Prostatic Intraepithelial NeoplasiaPhase 1NCT00178113
A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia
A Phase 1 study testing - Lyc-O-Mato (dietary supplement, 30 mg lycopene/day) and - Certagen (multivitamins with minerals) in people with Prostatic Intraepithelial Neoplasia, run by University of Pittsburgh at 1 site in Trinidad and Tobago.
Trial summary
The purpose of this study is to determine whether dietary lycopene supplementation lowers serum prostate specific antigen(PSA) in men with high grade intraepithelial neoplasia (HGPIN). Read more about this study
- Who is it for?
- Ages 40 to 79 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Intraepithelial Neoplasia
- What is being tested?
- - Lyc-O-Mato (dietary supplement, 30 mg lycopene/day) and - Certagen (multivitamins with minerals)
- How many people
- 80 participants
- Where
- 1 siteTrinidad and Tobago
- Study dates
- Jul 2003to Jul 2004
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- biopsy reported high grade prostatic intraepithelial neoplasia
- and/or biopsy reported atypia
- and/or persistently elevated serum prostate specific antigen with normal biopsy
Who cannot join
- biopsy diagnosed prostate cancer
- serum prostate specific antigen > 40 ng/ml
- hospitalization in past six months
- history of allergy to tomatoes
- history of allergic dermatitis
- serious concurrent illness
- inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Trinidad and Tobago1 site
Tobago Prostate Survey Office
Scarborough, Tobago
About this study
Official title: Phase I Clinical Trial: Randomized Lycopene Supplementation in Tobago Men With High-Grade Prostatic-Intraepithelial Neoplasia
The purpose of this study is to determine whether dietary lycopene supplementation lowers serum prostate specific antigen(PSA) in men with high grade intraepithelial neoplasia (HGPIN).
Read the detailed description
Observational studies suggest higher lycopene intake or higher lycopene blood levels are associated with a lower risk for prostate cancer. Two recent trials of lycopene supplementation conducted in men with prostate cancer, during the three weeks prior to radical prostatectomy, found a reduction in serum PSA suggesting a regression of prostate cancer.
High grade intraepithelial neoplasia (HGPIN)is thought to be a precancerous lesion, and men with HGPIN have an elevated risk of prostate cancer diagnosis on subsequent biopsy. The objective of this study is to determine whether dietary lycopene supplementation lowers serum prostate specific antigen(PSA)over four months of supplementation. Serum PSA is compared in men randomized to 30 mg/day lycopene plus a standard multivitamin versus standard multivitamin alone.
- Conditions
- Prostatic Intraepithelial Neoplasia
- Being tested
- - Lyc-O-Mato (dietary supplement, 30 mg lycopene/day), - Certagen (multivitamins with minerals)
- Keywords
- Prostatic Intraepithelial Neoplasia, Prostate-Specific Antigen, lycopene
- Medical subject headings
- Prostatic Intraepithelial Neoplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
- Lyc-O-Mato (dietary supplement, 30 mg lycopene/day)Drug
- Certagen (multivitamins with minerals)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum PSA at randomization, one month, four months
Secondary outcomes (1)
Serum lycopene at randomization, one month, four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJul 2003
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Clareann H Bunker, PhD, Principal investigator, University of PittsburghLewis H Kuller, MD, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178113
- Sponsor's protocol ID
- R01CA084950-05S1
- Other IDs
- P200202-134PRC02-134
- Status last verified
- May 2015
- First submitted
- 13 Sep 2005
- Last updated
- 27 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial: Randomized Lycopene Supplementation in Tobago Men With High-Grade Prostatic-Intraepithelial Neoplasia
- ClinicalTrials.gov ID
- NCT00178113
- Acronym / sponsor ID
- R01CA084950-05S1
- Conditions
- Prostatic Intraepithelial Neoplasia
- Keywords
- Prostatic Intraepithelial Neoplasia, Prostate-Specific Antigen, lycopene
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2003
- Study completion
- Jul 2004
- First posted
- 15 Sep 2005 (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.
The purpose of this study is to determine whether dietary lycopene supplementation lowers serum prostate specific antigen(PSA) in men with high grade intraepithelial neoplasia (HGPIN).
Detailed description
Observational studies suggest higher lycopene intake or higher lycopene blood levels are associated with a lower risk for prostate cancer. Two recent trials of lycopene supplementation conducted in men with prostate cancer, during the three weeks prior to radical prostatectomy, found a reduction in serum PSA suggesting a regression of prostate cancer.
High grade intraepithelial neoplasia (HGPIN)is thought to be a precancerous lesion, and men with HGPIN have an elevated risk of prostate cancer diagnosis on subsequent biopsy. The objective of this study is to determine whether dietary lycopene supplementation lowers serum prostate specific antigen(PSA)over four months of supplementation. Serum PSA is compared in men randomized to 30 mg/day lycopene plus a standard multivitamin versus standard multivitamin alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 79 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- biopsy reported high grade prostatic intraepithelial neoplasia
- and/or biopsy reported atypia
- and/or persistently elevated serum prostate specific antigen with normal biopsy
Key exclusion criteria (7 listed)
- biopsy diagnosed prostate cancer
- serum prostate specific antigen > 40 ng/ml
- hospitalization in past six months
- history of allergy to tomatoes
- history of allergic dermatitis
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 |
|---|---|---|
| - Lyc-O-Mato (dietary supplement, 30 mg lycopene/day) | Drug | – |
| - Certagen (multivitamins with minerals) | Drug | – |
Primary outcome
Serum PSA at randomization, one month, four months
1 secondary outcome
Serum lycopene at randomization, one month, four months
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 27 May 2015.
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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.
Clareann H Bunker, PhD principal investigator
University of Pittsburgh
Lewis H Kuller, MD study director
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing - Lyc-O-Mato (dietary supplement, 30 mg lycopene/day) and - Certagen (multivitamins with minerals) in people with Prostatic Intraepithelial Neoplasia, run by University of Pittsburgh at 1 site in Trinidad and Tobago.
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 3 inclusion and 7 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 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Trinidad and Tobago. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Serum PSA at randomization, one month, four months. 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 27 May 2015.