Prostate Cancer
Conditions
Brief 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.
Interventions
DRUGHigh Sulforaphane Extract (Broccoli Sprout Extract)
100 umol sulforaphane, every other day for 5 weeks
250 mg every other day for 6 weeks
Sponsors
VA Puget Sound Health Care System
Seattle Institute for Biomedical and Clinical Research
Johns Hopkins University
University of Washington
Cedars-Sinai Medical Center
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 75 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gene Expression of Phase II Enzymes | Baseline and 5 weeks | Change in Phase II enzyme expression |
| Lipid Oxidation | Baseline and 5 weeks | Blood F2 Isoprostane levels |
| DNA Oxidation | Five weeks | Prostate tissue 8-hydroxy-2'-deoxyguanosine (8OHdG) levels |
| DHT Levels | Baseline and 5 weeks | Change in serum dihydrotestosterone (DHT) levels |
| Testosterone Levels | Baseline and 5 weeks | Change in testosterone (T) levels |
| 3-alpha-diol Gluconate Levels | Baseline and 5 weeks | Change in serum 3-alpha-diol gluconate(3α-DG) levels |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred from July 2010 to April 2014 at the VA Puget Sound Health Care System.
Pre-assignment details
There were no pre-assignment events. Group assignment occurred at the time of participant enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Sulforaphane High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks | 22 |
| Placebo Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks | 23 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Procedure cancelled/discontinued | 0 | 3 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Sulforaphane | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 6 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 17 Participants | 29 Participants |
| Age, Continuous | 62.6 years STANDARD_DEVIATION 5.4 | 62.8 years STANDARD_DEVIATION 4.3 | 62.7 years STANDARD_DEVIATION 4.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 22 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 20 Participants | 36 Participants |
| Region of Enrollment United States | 22 participants | 23 participants | 45 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 22 Participants | 23 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 21 | 18 / 23 |
| serious Total, serious adverse events | 0 / 21 | 0 / 23 |
Outcome results
Primary
3-alpha-diol Gluconate Levels
Change in serum 3-alpha-diol gluconate(3α-DG) levels
Time frame: Baseline and 5 weeks
Population: Due to budget restrictions, outcome data from only collected from the first 25 participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sulforaphane | 3-alpha-diol Gluconate Levels | -0.69 ng/mL | Standard Deviation 1.6 |
| Placebo | 3-alpha-diol Gluconate Levels | 0.39 ng/mL | Standard Deviation 1.2 |
Primary
DHT Levels
Change in serum dihydrotestosterone (DHT) levels
Time frame: Baseline and 5 weeks
Population: Due to budget restrictions, outcome data from only collected from the first 25 participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sulforaphane | DHT Levels | 2.09 pg/mL | Standard Deviation 77.8 |
| Placebo | DHT Levels | 19.33 pg/mL | Standard Deviation 98 |
Primary
DNA Oxidation
Prostate tissue 8-hydroxy-2'-deoxyguanosine (8OHdG) levels
Time frame: Five weeks
Population: Outcome data were not collected due to budget restrictions
Primary
Gene Expression of Phase II Enzymes
Change in Phase II enzyme expression
Time frame: Baseline and 5 weeks
Population: Due to budget restrictions, outcome data from only collected from the first 20 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sulforaphane | Gene Expression of Phase II Enzymes | Glutathione S-transferase A2 (GSTa2) expression | 0.15 -fold change in expression | Standard Deviation 4.1 |
| Sulforaphane | Gene Expression of Phase II Enzymes | RODH5 F2/R2 expression | -0.10 -fold change in expression | Standard Deviation 2.6 |
| Sulforaphane | Gene Expression of Phase II Enzymes | Glutathione peroxidase 4 (GPX4) expression | -0.36 -fold change in expression | Standard Deviation 2 |
| Sulforaphane | Gene Expression of Phase II Enzymes | Superoxide dismutase (SOD1) expression | 0.35 -fold change in expression | Standard Deviation 1.1 |
| Sulforaphane | Gene Expression of Phase II Enzymes | NAD(P)H:quinone oxidoreductase (NQ01) expression | -0.02 -fold change in expression | Standard Deviation 1.3 |
| Placebo | Gene Expression of Phase II Enzymes | Superoxide dismutase (SOD1) expression | 0.5 -fold change in expression | Standard Deviation 1 |
| Placebo | Gene Expression of Phase II Enzymes | Glutathione peroxidase 4 (GPX4) expression | 0.26 -fold change in expression | Standard Deviation 1.1 |
| Placebo | Gene Expression of Phase II Enzymes | Glutathione S-transferase A2 (GSTa2) expression | -0.59 -fold change in expression | Standard Deviation 3 |
| Placebo | Gene Expression of Phase II Enzymes | NAD(P)H:quinone oxidoreductase (NQ01) expression | 0.42 -fold change in expression | Standard Deviation 0.1 |
| Placebo | Gene Expression of Phase II Enzymes | RODH5 F2/R2 expression | -0.02 -fold change in expression | Standard Deviation 2.6 |
Primary
Lipid Oxidation
Blood F2 Isoprostane levels
Time frame: Baseline and 5 weeks
Population: Outcome data were not collected due to budget restrictions
Primary
Testosterone Levels
Change in testosterone (T) levels
Time frame: Baseline and 5 weeks
Population: Due to budget restrictions, outcome data from only collected from the first 25 participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sulforaphane | Testosterone Levels | -36.79 ng/dL | Standard Deviation 79.1 |
| Placebo | Testosterone Levels | 5.75 ng/dL | Standard Deviation 156.8 |