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NCT Number: NCT02003417

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Medstar Georgetown University Hospital, Washington D.C., District of Columbia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.

    Time frame: Baseline

    Blood sugars include fasting glucose and hemoglobin A1c; blood pressure includes systolic and diastolic; and cholesterol profile includes total cholesterol, LDL, HDL, and triglycerides. Baseline is prior to receiving androgen deprivation therapy and prior to radiation.

Secondary outcomes

  1. Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.

    Time frame: 3 months post radiation treatment completion

    Blood sugars include fasting glucose and hemoglobin A1c; blood pressure includes systolic and diastolic; and cholesterol profile includes total cholesterol, LDL, HDL, and triglycerides.

  2. Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.

    Time frame: 12 months post radiation treatment completion

    Blood sugars include fasting glucose and hemoglobin A1c; blood pressure includes systolic and diastolic; and cholesterol profile includes total cholesterol, LDL, HDL, and triglycerides.

  3. Proportion of prostate cancer patients with guideline-recommended cardiovascular preventive care (glucose testing, cholesterol testing, and blood pressure measurement).

    Time frame: Baseline

    This will be done by patient self-report and by medical record review (radiation oncologist will obtain medical records from patient's primary care physician).

  4. Proportion of prostate cancer patients with guideline-recommended cardiovascular preventive care (glucose testing, cholesterol testing, and blood pressure measurement).

    Time frame: 12 months post radiation treatment completion

    This will be done by patient self-report and by medical record review (radiation oncologist will obtain medical records from patient's primary care physician).

  5. Proportion of prostate cancer patients who receive other (non-cardiovascular) guideline-recommended primary and preventive care (flu vaccination, colorectal cancer screening, and healthy lifestyle counseling).

    Time frame: Baseline

    This will be done by patient self-report and by medical record review (radiation oncologist will obtain medical records from patient's primary care physician).

  6. Proportion of prostate cancer patients who receive other (non-cardiovascular) guideline-recommended primary and preventive care (flu vaccination, colorectal cancer screening, and healthy lifestyle counseling).

    Time frame: 12 months post radiation treatment completion

    This will be done by patient self-report and by medical record review (radiation oncologist will obtain medical records from patient's primary care physician).

  7. Patient-reported quality of life.

    Time frame: Baseline

  8. Patient-reported quality of life.

    Time frame: 12 months post radiation treatment completion

  9. Patient-reported coordination of care.

    Time frame: Baseline

  10. Patient-reported coordination of care.

    Time frame: 12 months post radiation treatment completion

  11. Patient-reported satisfaction with care.

    Time frame: Baseline

  12. Patient-reported satisfaction with care.

    Time frame: 12 months post radiation treatment completion

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • Radiation Therapy Oncology Group

Registry information

Official study title

A Multicenter Study to Evaluate Cardiovascular Risk Factors and Receipt of Primary and Preventive Care in Prostate Cancer Patients Who Receive Definitive Radiation Therapy and Androgen Deprivation Therapy.

Important dates

Study start
2012
Primary completion
2016
Study completion
2018
First posted
Dec 6, 2013
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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