Intraepithelial Prostatic NeoplasiaPhase 2NCT01443026
The Effects of Lycopene on High Risk Prostatic Tissue
A Phase 2 study testing Lycopene 30mg in people with Intraepithelial Prostatic Neoplasia and Prostatic Neoplasms, run by University of Illinois Chicago at 2 sites in United States.
Trial summary
The purpose of this research study is to compare the effects of a lycopene supplement made from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal cells in the prostate, but have not yet had cancer detected. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Intraepithelial Prostatic Neoplasia, Prostatic Neoplasms
- What is being tested?
- Lycopene 30mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2006to Apr 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- Have a history of prostate biopsy indicating HGPIN without cancer within 2 years prior to registration. At least 4 weeks must have elapsed between the last biopsy and the biopsy used for baseline data.
- Have an AUA symptom score <=25 at time of registration.
- Refrain from taking lycopene, selenium, vitamin E, or other antioxidant supplements within 1 month of randomization. Participants must agree to refrain from taking non-study dietary supplements while on study
- Refrain from taking exogenous hormones, drugs affecting hormone metabolism, or specified non-prescription substances (e.g. saw palmetto, PC-Spes) taken to affect the prostate within 1 month of registration. Patients must also agree to refrain from taking the non-prescription substances while on study
- Be willing to limit intake of lycopene-containing foods while on study
Show all 10Show fewer
- Have no prior cancer (except basal cell or squamous cell skin cancer) or complete remission for at least 5 years
- Be ambulatory, capable of self-care and able to carry out light or sedentary work
- Have a dietary fat intake of 23-48% of calories
- Participant's physician recommends repeat biopsy 4-6 months after randomization
Who cannot join
- No repeat biopsy planned
- Not willing to change diet
- Have a diagnosis of prostate cancer
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Jesse Brown VA Medical Center
Chicago, Illinois, 60612
About this study
Official title: R01 CA90759: The Effects of Lycopene on High Risk Prostatic Tissue
The purpose of this research study is to compare the effects of a lycopene supplement made from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal cells in the prostate, but have not yet had cancer detected. This study will allow us to see if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and in chemicals measured in the blood that go along with a higher risk of developing cancer.
- Being tested
- Lycopene 30mg, Placebo
- Keywords
- Intraepithelial Prostatic Neoplasia, Prostatic neoplasms, Male urogenital disease, Prostate
- Medical subject headings
- Prostatic Intraepithelial Neoplasia, Prostatic Neoplasms, Male Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lycopene 30mgDrug
Also called Lyco-Mato
Lycopene 30 mg.
PlaceboDrug
Also called Sugar Pill
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Lycopene | Experimental | Lycopene 30 mg/day Receives: Drug: Lycopene 30mg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Biomarkers
We will use conventional immunohistochemistry and computer-based image analysis to test the hypothesis that the lycopene supplements alter the expression of proteins marking the status of proliferation, differentiation, cell regulation and apoptosis in high-risk tissue.
Measured: baseline and 6 months
Changes in Serum Biomarkers
Change in serum lycopene, umol/L
Measured: baseline and 6 months
Secondary outcomes (1)
Changes in Nuclear Morphometry
We will use a computerized image analysis system designed for the chemoprevention setting to test the hypothesis that the antioxidants cause a favorable change in a nuclear morphometry index based on nuclear size, shape and chromatin texture.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startFeb 2006
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Intraepithelial Prostatic NeoplasiaStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Peter Gann, University of Illinois Chicago
- Investigators
- Peter H Gann, MD, ScD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443026
- Sponsor's protocol ID
- 2005-0828
- Other IDs
- R01CA090759
- Status last verified
- Nov 2019
- First submitted
- 27 Sep 2011
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Clinton SK, Emenhiser C, Schwartz SJ, Bostwick DG, Williams AW, Moore BJ, Erdman JW Jr. cis-trans lycopene isomers, carotenoids, and retinol in the human prostate. Cancer Epidemiol Biomarkers Prev. 1996 Oct;5(10):823-33.
PubMed 8896894Pastori M, Pfander H, Boscoboinik D, Azzi A. Lycopene in association with alpha-tocopherol inhibits at physiological concentrations proliferation of prostate carcinoma cells. Biochem Biophys Res Commun. 1998 Sep 29;250(3):582-5. doi: 10.1006/bbrc.1998.9351.
PubMed 9784387Giovannucci E. Tomatoes, tomato-based products, lycopene, and cancer: review of the epidemiologic literature. J Natl Cancer Inst. 1999 Feb 17;91(4):317-31. doi: 10.1093/jnci/91.4.317.
PubMed 10050865Jain MG, Hislop GT, Howe GR, Ghadirian P. Plant foods, antioxidants, and prostate cancer risk: findings from case-control studies in Canada. Nutr Cancer. 1999;34(2):173-84. doi: 10.1207/S15327914NC3402_8.
PubMed 10578485Giovannucci E, Ascherio A, Rimm EB, Stampfer MJ, Colditz GA, Willett WC. Intake of carotenoids and retinol in relation to risk of prostate cancer. J Natl Cancer Inst. 1995 Dec 6;87(23):1767-76. doi: 10.1093/jnci/87.23.1767.
