NCT00154843

Brief Summary

Primary: To determine factors that affect absorption and serum levels of lycopene after supplementation. Secondary:

  1. 1.To evaluate general safety and tolerability of oral lycopene 15 or 30 mg per day for 12 weeks.
  2. 2.To determine lycopene effects on reducing serum levels of prostate specific antigen (PSA) and on relieving lower urinary tract symptoms (LUTS) in relation to prostate hypertrophy as evaluated by the International Prostate Symptom Score (I-PSS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

January 14, 2008

Status Verified

August 1, 2006

Enrollment Period

1.3 years

First QC Date

September 8, 2005

Last Update Submit

January 8, 2008

Conditions

BPH

Keywords

LycopeneBPHPSAIPSS

Outcome Measures

Primary Outcomes (1)

  • serum lycopene levels

    two years

Secondary Outcomes (1)

  • I-PSS, peak flow rate

    two years

Study Arms (2)

A

EXPERIMENTAL

Lycopene 15 mg/day

Drug: Lycopene

B

EXPERIMENTAL

Lycopene 30 mg/day

Drug: Lycopene

Interventions

LycopeneDRUG

A: Lycopene15 mg/day ; B: Lycopene30 mg/day

AB

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male subjects aged 40 or older with no pathologically-proven prostate cancer or other cancers. Patients who have had a negative prostate biopsy are still acceptable.
  • Subjects with a PSA between 2.5 and 20.0 ng/ml.
  • Subjects understand the study procedures and agree to participate in the study by providing a written informed consent and scheduled blood or urine samples.
  • Subjects whose liver function and renal function tests are within normal range.

You may not qualify if:

  • Subjects who may have fluctuated serum PSAs, such as urinary tract infection, prostatitis, acute urinary retention, receiving radiotherapy to the pelvis, etc.
  • Subjects who have received a prostate surgery or biopsy within 6 weeks before the initiation of lycopene supplementation.
  • Subjects who may or will receive a prostate surgery or biopsy within 12 weeks of the initiation of lycopene supplementation.
  • Subjects who have known allergic reaction to carotenoids including lycopene.
  • Subjects who are participating or will participate in other clinical trials.
  • Subjects who are taking medications that may alter serum PSA levels, such as 5-alpha reductase inhibitor (eg. finasteride), sex steroids or hormonal agents (eg. luteinizing hormone releasing hormone agonists, cyproterone acetate, flutamide, bicalutamide, megesterol acetate, etc.).
  • Subjects who may require increased dosage of medications for lower urinary tract symptoms (LUTS) during the 12 weeks of protocol treatment. Subjects who have been put on medications for LUTS before entry and have a stabilized disease are still acceptable. These medications include, but note limited to, selective or non-selective alpha-blockers and anti-cholinergics.
  • Subjects who have or have had clinical gastrointestinal malabsorption regardless of the etiology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Interventions

Lycopene

Intervention Hierarchy (Ancestors)

CarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Yeong-Shiau Pu, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

March 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

January 14, 2008

Record last verified: 2006-08

Locations

TW(1)