Lycopene in Preventing Prostate Cancer in Healthy Participants

Phase I Single Dose Pharmacokinetic Study of the Dietary Supplement Lycopene Delivered in Capsule Form to Healthy Male Volunteers Between 18 and 45 Years of Age

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00093561

Enrollment

Unknown

Registered

2004-10-08

Start date

2004-08-31

Completion date

2006-02-28

Last updated

2013-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer

Brief summary

RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. The dietary supplement lycopene may prevent the development of prostate cancer. PURPOSE: This phase I trial is studying the side effects and best dose of lycopene in preventing prostate cancer in healthy participants.

Detailed description

OBJECTIVES: * Determine the toxicity and safety of lycopene supplementation as chemoprevention for prostate cancer in healthy participants. * Determine the pharmacokinetics of this agent in these participants. * Determine the dose range of this agent in these participants. OUTLINE: This is a dose-escalation study. Participants ingest a single-dose of oral lycopene over a maximum of 15 minutes on day 1. Cohorts of 5 participants 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 5 participants experience dose-limiting toxicity. Participants are evaluated periodically for 28 days. PROJECTED ACCRUAL: A total of 25 participants will be accrued for this study.

Interventions

DIETARY_SUPPLEMENTlycopene

Study design

Primary purpose

PREVENTION

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

DISEASE CHARACTERISTICS: * Healthy participants in good medical condition * No chronic medical conditions * No regular use of prescription medications * No evidence of psychiatric disorder * Non-smoker * Former smokers allowed provided they have not smoked within the past 3 months * No history of alcohol abuse * Serum lycopene concentration \< 700 nM PATIENT CHARACTERISTICS: Age * 18 to 45 Performance status * Karnofsky 100% Life expectancy * Not specified Hematopoietic * Hemoglobin ≥ 13.0 g/dL * WBC ≥ 4,000/mm\^3 * Platelet count 150,000-400,000/mm\^3 Hepatic * AST and ALT ≤ 75 U/L * Bilirubin ≤ 2.0 mg/dL * No liver disease Renal * Creatinine ≤ 1.5 mg/dL * No renal disease Cardiovascular * No cardiovascular disease * No abnormal EKG Other * Within 15% of ideal body weight * No history of gastrointestinal malabsorption or other condition that would preclude drug absorption * No alcohol consumption within the past 72 hours * No allergy to tomato-based products * No history of cancer * No diabetes mellitus * No other illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * At least 4 weeks since prior experimental drugs * More than 14 days since prior prescription drugs * No concurrent participation in another experimental trial * No concurrent prescription drugs

Design outcomes

Primary

Measure	Time frame
Toxicity by blood chemistries and patient histories at 4 weeks after treatment	—
Pharmacokinetics by blood lycopene concentrations at 4 weeks after treatment	—

Secondary

Measure	Time frame
Define dose range by blood lycopene concentrations at 4 weeks after treatment	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026