Prostate Cancer Clinical Trial
Lycopene in Preventing Prostate Cancer in Healthy Participants
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.
Full 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.
Eligibility 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Chicago Illinois, 60612, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.