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

University of Washington

Status: Terminated

Conditions: Prostate Adenocarcinoma

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03718338

NCI-2018-01618 (Registry Identifier)

5P30CA015704 (U.S. NIH Grant/Contract)

9939 (Other Identifier)

RG1001903

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

2 participants in 1 patient group

Clinical Evaluations

Description:

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.

Treatment:

Procedure: Evaluation

Other: Quality-of-Life Assessment