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Prostate CancerPhase 1NCT00416325

Lycopene in Preventing Prostate Cancer in Patients Who Are at High Risk of Developing Prostate Cancer

A Phase 1 study testing lycopene and laboratory biomarker analysis in people with Prostate Cancer, run by University of Illinois Chicago.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from forming in patients at high risk of developing prostate cancer. Read more about this study

Who is it for?
Ages 35 to 75 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
lycopene and laboratory biomarker analysis
How many people
18 participants
Where
No sites listed yet
Study dates
Start not givento Sep 2006
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 35 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Elevated prostate-specific antigen (PSA), meeting 1 of the following criteria:
  • PSA > 4.0 ng/mL for patients at any age
  • PSA > 2.0 ng/mL for patients 35 to 49 years of age
  • PSA rise (velocity) of > 0.75 ng/mL over the past year
  • Has undergone a prostate biopsy* (following findings of elevated PSA) within the past 180 days that failed to reveal prostate cancer
  • Prostate intraepithelial neoplasia allowed NOTE: *At least 4 core biopsies are considered acceptable

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 80-100%
  • Bilirubin ≤ 2.0 mg/dL
  • AST and ALT ≤ 2 times upper limit of normal
  • Creatinine ≤ 2.0 mg/dL
  • WBC ≥ 3,000/mm^3
  • Hemoglobin ≥ 11.0 g/dL
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 125,000/mm^3
  • No history of gastrointestinal malabsorption or other condition affecting drug absorption
  • No history of food allergy to tomato-based products
  • No history of any chronic medical condition that, in the judgment of the investigator, may pose threat or additional risk to the patient (including a current history of alcohol or drug abuse)
  • No active history of cancer or other illnesses that, in the opinion of the investigator, could represent a threat to patient's life, including congestive heart failure or uncontrolled hypertension

PRIOR CONCURRENT THERAPY:

  • No participation in any other experimental trial within the past 4 weeks
  • No concurrent chronic use of nonsteroidal anti-inflammatory drugs
  • No concurrent participation in another experimental trial
  • No concurrent supplements (except multivitamins), including herbal and soy products

About this study

Official title: Phase I Multiple Dose Pharmacokinetic Study of Lycopene Delivered in a Well-Defined Food-Based Lycopene Delivery System (Tomato Paste-Oil Mixture) in Patients at Increased Risk for Developing Prostate Cancer

RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from forming in patients at high risk of developing prostate cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of lycopene in preventing prostate cancer in patients who are at high risk of developing prostate cancer.

Read the detailed description

OBJECTIVES:

  • Define the toxicity and safety of lycopene administered as a food-based delivery system as a chemoprevention agent in patients who are at a high risk of developing prostate cancer.
  • Define the pharmacokinetics and tissue distribution in patients receiving this regimen.
  • Characterize surrogate endpoint biomarkers (SEBs) in the peripheral blood, buccal mucosa, and the prostate itself, which will provide evidence of biological activity relevant to a chemoprevention effect.
  • Characterize the oxidative stress state of the individual by studies of DNA oxidation in the prostate and buccal mucosa, as well as DNA oxidation and lipid peroxidation within the peripheral blood.
  • Define the effects of lycopene through a food delivery system on prostate histology (prostatic intraepithelial neoplasia), markers of cellular proliferation [PCNA], and apoptosis in the prostate.
  • Evaluate the effects of lycopene on the serum levels of total prostate-specific antigen (PSA), free PSA, and PSA density.
  • Provide the basic knowledge in reference to toxicity, pharmacokinetics, and SEBs needed to proceed to a large phase II or III lycopene study in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive oral lycopene in tomato paste and olive oil, once, twice, or three times daily for 3 months.

Cohorts of 6 patients receive escalating doses of lycopene until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients undergo buccal scrapings and blood collection periodically during study for pharmacokinetics and biomarker studies.

After completion of study treatment, patients are followed for 1 month.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

Conditions
Prostate Cancer
Being tested
lycopene, laboratory biomarker analysis
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.

  • lycopeneDietary supplement

  • laboratory biomarker analysisOther

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxicity as measured by NCI CTC v2.0

  2. Feasibility of daily consumption of prescribed volumes of the formulation

  3. Serum lycopene levels, including other carotenoids and lipid soluble vitamins, at 1 and 3 months

  4. Pharmacokinetics at 1 and 3 months

  5. Tissue distribution of lycopene (oral mucosa and prostate tissue)

  6. Modulation of surrogate endpoint biomarkers which include oxidative stress in blood, oral mucosa, and prostate tissue

  7. Modulation of serum prostate-specific antigen

  8. Cellular proliferation as measured by proliferating cell nuclear antigen (PCNA)

  9. Apoptosis as measured by Terminal deoxynucleotidyl Transferase Biotin-dUTP Nick End Labeling in prostate tissue

  10. Serum levels of insulin-like growth factor (IGF-1) and the modulation of prostate histology (prostatic intraepithelial neoplasia [PIN], when and if present)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2006 (estimated)
  2. Study completionSep 2006

Resources

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
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00416325
Sponsor's protocol ID
UIC-2000-0931
Other IDs
CDR0000467322
Status last verified
Sep 2006
First submitted
27 Dec 2006
Last updated
26 Jun 2013
Results posted
No

Publications

  • Gann PH, Deaton RJ, Rueter EE, van Breemen RB, Nonn L, Macias V, Han M, Ananthanarayanan V. A Phase II Randomized Trial of Lycopene-Rich Tomato Extract Among Men with High-Grade Prostatic Intraepithelial Neoplasia. Nutr Cancer. 2015;67(7):1104-12. doi: 10.1080/01635581.2015.1075560.

    PubMed 26422197

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing lycopene and laboratory biomarker analysis in people with Prostate Cancer, run by University of Illinois Chicago.

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: finished, as of the sponsor's last update on 26 Jun 2013. 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.

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?

Toxicity as measured by NCI CTC v2.0. The study lists 10 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 NCT00416325, which also lists 1 linked publication.

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 26 Jun 2013.

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