Prostate CancerPhase 2NCT00354497
Prostate Cancer Screening and Dietary Heterocyclic Amines in African American Men
A Phase 2 study testing physiologic testing, study of socioeconomic and demographic variables and evaluation of cancer risk factors in people with Prostate Cancer, run by Lawrence Livermore National Laboratory at University of California at 2 sites in United States.
Trial summary
RATIONALE: Screening may help doctors find prostate cancer sooner, when it may be easier to treat. The amount of heterocyclic amines in the diet may affect prostate cancer screening results and the risk of prostate cancer. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- physiologic testing, study of socioeconomic and demographic variables and evaluation of cancer risk factors
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2002to not given
- Phase
- Phase 2
- 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 50 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- African American male
- No previous diagnosis of prostate cancer
- Desires prostate cancer screening as a routine preventative medical service
PATIENT CHARACTERISTICS:
- Lives in or near Oakland, California
- Speaks English
- No medical or other disability (e.g., blindness, psychological dysfunction, or amputation) that would preclude study participation
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Lawrence Livermore National Laboratory at University of California
Livermore, California, 94550
Kenneth T. Bogen, DrPH, MPH, MA, ScD, 925-422-0902, bogen@llnl.gov
- Recruiting
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609
Leslie J. Paine, 510-869-8833, painel@sutterhealth.org
About this study
Official title: Prostate Cancer Screening and Dietary HA Exposure in African-Americans: Phase II
RATIONALE: Screening may help doctors find prostate cancer sooner, when it may be easier to treat. The amount of heterocyclic amines in the diet may affect prostate cancer screening results and the risk of prostate cancer.
PURPOSE: This phase II trial is studying prostate cancer screening and dietary heterocyclic amines in African American men.
Read the detailed description
OBJECTIVES:
- Estimate dietary heterocyclic amine (HA) exposure in African American men who use HA-forming meats and cooking methods.
- Correlate dietary HA exposure with prostate-specific antigen and digital rectal exam screening results (i.e., higher HA exposure with increased abnormality in prostate cancer screening results) in these participants.
OUTLINE: This is a prospective study.
Participants complete a routine medical questionnaire and undergo a detailed dietary interview that focuses on meat consumption, cooking preferences, and other factors that may be associated with prostate cancer risk. Participants then undergo a digital rectal exam (DRE) and blood collection for prostate-specific antigen (PSA) testing (total PSA and % free PSA). Results of PSA testing and DRE, including follow-up instructions (if needed), are sent to the participant 3-4 weeks later.
Blood samples are also examined by phenotypic assays for UV-damage induced nucleotide excision-repair capacity.
PROJECTED ACCRUAL: A total of 800 participants will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- physiologic testing, study of socioeconomic and demographic variables, evaluation of cancer risk factors, mutation carrier screening, study of high risk factors
- Keywords
- prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiologic testingOther
study of socioeconomic and demographic variablesOther
evaluation of cancer risk factorsProcedure or surgery
mutation carrier screeningProcedure or surgery
study of high risk factorsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary heterocyclic amine (HA) exposure in African American men
Correlation of HA exposure with prostate cancer screening results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startMar 2002
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.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lawrence Livermore National Laboratory at University of California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Kenneth T. Bogen, DrPH, MPH, MA, ScD, Principal investigator, Lawrence Livermore National Laboratory at University of California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354497
- Sponsor's protocol ID
- CDR0000485428
- Other IDs
- LLNL-05-104
- Status last verified
- Aug 2008
- First submitted
- 19 Jul 2006
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Screening and Dietary HA Exposure in African-Americans: Phase II
- ClinicalTrials.gov ID
- NCT00354497
- Acronym / sponsor ID
- CDR0000485428
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Lawrence Livermore National Laboratory at University of CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2002
- First posted
- 20 Jul 2006 (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.
RATIONALE: Screening may help doctors find prostate cancer sooner, when it may be easier to treat. The amount of heterocyclic amines in the diet may affect prostate cancer screening results and the risk of prostate cancer.
PURPOSE: This phase II trial is studying prostate cancer screening and dietary heterocyclic amines in African American men.
Detailed description
OBJECTIVES:
- Estimate dietary heterocyclic amine (HA) exposure in African American men who use HA-forming meats and cooking methods.
- Correlate dietary HA exposure with prostate-specific antigen and digital rectal exam screening results (i.e., higher HA exposure with increased abnormality in prostate cancer screening results) in these participants.
OUTLINE: This is a prospective study.
Participants complete a routine medical questionnaire and undergo a detailed dietary interview that focuses on meat consumption, cooking preferences, and other factors that may be associated with prostate cancer risk. Participants then undergo a digital rectal exam (DRE) and blood collection for prostate-specific antigen (PSA) testing (total PSA and % free PSA). Results of PSA testing and DRE, including follow-up instructions (if needed), are sent to the participant 3-4 weeks later.
Blood samples are also examined by phenotypic assays for UV-damage induced nucleotide excision-repair capacity.
PROJECTED ACCRUAL: A total of 800 participants will be accrued for this study.
Study design
- Primary purpose
- Screening
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physiologic testing | Other | – |
| study of socioeconomic and demographic variables | Other | – |
| evaluation of cancer risk factors | Procedure or surgery | – |
| mutation carrier screening | Procedure or surgery | – |
| study of high risk factors | Procedure or surgery | – |
Primary outcome
Dietary heterocyclic amine (HA) exposure in African American men
Correlation of HA exposure with prostate cancer screening results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
Related trials for Prostate Cancer
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.
Lawrence Livermore National Laboratory at University of California
Livermore, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, United States
Kenneth T. Bogen, DrPH, MPH, MA, ScD principal investigator
Lawrence Livermore National Laboratory at University of California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing physiologic testing, study of socioeconomic and demographic variables and evaluation of cancer risk factors in people with Prostate Cancer, run by Lawrence Livermore National Laboratory at University of California at 2 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?
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: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary heterocyclic amine (HA) exposure in African American men. 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?
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 20 Sep 2013; AzTrials last refreshed its copy on 8 Nov 2026.