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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03718338
Recruitment Status : Suspended (COVID19 Suspension)
First Posted : October 24, 2018
Last Update Posted : June 18, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Tracking Information
First Submitted Date September 12, 2018
First Posted Date October 24, 2018
Last Update Posted Date June 18, 2020
Actual Study Start Date October 8, 2019
Estimated Primary Completion Date July 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 22, 2018)
  • Change in visual characterization of 18F-florbetapir (Amyvid) positron emission tomography (PET) scans results after Andorgen Deprivation Therapy [ Time Frame: 12 Months ]
    Change From Baseline visual characterization scan results at 12 months
  • Change standardized uptake values of 18F-florbetapir (Amyvid) positron emission tomography (PET) scans results [ Time Frame: 12 Months ]
    Change from baseline standardized uptake values in select regions of interest at 12 months
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 22, 2018)
  • Cognitive test results: Story recall [ Time Frame: 12 months ]
    Change in baseline Story Recall results at 12 months
  • Cognitive Test Results: Change in Montreal Cognitive Assessment (MOCA) [ Time Frame: 12 Months ]
    Change in baseline MOCA score results at 12 months
  • Cognitive Test Results: Change in Clinical Dementia Rating Scale [ Time Frame: 12 Months ]
    Change in baseline Clinical Dementia Rating Scale score at 12 months
  • Cognitive Test Results: Digit span [ Time Frame: 12 Months ]
    Change in baseline Digit span results at 12 months
  • Cognitive Test Results: Letter number sequencing [ Time Frame: 12 Months ]
    Change in baseline Letter number sequencing results at 12 months
  • Cognitive Test Results: Stroop Test Results [ Time Frame: 12 Months ]
    Change in baseline Stroop Test Results at 12 months
  • Cognitive Test Results: Symbol Digit Modalities Test [ Time Frame: 12 Months ]
    Change in baseline Symbol Digit Modalities Test score at 12 months
  • Cognitive Test Results: Visuo-Spatial Learning Test [ Time Frame: 12 Months ]
    Change in baseline Visuo-Spatial Learning Test results at 12 months
  • Cognitive Test Results: Rey auditory verbal learning test (RVLT) [ Time Frame: 12 Months ]
    Change in baseline Rey auditory verbal learning test (RVLT) score at 12 months
  • Inflammatory and immune markers: Change in CRP [ Time Frame: 12 Months ]
    Change in baseline CRP values at 12 months
  • Inflammatory and immune markers: Change in IGFBP3 [ Time Frame: 12 Months ]
    Change in baseline IGFBP3 at 12 months
  • Inflammatory and immune markers: Change in IGFBP1 [ Time Frame: 12 Months ]
    Change in baseline IGFBP1 at 12 months
  • Inflammatory and immune markers: Change in IGF-1 [ Time Frame: 12 Months ]
    Change in baseline IGF-1 at 12 months
  • Inflammatory and immune markers: Change in IL-6 [ Time Frame: 12 Months ]
    Change in baseline IL-6 at 12 months
  • Metabolic Markers: Change in HgbA1C [ Time Frame: 12 Months ]
    Change in baseline HgbA1C at 12 months
  • Metabolic Markers: Change in Estradiol [ Time Frame: 12 Months ]
    Change in baseline Estradiol at 12 months
  • Metabolic Markers: Change in Follicle Stimulating Hormone (FSH) [ Time Frame: 12 Months ]
    Change in baseline Change in Follicle Stimulating Hormone (FSH) at 12 months
  • Metabolic Markers: Change in Leptin [ Time Frame: 12 Months ]
    Change in baseline Leptin at 12 months
  • Metabolic Markers: Change in Adiponectin [ Time Frame: 12 Months ]
    Change in baseline Adiponectin at 12 months
  • Metabolic Markers: Change in homeostatic model assessment of insulin resistance (HOMA-IR) [ Time Frame: 12 Months ]
    Change in baseline HOMA-IR values at 12 months; Calculated based on fasting glucose and insulin test results.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mechanisms of Metabolic and Hormone Action on Plaque Formation in Brain and Carotid Vessels in Prostate Adenocarcinoma
Official Title Mechanisms of Metabolic and Hormone Action on Plaque Formation in Brain and Carotid Vessels in Men Undergoing Androgen Deprivation Therapy
Brief Summary This trial studies the mechanisms of metabolic and hormone action on plaque formation in brain and carotid vessels in participants 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 Participants undergo clinical evaluations over 12 months including physical exam and vital signs, waist to hip circumference, electrocardiograms, medical history and events, laboratory evaluations, imaging evaluations, cognitive function evaluations, gait assessment, and quality of life questionnaires.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, urine
Sampling Method Non-Probability Sample
Study Population Participants with prostate adenocarcinoma
Condition Prostate Adenocarcinoma
Intervention
  • Procedure: Evaluation
    Undergo clinical evaluations
  • Other: Quality-of-Life Assessment
    Ancillary studies
Study Groups/Cohorts Clinical Evaluations
Participants undergo clinical evaluations over 12 months including physical exam and vital signs, waist to hip circumference, electrocardiograms, medical history and events, laboratory evaluations, imaging evaluations, cognitive function evaluations, gait assessment, and Quality-of-life assessment.
Interventions:
  • Procedure: Evaluation
  • Other: Quality-of-Life Assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: October 22, 2018)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 25, 2022
Estimated Primary Completion Date July 25, 2021   (Final data collection date for primary outcome measure)
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 or undetectable/stable prostate specific antigen (PSA) for > 2 years from definitive therapy in control group
  • Patients will be stratified by the presence of 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
  • Subjects on ADT Group only: Intent to initiate continuous androgen deprivation therapy (ADT) for at least 12 months
  • Subjects on Control Group only: No intention to initiate androgen deprivation therapy (ADT) within the 13 months after enrollment
  • Subjects on Control Group only: Undetectable PSA after radical prostatectomy or stable PSA after any form of radiation as defined by principal investigator or primary oncologist

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 amyloid positron emission tomography (PET) imaging, magnetic resonance imaging (MRI) imaging, Lupron, or Degarelix
  • Any other clinically significant disorder which may affect the subject's health or the outcome of the trial as judged by the investigator
Sex/Gender
Sexes Eligible for Study: Male
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03718338
Other Study ID Numbers RG1001903
9939 ( Other Identifier: FHCRC )
NCI-2018-01618 ( Registry Identifier: CTRP )
5P30CA015704 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Washington
Study Sponsor University of Washington
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Celestia Higano Universioty of Washington
PRS Account University of Washington
Verification Date December 2019