PubMed 7473833Bostwick DG, Shan A, Qian J, Darson M, Maihle NJ, Jenkins RB, Cheng L. Independent origin of multiple foci of prostatic intraepithelial neoplasia: comparison with matched foci of prostate carcinoma. Cancer. 1998 Nov 1;83(9):1995-2002. doi: 10.1002/(sici)1097-0142(19981101)83:93.0.co;2-2.
PubMed 9806659Kley HK. [Therapy of Cushing's syndrome. Critical evaluation of therapeutic measures]. Hippokrates. 1978 Feb;49(1):97-100. No abstract available. German.
PubMed 632120
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- R01 CA90759: The Effects of Lycopene on High Risk Prostatic Tissue
- ClinicalTrials.gov ID
- NCT01443026
- Acronym / sponsor ID
- 2005-0828
- Keywords
- Intraepithelial Prostatic Neoplasia, Prostatic neoplasms, Male urogenital disease, Prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 29 Sep 2011 (estimated)
- Results
- Posted 4 Jun 2015
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 research study is to compare the effects of a lycopene supplement made from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal cells in the prostate, but have not yet had cancer detected. This study will allow us to see if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and in chemicals measured in the blood that go along with a higher risk of developing cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lycopene | Experimental | Drug: Lycopene 30mgLycopene 30 mg/day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male
- Have a history of prostate biopsy indicating HGPIN without cancer within 2 years prior to registration. At least 4 weeks must have elapsed between the last biopsy and the biopsy used for baseline data.
- Have an AUA symptom score <=25 at time of registration.
- Refrain from taking lycopene, selenium, vitamin E, or other antioxidant supplements within 1 month of randomization. Participants must agree to refrain from taking non-study dietary supplements while on study
- Refrain from taking exogenous hormones, drugs affecting hormone metabolism, or specified non-prescription substances (e.g. saw palmetto, PC-Spes) taken to affect the prostate within 1 month of registration. Patients must also agree to refrain from taking the non-prescription substances while on study
Key exclusion criteria (3 listed)
- No repeat biopsy planned
- Not willing to change diet
- Have a diagnosis of prostate cancer
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 |
|---|---|---|
| Lycopene 30mgAlso: Lyco-MatoLycopene 30 mg. | Drug | Lycopene |
| PlaceboAlso: Sugar PillPlacebo | Drug | Placebo |
Primary outcome
Tissue Biomarkers
Time frame: baseline and 6 months
We will use conventional immunohistochemistry and computer-based image analysis to test the hypothesis that the lycopene supplements alter the expression of proteins marking the status of proliferation, differentiation, cell regulation and apoptosis in high-risk tissue.
Changes in Serum Biomarkers
Time frame: baseline and 6 months
Change in serum lycopene, umol/L
1 secondary outcome
Changes in Nuclear Morphometry
Time frame: baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8896894Clinton SK, Emenhiser C, Schwartz SJ, Bostwick DG, Williams AW, Moore BJ, Erdman JW Jr. cis-trans lycopene isomers, carotenoids, and retinol in the human prostate. Cancer Epidemiol Biomarkers Prev. 1996 Oct;5(10):823-33.
- Background: PubMed 9784387Pastori M, Pfander H, Boscoboinik D, Azzi A. Lycopene in association with alpha-tocopherol inhibits at physiological concentrations proliferation of prostate carcinoma cells. Biochem Biophys Res Commun. 1998 Sep 29;250(3):582-5. doi: 10.1006/bbrc.1998.9351.
- Background: PubMed 10050865Giovannucci E. Tomatoes, tomato-based products, lycopene, and cancer: review of the epidemiologic literature. J Natl Cancer Inst. 1999 Feb 17;91(4):317-31. doi: 10.1093/jnci/91.4.317.
- Background: PubMed 10578485Jain MG, Hislop GT, Howe GR, Ghadirian P. Plant foods, antioxidants, and prostate cancer risk: findings from case-control studies in Canada. Nutr Cancer. 1999;34(2):173-84. doi: 10.1207/S15327914NC3402_8.
- Background: PubMed 7473833Giovannucci E, Ascherio A, Rimm EB, Stampfer MJ, Colditz GA, Willett WC. Intake of carotenoids and retinol in relation to risk of prostate cancer. J Natl Cancer Inst. 1995 Dec 6;87(23):1767-76. doi: 10.1093/jnci/87.23.1767.
- Background: PubMed 9806659Bostwick DG, Shan A, Qian J, Darson M, Maihle NJ, Jenkins RB, Cheng L. Independent origin of multiple foci of prostatic intraepithelial neoplasia: comparison with matched foci of prostate carcinoma. Cancer. 1998 Nov 1;83(9):1995-2002. doi: 10.1002/(sici)1097-0142(19981101)83:93.0.co;2-2.
- Background: PubMed 632120Kley HK. [Therapy of Cushing's syndrome. Critical evaluation of therapeutic measures]. Hippokrates. 1978 Feb;49(1):97-100. No abstract available. German.
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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.
Peter H Gann, MD, ScD principal investigator
University of Illinois Chicago
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 Lycopene 30mg in people with Intraepithelial Prostatic Neoplasia and Prostatic Neoplasms, run by University of Illinois Chicago 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?
The sponsor lists 10 inclusion and 3 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 19 Nov 2019. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 4 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tissue Biomarkers (time frame: baseline and 6 months). 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?
On the ClinicalTrials.gov record for NCT01443026, which also lists 7 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 19 Nov 2019.