Mechanisms of Metabolic and Hormone Action on Plaque Formation in Brain and Carotid Vessels in Patients With Prostate Adenocarcinoma
NCT ID: NCT03718338
Last Updated: 2020-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
2 participants
OBSERVATIONAL
2019-10-08
2020-03-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Clinical Evaluations
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.
Evaluation
Undergo clinical evaluations
Quality-of-Life Assessment
Ancillary studies
Interventions
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Evaluation
Undergo clinical evaluations
Quality-of-Life Assessment
Ancillary studies
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Evan Yu
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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9939
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2018-01618
Identifier Type: REGISTRY
Identifier Source: secondary_id
RG1001903
Identifier Type: -
Identifier Source: org_study_id