGFBP3
timeFrame: 12 Months
measure: Inflammatory and immune markers: Change in IGFBP1
timeFrame: 12 Months
measure: Inflammatory and immune markers: Change in IGF-1
timeFrame: 12 Months
measure: Inflammatory and immune markers: Change in IL-6
timeFrame: 12 Months
measure: Metabolic Markers: Change in HgbA1C
timeFrame: 12 Months
measure: Metabolic Markers: Change in Estradiol
timeFrame: 12 Months
measure: Metabolic Markers: Change in Follicle Stimulating Hormone (FSH)
timeFrame: 12 Months
measure: Metabolic Markers: Change in Leptin
timeFrame: 12 Months
measure: Metabolic Markers: Change in Adiponectin
timeFrame: 12 Months
measure: Metabolic Markers: Change in homeostatic model assessment of insulin resistance (HOMA-IR)
timeFrame: 12 Months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Evan Yu
role: PRINCIPAL_INVESTIGATOR
References: