Prostatic NeoplasmPCaPNCT03289130
Dietary Factors and Racial Disparities in Prostate Cancer Aggressiveness
An observational study of Prostatic Neoplasm, run by University of South Carolina.
Trial summary
The North Carolina-Louisiana Prostate Cancer Project is a population-based case-only study of over 2,000 men newly diagnosed with prostate cancer designed to address racial differences in prostate cancer aggressiveness and survival through a comprehensive evaluation of social, individual, and tumor level influences on… Read more about this study
- Who is it for?
- Ages 40 to 79 years, men only
- Conditions the study is for
- Prostatic Neoplasm
- How many people
- 2,258 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Aug 2009
- 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 40 to 79 years
- Men only
- Adult, Older adult
Study population: Residents of North Carolina and Louisiana with a first diagnosis of prostate cancer.
Who may be able to join
- first diagnosis of histologically confirmed adenocarcinoma of the prostate
- 40-79 years old at diagnosis,
- can complete the study interview in English,
- do not live in an institution (nursing home),
- are not cognitively impaired or in a severely debilitated physical state,
- are not under the influence of alcohol, severely medicated, or apparently psychotic at the time of the interview.
- must self-identify as at least part African American/Black or Caucasian American/White/European American.
Who cannot join
- -
About this study
Official title: The North Carolina-Louisiana Prostate Cancer Project, Project 3 Ancillary Study
The North Carolina-Louisiana Prostate Cancer Project is a population-based case-only study of over 2,000 men newly diagnosed with prostate cancer designed to address racial differences in prostate cancer aggressiveness and survival through a comprehensive evaluation of social, individual, and tumor level influences on prostate cancer aggressiveness. Project 3 specifically aims to examine nutritional modulation of prostate cancer aggressiveness using dietary assessment and biomarker-based data on dietary factors.
Read the detailed description
A total of 2,258 (1,130 African Americans and 1128 European Americans) men newly diagnosed with prostate cancer in North Carolina and Louisiana were enrolled into the study between 2004 and 2009. Participants signed informed consent and were interviewed by a trained nurse who collected information on demographics, occupation, family history, health status, health care, prostate cancer diagnosis and screening history, medication use, anthropometrics, lifestyle factors (e.g., physical activity, smoking), and diet and supplement use. Research subjects were asked to recall their diet in the year prior to prostate cancer diagnosis via a modified version of the National Cancer Institute Diet History Questionnaire. Vitamin and supplement use in the year prior to prostate cancer diagnosis was assessed via a validated questionnaire, and current use was assessed by bottle label inventory. Blood, urine, and adipose tissue samples were collected.
- Conditions
- Prostatic Neoplasm
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
High aggressive prostate cancer
Gleason score>=8, or PSA>20ng/ml, or Gleason score>7 and clinical stage T3-T4
Measured: Baseline (cross-sectional study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study startSep 2004
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2,258 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, University of North Carolina, Chapel Hill, Louisiana State University Health Sciences Center in New Orleans
- Responsible party
- Principal investigator, Susan Steck, University of South Carolina
- Investigators
- Susan E Steck, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289130
- Sponsor's protocol ID
- DAMD-11-1-0568
- Acronym
- PCaP
- Status last verified
- Apr 2019
- First submitted
- 18 Sep 2017
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data may be requested from PCaP through a centralized data request process.
Publications
Schroeder JC, Bensen JT, Su LJ, Mishel M, Ivanova A, Smith GJ, Godley PA, Fontham ET, Mohler JL. The North Carolina-Louisiana Prostate Cancer Project (PCaP): methods and design of a multidisciplinary population-based cohort study of racial differences in prostate cancer outcomes. Prostate. 2006 Aug 1;66(11):1162-76. doi: 10.1002/pros.20449.
PubMed 16676364Steck SE, Omofuma OO, Su LJ, Maise AA, Woloszynska-Read A, Johnson CS, Zhang H, Bensen JT, Fontham ETH, Mohler JL, Arab L. Calcium, magnesium, and whole-milk intakes and high-aggressive prostate cancer in the North Carolina-Louisiana Prostate Cancer Project (PCaP). Am J Clin Nutr. 2018 May 1;107(5):799-807. doi: 10.1093/ajcn/nqy037.
PubMed 29722851
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The North Carolina-Louisiana Prostate Cancer Project, Project 3 Ancillary Study
- ClinicalTrials.gov ID
- NCT03289130
- Acronym / sponsor ID
- PCaP / DAMD-11-1-0568
- Conditions
- Prostatic Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,258 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- United States Department of Defense, University of North Carolina, Chapel Hill, Louisiana State University Health Sciences Center in New Orleans
- Study start
- Sep 2004 (actual)
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 20 Sep 2017 (actual)
- 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.
The North Carolina-Louisiana Prostate Cancer Project is a population-based case-only study of over 2,000 men newly diagnosed with prostate cancer designed to address racial differences in prostate cancer aggressiveness and survival through a comprehensive evaluation of social, individual, and tumor level influences on prostate cancer aggressiveness. Project 3 specifically aims to examine nutritional modulation of prostate cancer aggressiveness using dietary assessment and biomarker-based data on dietary factors.
Detailed description
A total of 2,258 (1,130 African Americans and 1128 European Americans) men newly diagnosed with prostate cancer in North Carolina and Louisiana were enrolled into the study between 2004 and 2009. Participants signed informed consent and were interviewed by a trained nurse who collected information on demographics, occupation, family history, health status, health care, prostate cancer diagnosis and screening history, medication use, anthropometrics, lifestyle factors (e.g., physical activity, smoking), and diet and supplement use. Research subjects were asked to recall their diet in the year prior to prostate cancer diagnosis via a modified version of the National Cancer Institute Diet History Questionnaire. Vitamin and supplement use in the year prior to prostate cancer diagnosis was assessed via a validated questionnaire, and current use was assessed by bottle label inventory. Blood, urine, and adipose tissue samples were collected.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 79 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Residents of North Carolina and Louisiana with a first diagnosis of prostate cancer.
Key inclusion criteria (7 listed)
- first diagnosis of histologically confirmed adenocarcinoma of the prostate
- 40-79 years old at diagnosis,
- can complete the study interview in English,
- do not live in an institution (nursing home),
- are not cognitively impaired or in a severely debilitated physical state,
Key exclusion criteria (1 listed)
- -
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
High aggressive prostate cancer
Time frame: Baseline (cross-sectional study)
Gleason score>=8, or PSA>20ng/ml, or Gleason score>7 and clinical stage T3-T4
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 17 Apr 2019.
- Background: PubMed 16676364Schroeder JC, Bensen JT, Su LJ, Mishel M, Ivanova A, Smith GJ, Godley PA, Fontham ET, Mohler JL. The North Carolina-Louisiana Prostate Cancer Project (PCaP): methods and design of a multidisciplinary population-based cohort study of racial differences in prostate cancer outcomes. Prostate. 2006 Aug 1;66(11):1162-76. doi: 10.1002/pros.20449.
- Derived from this study: PubMed 29722851Steck SE, Omofuma OO, Su LJ, Maise AA, Woloszynska-Read A, Johnson CS, Zhang H, Bensen JT, Fontham ETH, Mohler JL, Arab L. Calcium, magnesium, and whole-milk intakes and high-aggressive prostate cancer in the North Carolina-Louisiana Prostate Cancer Project (PCaP). Am J Clin Nutr. 2018 May 1;107(5):799-807. doi: 10.1093/ajcn/nqy037.
- Individual participant dataSharing planned: Yes. Deidentified data may be requested from PCaP through a centralized data request process.
Related trials for Prostatic Neoplasm
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Susan E Steck principal investigator
University of South Carolina
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasm, run by University of South Carolina.
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 1 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 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
High aggressive prostate cancer (time frame: Baseline (cross-sectional study)). 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 NCT03289130, which also lists 2 linked publications.
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 17 Apr 2019.