Trial Outcomes & Findings for Chemoprevention of Prostate Cancer, HDAC Inhibition and DNA Methylation (NCT NCT01265953)

Last Updated: 2019-05-01

Results Overview

Collection of blood and urine specimens occurred at pre-intervention and post-intervention. Change = post-intervention level minus pre-intervention level

Recruitment status

COMPLETED

Study phase

Target enrollment

98 participants

Primary outcome timeframe

Baseline and 4-8 weeks following intervention

Results posted on

2019-05-01

Participant Flow

Participant milestones

Participant milestones
Measure	Supplement Subjects in this group were administered with broccoli sprout extract.	Placebo Subjects in this group were administered with placebo.
Overall Study STARTED	50	48
Overall Study COMPLETED	45	45
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Supplement Subjects in this group were administered with broccoli sprout extract.	Placebo Subjects in this group were administered with placebo.
Overall Study Non compliance	5	3

Baseline Characteristics

Chemoprevention of Prostate Cancer, HDAC Inhibition and DNA Methylation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Broccoli Sprout Extract Capsules n=50 Participants Four weeks broccoli sprout extract (BSE) capsules: 200µmol of sulforaphane (SFN) daily, 2 capsules (1 capsule B.I.D.) daily	Placebo Capsules n=48 Participants Four weeks placebo capsules: 2 capsules (1 capsule B.I.D.) daily Dietary Supplement: Gelatin capsule containing microcrystalline cellulose	Total n=98 Participants Total of all reporting groups
Age, Continuous	65.7 years STANDARD_DEVIATION 5.4 • n=5 Participants	64.9 years STANDARD_DEVIATION 5.0 • n=7 Participants	65.3 years STANDARD_DEVIATION 5.2 • 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	50 Participants n=5 Participants	48 Participants n=7 Participants	98 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants	46 Participants n=7 Participants	94 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	50 Participants n=5 Participants	48 Participants n=7 Participants	98 Participants n=5 Participants
BMI	28.9 kg/m^2 STANDARD_DEVIATION 7.6 • n=5 Participants	31.1 kg/m^2 STANDARD_DEVIATION 6.4 • n=7 Participants	30.0 kg/m^2 STANDARD_DEVIATION 7.1 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 4-8 weeks following intervention

Population: Not all subjects had urine samples for analysis, therefore, the total number of subjects in this urine analysis is different from total number of enrolled subjects.

Collection of blood and urine specimens occurred at pre-intervention and post-intervention. Change = post-intervention level minus pre-intervention level

Outcome measures

Outcome measures
Measure	Supplement n=42 Participants Subjects in this group were administered with broccoli sprout extract.	Placebo n=44 Participants Subjects in this group were administered with placebo.
Change of Total Urine SFN (Sulforaphane) Metabolites	4.75 micromolar (µM) concentrations of urina Standard Error 0.64	-0.02 micromolar (µM) concentrations of urina Standard Error 0.01

PRIMARY outcome

Timeframe: Baseline and 4-8 weeks following intervention

Population: We missed blood samples from some subjects, therefore, total number of subjects analyzed for the plasma-based analysis is different from the number of total enrolled subjects.

In subjects at risk for prostate cancer, presence of SFN was analyzed in plasma. Collection of blood specimens occurred at pre-intervention and post-intervention. The Change = post-intervention level minus pre-intervention level

Outcome measures

Outcome measures
Measure	Supplement n=42 Participants Subjects in this group were administered with broccoli sprout extract.	Placebo n=44 Participants Subjects in this group were administered with placebo.
Change of Total Plasma SFN (Sulforaphane) Metabolites Level	0.12 micromolar (µM) Standard Error 0.03	-0.0003 micromolar (µM) Standard Error 0.0002

PRIMARY outcome

Timeframe: Baseline and 4-8 weeks following intervention; prostate biopsy were collected post-intervention when clinically-indicated

Population: Some subjects did not have post-intervention prostate tissue that can be used for IHC analysis, therefore, the overall number of participants analyzed for IHC analysis is different from the total enrolled subjects.

Ki67 is a biomarker of disease progression. Immunohistochemical (IHC) analysis of Ki67 was performed using research only prostate biopsy specimens collected post-intervention at the time of the clinically-indicated prostate biopsy.

Outcome measures

Outcome measures
Measure	Supplement n=41 Participants Subjects in this group were administered with broccoli sprout extract.	Placebo n=42 Participants Subjects in this group were administered with placebo.
Percentage of Ki67 Positive Cells up to 8 Weeks Post-randomization	1.8 percent positive Standard Error 0.2	1.9 percent positive Standard Error 0.3

PRIMARY outcome

Timeframe: Baseline and 4-8 weeks following intervention; prostate biopsy were collected post-intervention when clinically-indicated

Immunohistochemical (IHC) analysis of HDAC6 expression using research-only prostate biopsy tissue collected post-intervention at the time of the clinically-indicated prostate biopsy. A modified Histo-score (H-score) was calculated, which involved semiquantitative assessment of both staining intensity (graded as 1-3 with 1 representing weak staining, 2 moderate, and 3 strong) and percentage of positive cells. H-score ranged from 0 to 300 with 300 the strongest expression.

Outcome measures

Outcome measures
Measure	Supplement n=41 Participants Subjects in this group were administered with broccoli sprout extract.	Placebo n=42 Participants Subjects in this group were administered with placebo.
Expression of Histone Deacetylase 6 (HDAC6)	187 H-score Standard Error 13	183 H-score Standard Error 12.5

Adverse Events

Supplement

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Supplement n=50 participants at risk Subjects in this group were administered with broccoli sprout extract.	Placebo n=48 participants at risk Subjects in this group were administered with placebo.
Nervous system disorders Headache	2.0% 1/50 • Number of events 1	0.00% 0/48
Nervous system disorders Taste Alteration	0.00% 0/50	2.1% 1/48 • Number of events 1
Gastrointestinal disorders Bloating	2.0% 1/50 • Number of events 1	0.00% 0/48

Additional Information

Dr.Jackilen Shannon

Oregon Health & Science University

Phone: 503-418-9860

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place