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

NCT03718338 | Terminated

• 4 other identifiers: RG10019039939NCI-2018-016185P30CA015704
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Change in visual characterization of 18F-florbetapir (Amyvid) positron emission tomography (PET) scans results after Andorgen Deprivation Therapy

  Change From Baseline visual characterization scan results at 12 months

  12 Months

• Change standardized uptake values of 18F-florbetapir (Amyvid) positron emission tomography (PET) scans results

  Change from baseline standardized uptake values in select regions of interest at 12 months

  12 Months

Secondary Outcomes (20)

• Cognitive test results: Story recall

  12 months

• Cognitive Test Results: Change in Montreal Cognitive Assessment (MOCA)

  12 Months

• Cognitive Test Results: Change in Clinical Dementia Rating Scale

  12 Months

• Cognitive Test Results: Digit span

  12 Months

• Cognitive Test Results: Letter number sequencing

  12 Months

Study Arms (1)

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.

Procedure: Evaluation; Other: Quality-of-Life Assessment

Interventions

Evaluation PROCEDURE

Undergo clinical evaluations

Clinical Evaluations

Quality-of-Life Assessment OTHER

Ancillary studies

Clinical Evaluations

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with prostate adenocarcinoma

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington

Seattle, Washington, 98109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine

Study Officials

• Evan Yu

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: October 24, 2018
• Study Start: October 8, 2019
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: December 10, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)