A Phase 1 interventional study of lycopene in Prostate Cancer, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-26.
Sponsored by University of Illinois at Chicago · Phase 1, Interventional, and Prevention
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.
OBJECTIVES:
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
Browse Prostatic Neoplasms studies →University of Illinois at Chicago is the lead sponsor of 523 studies on the registry; 132 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Healthy participants in good medical condition
Non-smoker
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Toxicity by blood chemistries and patient histories at 4 weeks after treatment
Pharmacokinetics by blood lycopene concentrations at 4 weeks after treatment
Define dose range by blood lycopene concentrations at 4 weeks after treatment
The record gives a start of Aug 2004 and a completion of Feb 2006. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lycopene
University of Illinois at Chicago →