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Prostate AdenocarcinomaNCT03718338

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

An observational study of Prostate Adenocarcinoma, run by University of Washington at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, men only
Conditions the study is for
Prostate Adenocarcinoma
What is being tested?
Evaluation and Quality-of-Life Assessment
Type of treatment
Surgery or procedure
How many people
2 participants
Where
1 siteUnited States
Study dates
8 Oct 2019to 12 Mar 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Participants with prostate adenocarcinoma

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Mechanisms of Metabolic and Hormone Action on Plaque Formation in Brain and Carotid Vessels in Men Undergoing Androgen Deprivation Therapy

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.

Read the detailed 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.

Being tested
Evaluation, Quality-of-Life Assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EvaluationProcedure or surgery

    Undergo clinical evaluations

  • Quality-of-Life AssessmentOther

    Ancillary studies

Study groups in NCT03718338
Study groupRoleWhat they receive
Clinical EvaluationsPatients 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.
Receives: Procedure: Evaluation; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 Months

  2. 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

    Measured: 12 Months

Secondary outcomes (20)

  1. Cognitive test results: Story recall

    Change in baseline Story Recall results at 12 months

    Measured: 12 months

  2. Cognitive Test Results: Change in Montreal Cognitive Assessment (MOCA)

    Change in baseline MOCA score results at 12 months

    Measured: 12 Months

  3. Cognitive Test Results: Change in Clinical Dementia Rating Scale

    Change in baseline Clinical Dementia Rating Scale score at 12 months

    Measured: 12 Months

  4. Cognitive Test Results: Digit span

    Change in baseline Digit span results at 12 months

    Measured: 12 Months

  5. Cognitive Test Results: Letter number sequencing

    Change in baseline Letter number sequencing results at 12 months

    Measured: 12 Months

  6. Cognitive Test Results: Stroop Test Results

    Change in baseline Stroop Test Results at 12 months

    Measured: 12 Months

  7. Cognitive Test Results: Symbol Digit Modalities Test

    Change in baseline Symbol Digit Modalities Test score at 12 months

    Measured: 12 Months

  8. Cognitive Test Results: Visuo-Spatial Learning Test

    Change in baseline Visuo-Spatial Learning Test results at 12 months

    Measured: 12 Months

  9. Cognitive Test Results: Rey auditory verbal learning test (RVLT)

    Change in baseline Rey auditory verbal learning test (RVLT) score at 12 months

    Measured: 12 Months

  10. Inflammatory and immune markers: Change in CRP

    Change in baseline CRP values at 12 months

    Measured: 12 Months

  11. Inflammatory and immune markers: Change in IGFBP3

    Change in baseline IGFBP3 at 12 months

    Measured: 12 Months

  12. Inflammatory and immune markers: Change in IGFBP1

    Change in baseline IGFBP1 at 12 months

    Measured: 12 Months

  13. Inflammatory and immune markers: Change in IGF-1

    Change in baseline IGF-1 at 12 months

    Measured: 12 Months

  14. Inflammatory and immune markers: Change in IL-6

    Change in baseline IL-6 at 12 months

    Measured: 12 Months

  15. Metabolic Markers: Change in HgbA1C

    Change in baseline HgbA1C at 12 months

    Measured: 12 Months

  16. Metabolic Markers: Change in Estradiol

    Change in baseline Estradiol at 12 months

    Measured: 12 Months

  17. Metabolic Markers: Change in Follicle Stimulating Hormone (FSH)

    Change in baseline Change in Follicle Stimulating Hormone (FSH) at 12 months

    Measured: 12 Months

  18. Metabolic Markers: Change in Leptin

    Change in baseline Leptin at 12 months

    Measured: 12 Months

  19. Metabolic Markers: Change in Adiponectin

    Change in baseline Adiponectin at 12 months

    Measured: 12 Months

  20. Metabolic Markers: Change in homeostatic model assessment of insulin resistance (HOMA-IR)

    Change in baseline HOMA-IR values at 12 months; Calculated based on fasting glucose and insulin test results.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2018
  2. Study start8 Oct 2019
  3. Primary completion12 Mar 2020
  4. Study completion12 Mar 2020

Why it stopped: Terminated due to low accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03718338
Sponsor's protocol ID
RG1001903
Other IDs
9939, NCI-2018-01618, 5P30CA015704
Status last verified
Dec 2020
First submitted
12 Sep 2018
Last updated
10 Dec 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Adenocarcinoma, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Terminated due to low accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in visual characterization of 18F-florbetapir (Amyvid) positron emission tomography (PET) scans results after Andorgen Deprivation Therapy (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03718338.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.

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