CompletedNCT00946309PHASEUpdated Nov 15, 2016Results posted

Effects of Sulforaphane on Normal Prostate Tissue

A Phase 1/2 interventional study of High Sulforaphane Extract (Broccoli Sprout Extract) and Microcrystalline Cellulose NF (placebo) in Prostate Cancer, sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Open to male participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-11-15.

Sponsored by Fred Hutchinson Cancer Center · Phase 1/2, Interventional, and Prevention

Phase: Phase 1/2
Study type: Interventional
Enrollment: 45
Allocation: Randomized
Ages: 40 Years to 75 Years
Sex: Male

Study summary

The investigators proposed to identify the biological effects of a high-sulforaphane broccoli sprout extract in normal prostate tissue.

The investigators hypothesize that consumption of high-sulforaphane broccoli sprout extract every other day will inhibit growth of prostate cancer cells.

Conditions studied

Prostate Cancer

Browse trials for

Prostatic Neoplasms 6,367

In context

Prostatic Neoplasms

6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's enrollment of 45 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 75 Years
Sexes eligible: Male
Accepts healthy volunteers: No

Inclusion criteria

Men aged 40-75 years
Low or intermediate grade prostate cancer (as defined by Gleason sum less than or equal to 7) and clinical stage T1 or T2
Serum Prostate specific antigen less than 20 ng/ml
Have elected radical prostatectomy, Brachytherapy or active surveillance as their primary treatment

Exclusion criteria

Exclusion Criteria:

No current physician diagnosed disease (including but not limited to): kidney disease requiring dialysis, cognitive deficits, substance abuse
BMI \< 18.5 kg/m2 or > 40 kg/m2
Use of any hormonal treatments, including but not limited to testosterone
Any previous cancer diagnosis or treatment within the previous five years, excluding non-melanoma skin cancer
Inability or unwillingness to eat a diet that is free of Brassica vegetables for the duration of the study
Use of any dietary supplements other than a multivitamin (including herbal preparations)
Allergy to cruciferous vegetables or any of the specific fillers used in the placebo
Usual consumption of > 5 servings per week of Brassica vegetables

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 45 participants (actual)

Study arms

Experimental
High Sulforaphane Extract
Drug: High Sulforaphane Extract (Broccoli Sprout Extract)
Placebo comparator
Placebo
Drug: Microcrystalline Cellulose NF (placebo)

Interventions

DrugHigh Sulforaphane Extract (Broccoli Sprout Extract)
100 umol sulforaphane, every other day for 5 weeks
Also known as: Broccoli Sprout Extract
DrugMicrocrystalline Cellulose NF (placebo)
250 mg every other day for 6 weeks

What researchers measure

Primary outcomes

Gene Expression of Phase II Enzymes
Change in Phase II enzyme expression
Time frame: Baseline and 5 weeks
Lipid Oxidation
Blood F2 Isoprostane levels
Time frame: Baseline and 5 weeks
DNA Oxidation
Prostate tissue 8-hydroxy-2'-deoxyguanosine (8OHdG) levels
Time frame: Five weeks
DHT Levels
Change in serum dihydrotestosterone (DHT) levels
Time frame: Baseline and 5 weeks
Testosterone Levels
Change in testosterone (T) levels
Time frame: Baseline and 5 weeks
3-alpha-diol Gluconate Levels
Change in serum 3-alpha-diol gluconate(3α-DG) levels
Time frame: Baseline and 5 weeks

Results

Posted Nov 15, 2016

Participant flow

Recruitment occurred from July 2010 to April 2014 at the VA Puget Sound Health Care System.

Participant flow — Overall Study
Milestone	Sulforaphane	Placebo
Started	22	23
Completed	21	19
Not completed	1	4
Withdrew: Protocol violation	1	0
Withdrew: Lost to follow-up	0	1
Withdrew: Procedure cancelled/discontinued	0	3

Outcome measures

PrimaryGene Expression of Phase II Enzymes

Change in Phase II enzyme expression

Time frame:: Baseline and 5 weeks
Reported as:: Mean · -fold change in expression

Gene Expression of Phase II Enzymes
-fold change in expression	Sulforaphane	Placebo
Glutathione peroxidase 4 (GPX4) expression	-0.36 ± 2.0	0.26 ± 1.1
Glutathione S-transferase A2 (GSTa2) expression	0.15 ± 4.1	-0.59 ± 3.0
NAD(P)H:quinone oxidoreductase (NQ01) expression	-0.02 ± 1.3	0.42 ± 0.10
RODH5 F2/R2 expression	-0.10 ± 2.6	-0.02 ± 2.6
Superoxide dismutase (SOD1) expression	0.35 ± 1.1	0.5 ± 1.0

PrimaryLipid Oxidation

Blood F2 Isoprostane levels

Time frame:: Baseline and 5 weeks

No measurements were reported for this outcome.

