Cardiovascular Risk and Preventive Care in Prostate Cancer Patients Receiving Radiation and Hormone Therapy

NCT ID: NCT02003417

Last Updated: 2018-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2018-05-04

Brief Summary

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This study will evaluate the proportion of prostate cancer patients receiving external beam radiation therapy (EBRT) and androgen deprivation therapy (ADT) with controlled blood sugars (fasting glucose and hemoglobin A1c), blood pressure, and cholesterol profile (total cholesterol, LDL, HDL, triglycerides) at baseline, 3 months, and 12 months after completing radiation treatment. In addition, receipt of guideline-recommended cardiovascular, primary and preventive care as well as patient-reported quality of life and satisfaction with care among these patients will be evaluated at baseline and 12 months.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-metastatic prostate cancer patients

Histologically-confirmed, non-metastatic prostate cancer patients who received external beam radiation treatment with androgen deprivation therapy (total ADT duration \> 3 months) for definitive treatment.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Histologically-confirmed, non-metastatic prostate cancer
* Patients who will receive external beam radiation treatment with androgen deprivation therapy (total ADT duration \> 3 months) for curative treatment, either in the definitive or post-prostatectomy setting
* Patients who have a primary care provider
* Informed consent obtained and signed
* Ability to read and write English
* Age \>= 18
* No mental incompetence which would preclude completion of questionnaires

Exclusion Criteria

* Prior cancer, pelvic radiation treatment or chemotherapy
* Patients who do not have a primary care provider
* Prior ADT
* Mental incompetence which would preclude completion of questionnaires
* Unable to read and write English
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Radiation Therapy Oncology Group

NETWORK

Sponsor Role collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald C Chen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina at Chapel Hill - Department of Radiation Oncology

Locations

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Medstar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

University of North Carolina at Chapel Hill Cancer Hospital

Chapel Hill, North Carolina, United States

Site Status

High Point Regional UNC Health Care

High Point, North Carolina, United States

Site Status

Rex Healthcare, Inc

Raleigh, North Carolina, United States

Site Status

Rex Healthcare of Wakefield

Raleigh, North Carolina, United States

Site Status

Marion L. Shepard Cancer Center

Washington, North Carolina, United States

Site Status

Coastal Carolina Radiation Oncology

Wilmington, North Carolina, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Related Links

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http://unclineberger.org/

UNC Lineberger Comprehensive Cancer Center

http://www.cancer.gov/

National Cancer Institute

Other Identifiers

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LCCC 1218

Identifier Type: -

Identifier Source: org_study_id

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