Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lycopene | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Toxicity by blood chemistries and patient histories at 4 weeks after treatment
- measure
- Pharmacokinetics by blood lycopene concentrations at 4 weeks after treatment
Secondary outcomes (1)
- measure
- Define dose range by blood lycopene concentrations at 4 weeks after treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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 drugsReferences
Publications (0)
Data not yet available