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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

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.

Condition or disease Intervention/treatment
Prostate Adenocarcinoma Procedure: Evaluation Other: Quality-of-Life Assessment

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Mechanisms of Metabolic and Hormone Action on Plaque Formation in Brain and Carotid Vessels in Men Undergoing Androgen Deprivation Therapy
Actual Study Start Date : October 8, 2019
Estimated Primary Completion Date : July 25, 2021
Estimated Study Completion Date : July 25, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Group/Cohort Intervention/treatment
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.
Procedure: Evaluation
Undergo clinical evaluations

Other: Quality-of-Life Assessment
Ancillary studies




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Cognitive test results: Story recall [ Time Frame: 12 months ]
    Change in baseline Story Recall results at 12 months

  2. Cognitive Test Results: Change in Montreal Cognitive Assessment (MOCA) [ Time Frame: 12 Months ]
    Change in baseline MOCA score results at 12 months

  3. Cognitive Test Results: Change in Clinical Dementia Rating Scale [ Time Frame: 12 Months ]
    Change in baseline Clinical Dementia Rating Scale score at 12 months

  4. Cognitive Test Results: Digit span [ Time Frame: 12 Months ]
    Change in baseline Digit span results at 12 months

  5. Cognitive Test Results: Letter number sequencing [ Time Frame: 12 Months ]
    Change in baseline Letter number sequencing results at 12 months

  6. Cognitive Test Results: Stroop Test Results [ Time Frame: 12 Months ]
    Change in baseline Stroop Test Results at 12 months

  7. Cognitive Test Results: Symbol Digit Modalities Test [ Time Frame: 12 Months ]
    Change in baseline Symbol Digit Modalities Test score at 12 months

  8. Cognitive Test Results: Visuo-Spatial Learning Test [ Time Frame: 12 Months ]
    Change in baseline Visuo-Spatial Learning Test results at 12 months

  9. 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

  10. Inflammatory and immune markers: Change in CRP [ Time Frame: 12 Months ]
    Change in baseline CRP values at 12 months

  11. Inflammatory and immune markers: Change in IGFBP3 [ Time Frame: 12 Months ]
    Change in baseline IGFBP3 at 12 months

  12. Inflammatory and immune markers: Change in IGFBP1 [ Time Frame: 12 Months ]
    Change in baseline IGFBP1 at 12 months

  13. Inflammatory and immune markers: Change in IGF-1 [ Time Frame: 12 Months ]
    Change in baseline IGF-1 at 12 months

  14. Inflammatory and immune markers: Change in IL-6 [ Time Frame: 12 Months ]
    Change in baseline IL-6 at 12 months

  15. Metabolic Markers: Change in HgbA1C [ Time Frame: 12 Months ]
    Change in baseline HgbA1C at 12 months

  16. Metabolic Markers: Change in Estradiol [ Time Frame: 12 Months ]
    Change in baseline Estradiol at 12 months

  17. Metabolic Markers: Change in Follicle Stimulating Hormone (FSH) [ Time Frame: 12 Months ]
    Change in baseline Change in Follicle Stimulating Hormone (FSH) at 12 months

  18. Metabolic Markers: Change in Leptin [ Time Frame: 12 Months ]
    Change in baseline Leptin at 12 months

  19. Metabolic Markers: Change in Adiponectin [ Time Frame: 12 Months ]
    Change in baseline Adiponectin at 12 months

  20. 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.


Biospecimen Retention:   Samples With DNA
Blood, urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with prostate adenocarcinoma
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718338


Locations
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United States, Washington
Fred Hutch/University of Washington
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Celestia Higano Universioty of Washington
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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT03718338    
Other Study ID Numbers: RG1001903
9939 ( Other Identifier: FHCRC )
NCI-2018-01618 ( Registry Identifier: CTRP )
5P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases