Trial Outcomes & Findings for The Effects of Lycopene on High Risk Prostatic Tissue (NCT NCT01443026)

NCT ID: NCT01443026

Last Updated: 2019-11-19

Results Overview

We will use conventional immunohistochemistry and computer-based image analysis to test the hypothesis that the lycopene supplements alter the expression of proteins marking the status of proliferation, differentiation, cell regulation and apoptosis in high-risk tissue.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 66 participants
• Primary outcome timeframe: baseline and 6 months
• Results posted on: 2019-11-19

Participant Flow

Participant milestones

Measure	Lycopene Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months) Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)	Placebo Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months) Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)
Overall Study STARTED	29	37
Overall Study COMPLETED	26	32
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Measure	Lycopene Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months) Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)	Placebo Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months) Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)
Overall Study Physician Decision	1	0
Overall Study Death	0	1
Overall Study Withdrawal by Subject	0	3
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

The Effects of Lycopene on High Risk Prostatic Tissue

Baseline characteristics by cohort

Measure	Lycopene n=26 Participants Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)	Placebo n=32 Participants Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)	Total n=58 Participants Total of all reporting groups
Age, Continuous	62.9 years STANDARD_DEVIATION 8.3 • n=5 Participants	67.1 years STANDARD_DEVIATION 8.1 • n=7 Participants	65.2 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	32 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	23 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	32 participants n=7 Participants	58 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

We will use conventional immunohistochemistry and computer-based image analysis to test the hypothesis that the lycopene supplements alter the expression of proteins marking the status of proliferation, differentiation, cell regulation and apoptosis in high-risk tissue.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: baseline and 6 months

Change in serum lycopene, umol/L

Outcome measures

Measure	Lycopene n=26 Participants Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)	Placebo n=32 Participants Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
Changes in Serum Biomarkers	.55 umol/L Interval -0.7 to 1.6	-0.29 umol/L Interval -1.1 to 0.6

SECONDARY outcome

Timeframe: baseline and 6 months

We will use a computerized image analysis system designed for the chemoprevention setting to test the hypothesis that the antioxidants cause a favorable change in a nuclear morphometry index based on nuclear size, shape and chromatin texture.

Outcome measures

Outcome data not reported

Adverse Events

Lycopene

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lycopene n=26 participants at risk Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)	Placebo n=32 participants at risk Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
Cardiac disorders death	0.00% 0/26	3.1% 1/32 • Number of events 1

Other adverse events

Measure	Lycopene n=26 participants at risk Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)	Placebo n=32 participants at risk Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
Renal and urinary disorders increased urinary frequency	0.00% 0/26	3.1% 1/32 • Number of events 1
Gastrointestinal disorders constipation	0.00% 0/26	3.1% 1/32 • Number of events 1

Additional Information

Dr. Peter Gann

University of Illinois at Chicago

Phone: 312-355-3723

Email: pgann@uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place