Trial Outcomes & Findings for Lycopene in Treating Patients Undergoing Radical Prostatectomy for Prostate Cancer (NCT NCT00450749)

Results Overview

Total tissue lycopene concentrations in radical prostatectomy specimens in participants receiving 6 weeks (± 1 week) of preoperative supplementation with 60 mg/day lycopene, 30 mg/day lycopene, or placebo. Concentration of lycopene in prostatic surgical tissue calculated using the high-performance liquid chromatography (HPLC) method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

At 4-7 weeks

Results posted on

2019-12-18

Participant Flow

Recruitment Period: April 11, 2008 to April 15, 2009. All recruitment was done in a medical clinic setting, and all participants enrolled at Memorial Sloan-Kettering Cancer Center.

There were eleven participants registered, one participant was excluded from the trial before assignment to groups making only ten randomized.

Participant milestones

Participant milestones
Measure	Arm I Placebo Placebo once daily for 4-7 weeks.	Arm II Low Dose Lycopene 30 mg/day oral Lycopene for 4-7 weeks.	Arm III High-Dose Lycopene 60 mg/day oral Lycopene for 4-7 weeks.
Overall Study STARTED	3	3	4
Overall Study COMPLETED	3	2	2
Overall Study NOT COMPLETED	0	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I Placebo Placebo once daily for 4-7 weeks.	Arm II Low Dose Lycopene 30 mg/day oral Lycopene for 4-7 weeks.	Arm III High-Dose Lycopene 60 mg/day oral Lycopene for 4-7 weeks.
Overall Study Withdrawal by Subject	0	0	2
Overall Study Noncompliant	0	1	0

Baseline Characteristics

Lycopene in Treating Patients Undergoing Radical Prostatectomy for Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I Placebo n=3 Participants Placebo once daily for 4-7 weeks.	Arm II Low Dose Lycopene n=3 Participants 30 mg/day oral Lycopene for 4-7 weeks.	Arm III High-Dose Lycopene n=4 Participants 60 mg/day oral Lycopene for 4-7 weeks.	Total n=10 Participants Total of all reporting groups
Age, Continuous	71 years n=5 Participants	56 years n=7 Participants	66 years n=5 Participants	66.5 years n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	10 participants n=4 Participants

PRIMARY outcome

Timeframe: At 4-7 weeks

Population: Tissue samples collected from five participants for measurement of lycopene levels, representing only 50% (5 of 10) of the participants' enrolled on-trial.

Total tissue lycopene concentrations in radical prostatectomy specimens in participants receiving 6 weeks (± 1 week) of preoperative supplementation with 60 mg/day lycopene, 30 mg/day lycopene, or placebo. Concentration of lycopene in prostatic surgical tissue calculated using the high-performance liquid chromatography (HPLC) method.

Outcome measures

Outcome measures
Measure	Arm I Placebo n=2 Participants Placebo once daily for 4-7 weeks.	Arm II Low Dose Lycopene n=2 Participants 30 mg/day oral Lycopene for 4-7 weeks.	Arm III High-Dose Lycopene n=2 Participants 60 mg/day oral Lycopene for 4-7 weeks.
Concentration of Lycopene in Prostatic Surgical Tissue Sample 1	0.663 ug/dL	0.378 ug/dL	0.723 ug/dL
Concentration of Lycopene in Prostatic Surgical Tissue Sample 2	0.165 ug/dL	0.749 ug/dL	NA ug/dL A second tissue sample was not collected.

PRIMARY outcome

Timeframe: Baseline and weeks 4 and 7

Population: 10 participants were analyzed at Baseline versus 8 at Week 4 and versus 5 at Week 7 due to drop out rate.

Serum levels (ug/dL) of total lycopene at baseline and during treatment by group were measured.