PrimaryDNA Oxidation

Prostate tissue 8-hydroxy-2'-deoxyguanosine (8OHdG) levels

Time frame:: Five weeks

No measurements were reported for this outcome.

PrimaryDHT Levels

Change in serum dihydrotestosterone (DHT) levels

Time frame:: Baseline and 5 weeks
Reported as:: Mean · pg/mL

DHT Levels
pg/mL	Sulforaphane	Placebo
DHT Levels	2.09 ± 77.8	19.33 ± 98.0

PrimaryTestosterone Levels

Change in testosterone (T) levels

Time frame:: Baseline and 5 weeks
Reported as:: Mean · ng/dL

Testosterone Levels
ng/dL	Sulforaphane	Placebo
Testosterone Levels	-36.79 ± 79.1	5.75 ± 156.8

Primary3-alpha-diol Gluconate Levels

Change in serum 3-alpha-diol gluconate(3α-DG) levels

Time frame:: Baseline and 5 weeks
Reported as:: Mean · ng/mL

3-alpha-diol Gluconate Levels
ng/mL	Sulforaphane	Placebo
3-alpha-diol Gluconate Levels	-0.69 ± 1.6	0.39 ± 1.2

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Sulforaphane	—	0/21 (0%)	19/21 (90.5%)
Placebo	—	0/23 (0%)	18/23 (78.3%)

Most frequent other events

Showing 10 of 21

Most frequent other events
Event	Sulforaphane	Placebo
Flatulence (Grade 1)Gastrointestinal disorders	9/21	4/23
Diarrhea (Grade 1)Gastrointestinal disorders	6/21	7/23
Burping (Grade 1)Gastrointestinal disorders	4/21	6/23
Abdominal Bloating (Grade 1)Gastrointestinal disorders	5/21	3/23
Heartburn (Grade 1)Gastrointestinal disorders	5/21	3/23
Abdominal Pain (Grade 1)Gastrointestinal disorders	5/21	2/23
NauseaGastrointestinal disorders	4/21	4/23
Constipation (Grade 1)Gastrointestinal disorders	3/21	4/23
Change in Stool Consistency (Grade 1)Gastrointestinal disorders	0/21	4/23
Constipation (Grade 2)Gastrointestinal disorders	3/21	0/23

Baseline characteristics

One participant enrolled to the placebo arm was determined to be ineligible, and was withdrawn from the study Two additional participants enrolled to the placebo arm became ineligible after enrollment, and were withdrawn from the study

Age, Categorical
Age, Categorical(Participants)	Sulforaphane	Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	12	17	29
>=65 years	10	6	16

Age, Continuous
Age, Continuous(years)	Sulforaphane	Placebo	Total
Mean	62.6 ± 5.4	62.8 ± 4.3	62.7 ± 4.8

Sex: Female, Male
Sex: Female, Male(Participants)	Sulforaphane	Placebo	Total
Female	0	0	0
Male	22	23	45

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Sulforaphane	Placebo	Total
Hispanic or Latino	0	1	1
Not Hispanic or Latino	22	22	44
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Sulforaphane	Placebo	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	4	3	7
White	16	20	36
More than one race	1	0	1
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Sulforaphane	Placebo	Total
United States	22	23	45

Study locations

1 site

VA Puget Sound
Seattle, Washington 98108, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00946309
Lead sponsor: Fred Hutchinson Cancer Center
Collaborators: VA Puget Sound Health Care System, Seattle Institute for Biomedical and Clinical Research, Johns Hopkins University, University of Washington, Cedars-Sinai Medical Center
Responsible party: Daniel Lin (Principal Investigator, Fred Hutchinson Cancer Center) — Principal investigator
First posted: Jul 27, 2009
Start date: Jul 2010
Primary completion: May 2014
Completion: May 2015
Results posted: Nov 15, 2016
Last update: Nov 15, 2016

Study contacts

Daniel W Lin, MD

principal investigator · Fred Hutchinson Cancer Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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