Prostate CancerNCT02003417
Cardiovascular Risk and Preventive Care in Prostate Cancer Patients Receiving Radiation and Hormone Therapy
An observational study of Prostate Cancer, run by UNC Lineberger Comprehensive Cancer Center at 8 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 101 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2012to 4 May 2018
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Histologically-confirmed, non-metastatic prostate cancer patients who visit radiation oncology clinics at participating institutions: The University of North Carolina at Chapel Hill Cancer Hospital, Rex Cancer Center at the Raleigh and Wakefield locations, Marion J. Shepard Cancer Center, Coastal Carolina Radiation Oncology, The University of Virginia, High Point Regional UNC Health Care, and MedStar Georgetown University. Patients with planned radiation treatment and androgen deprivation therapy with curative intent (in definitive or post-prostatectomy settings) are eligible.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of North Carolina at Chapel Hill Cancer Hospital
Chapel Hill, North Carolina, 27599
University of Virginia
Charlottesville, Virginia, 22908
High Point Regional UNC Health Care
High Point, North Carolina, 27262
Rex Healthcare, Inc
Raleigh, North Carolina, 27607
Rex Healthcare of Wakefield
Raleigh, North Carolina, 27614
Marion L. Shepard Cancer Center
Washington, North Carolina, 27889
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Coastal Carolina Radiation Oncology
Wilmington, North Carolina, 28401
About this study
Official 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.
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.
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, External beam radiation treatment, Androgen deprivation therapy, Definitive treatment, Cardiovascular risk factors, Quality of life
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.
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.
Measured: Baseline
Secondary outcomes (12)
Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.
Blood sugars include fasting glucose and hemoglobin A1c; blood pressure includes systolic and diastolic; and cholesterol profile includes total cholesterol, LDL, HDL, and triglycerides.
Measured: 3 months post radiation treatment completion
Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.
Blood sugars include fasting glucose and hemoglobin A1c; blood pressure includes systolic and diastolic; and cholesterol profile includes total cholesterol, LDL, HDL, and triglycerides.
Measured: 12 months post radiation treatment completion
Proportion of prostate cancer patients with guideline-recommended cardiovascular preventive care (glucose testing, cholesterol testing, and blood pressure measurement).
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).
Measured: Baseline
Proportion of prostate cancer patients with guideline-recommended cardiovascular preventive care (glucose testing, cholesterol testing, and blood pressure measurement).
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).
Measured: 12 months post radiation treatment completion
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).
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).
Measured: Baseline
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).
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).
Measured: 12 months post radiation treatment completion
Patient-reported quality of life.
Measured: Baseline
Patient-reported quality of life.
Measured: 12 months post radiation treatment completion
Patient-reported coordination of care.
Measured: Baseline
Patient-reported coordination of care.
Measured: 12 months post radiation treatment completion
Patient-reported satisfaction with care.
Measured: Baseline
Patient-reported satisfaction with care.
Measured: 12 months post radiation treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startJun 2012
- Primary completionJul 2016
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Radiation Therapy Oncology Group
- Responsible party
- Sponsor
- Investigators
- Ronald C Chen, MD, MPH, Principal investigator, University of North Carolina at Chapel Hill - Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003417
- Sponsor's protocol ID
- LCCC 1218
- Status last verified
- Aug 2018
- First submitted
- 18 Nov 2013
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT02003417
- Acronym / sponsor ID
- LCCC 1218
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, External beam radiation treatment, Androgen deprivation therapy, Definitive treatment, Cardiovascular risk factors, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Radiation Therapy Oncology Group
- Study start
- Jun 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically-confirmed, non-metastatic prostate cancer patients who visit radiation oncology clinics at participating institutions: The University of North Carolina at Chapel Hill Cancer Hospital, Rex Cancer Center at the Raleigh and Wakefield locations, Marion J. Shepard Cancer Center, Coastal Carolina Radiation Oncology, The University of Virginia, High Point Regional UNC Health Care, and MedStar Georgetown University. Patients with planned radiation treatment and androgen deprivation therapy with curative intent (in definitive or post-prostatectomy settings) are eligible.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
12 secondary outcomes
Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.
Time frame: 3 months post radiation treatment completion
Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.
Time frame: 12 months post radiation treatment completion
Proportion of prostate cancer patients with guideline-recommended cardiovascular preventive care (glucose testing, cholesterol testing, and blood pressure measurement).
Time frame: Baseline
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
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
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
Patient-reported quality of life.
Time frame: Baseline
Patient-reported quality of life.
Time frame: 12 months post radiation treatment completion
Patient-reported coordination of care.
Time frame: Baseline
Patient-reported coordination of care.
Time frame: 12 months post radiation treatment completion
Patient-reported satisfaction with care.
Time frame: Baseline
Patient-reported satisfaction with care.
Time frame: 12 months post radiation treatment completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- UNC Lineberger Comprehensive Cancer CenterLink provided by the sponsor.
- National Cancer InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald C Chen, MD, MPH principal investigator
University of North Carolina at Chapel Hill - Department of Radiation Oncology
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by UNC Lineberger Comprehensive Cancer Center at 8 sites 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2018.