Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Herbal and Botanical

All Drugs and Chemicals

Tomato

Tomato Product

Control

Eunyoung Park, M.S.

The purposes of this study are to explore the dynamics of adherence, using a simple whole food intervention strategy, both prior to and during the intervention period and to identify nutrient shifts in self-selected diets and to determine health risks (blood pressure, hyperlipidemia, and body weight) that may have resulted from increased tomato product consumption.

African-American (AA) men suffer the greatest proportion of health disparities of any studied category and adherence to advice among this group has been vastly understudied.

Although there are several ongoing trials for behavioral change, either of diet or lifestyle, enrollment rates of AA men (\< 25%) often provide insufficient numbers to evaluate adherence issues separately.

Tomatoes, more than lycopene alone, may have beneficial effects on prostate health, including BPH and prostate cancer. Efficacy trials would require long-term adherence to high levels of tomato product (TP) consumption.

Adherence Dynamics for Whole Food Interventions in African-American Men

The intervention group: aimed to achieve the goal of more than five servings of TP/week while control group aimed to eat vegetable instead of tomatoes.

Using 24-hr recall weekly, consumption of tomato product was measured by serving size.

Using 24-hr diet recall, types of tomato products were counted.

University of Illinois at Chicago

Student

Tomato Product: Motivational Telephone Counseling weekly

No Motivation telephone Counseling

Control: No Motivational telephone Counseling

Total

Age, Continuous

Sex: Female, Male

The number of phone calls and collected diet recalls between groups was different because of concern that the control group would increase their tomato product intake.

Dr. Phyllis E. Bowen

Tomato Product Intake Between Different Groups

Diet Adherence to Tomato Product Consumption Between Different Groups

Consumption of Tomato Products Between Different Groups

Motivational telephone counseling weekly

Tomato Product: Motivational Telephone Counseling weekly

Differences in Dietary Lycopene Intake Between Different Groups

Plasma Lycopene Concentration Between Different Groups

Overall Study

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Dutasteride

5-alpha Reductase Inhibitors

Enzyme Inhibitors

Hormones

Hormone Antagonists

Eligible subjects will complete a 4-week placebo run-in followed by randomization to matched placebo in a 1:1 ratio.

Eligible subjects will complete a 4-week placebo run-in followed by randomization to 0.5mg dutasteride in a 1:1 ratio. Randomization will be stratified by center.

After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily dosing of 0.5mg of dutasteride orally for up to 4 years.

After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily orally for up to 4 years.

Placebo

GSK Clinical Trials

This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.

"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (CPL, which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (high-grade prostatic intraepithelial neoplasia\[HGPIN\] or typical small acinar proliferation \[ASAP\]) and prostate surgeries were reviewed by the lead pathologist.

Study biopsies (biop.) consisted of 10 biop. samples (cores) in a pre-defined pattern and were read at the central pathology laboratory. Biop. cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk sets at Years 1-2 and Years 3-4 included those with a positive biop. at Years 1-2 or a biop. after Months 18-24, and those with a positive biop. at Years 3-4 or a biop. after Month 42, respectively. Overall included participants with a positive biop. or biop. after Month 42.

Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk set at Years 1-2, Years 3-4, and Overall (Years 1-4) were those who had a biopsy during the specified time period.

Gleason score was determined by examining prostate biopsies and surgical samples. The Gleason scoring system sums the two most common Gleason grade patterns in order to predict the likelihood of a participant doing well or badly with their cancer. Gleason grades range from 1 (normal) to 5 (advanced cancer). The lowest Gleason score is 2 (1+1), and the highest Gleason score is 10 (5+5). A Gleason score of 2-6 is a low-grade cancer; a Gleason score of 7-10 is high-grade cancer. The most severe high-grade cancers are the subset of Gleason scores 8-10.

The occurrence and quantity of high-grade prostatic intraepithelial neoplasia (HGPIN) and atypical small acinar proliferation (ASAP) at biopsy were measured. HGPIN and ASAP are considered precancerous conditions. A participant diagnosed with prostate cancer only (i.e., no HGPIN or ASAP) was counted in both the first category ("HGPIN or prostate cancer diagnosis") and again in the last category ("HGPIN, ASAP, or prostate cancer diagnosis").

The amount of prostate biopsy tissue with HGPIN was measured.

The average amount of cancer seen by the pathologist in the prostate tissue samples taken during the biopsy was measured. A core is a prostate biopsy sample.

The average number of prostate biopsy samples (cores) determined to be cancerous by the pathologist was measured. Normally, 10 cores were taken per biopsy for each participant.

The treatment alteration score is a measure of the cellular changes due to treatment (effect of male hormone withdrawal) on the nucleus and cytoplasm of the prostate cancer cell. The treatment alteration score is the sum of two scores (the nuclear alteration score and the cytoplasmic architectural score), each ranging from 0 to 3, with 0 indicating no change and 3 indicating severe changes.

The number of participants who received treatment for prostate cancer was measured. Prostate cancer interventions included surgical interventions (e.g., prostatectomy, adenomectomy, transurethral resection) and non-surgical interventions (e.g., chemotherapy, hormone therapy, radiation therapy).

The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.

Prostate volume was measured by transrectal ultrasound (TRUS) when biopsies were performed at Year 2 and Year 4. The investigator calculated the prostate volume using three prostate measurements (anteroposterior, cephalocaudal, and transverse diameters). Estimates are based on the adjusted means from the general linear model: log(Post-Baseline/Baseline value) = treatment and cluster and log (baseline value).

Maximum urinary flow was measured at selected sites using a Dantec Uroflow meter with a Thompson filter. Change from baseline was calculated as Month 12, 24, 36, and 48 values minus the baseline value. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline Qmax and treatment. This measurement was performed at selected centers.

Medication taken during the study, including alpha blockers, was recorded at each 6-month study visit and during phone calls that occurred 3 months after each visit.

A participant was considered to have AUR when he reported being unable to urinate and required catherization. Participants were asked to report any events of AUR during the study.

A participant was considered to have a UTI if the investigator noted that the participant had UTI symptoms and had been prescribed antibiotics. Participants were asked to report any events of UTI during the study.

Participants reported events of macroscopic hematuria (visible blood in the urine) throughout the study.

Participants reported events of macroscopic hematospermia (visible blood in semen) throughout the study.

Overall survival is assessed as the number of deaths reported throughout the study.

The BII is a 4-item questionnaire that rates the level of BPH-related physical discomfort, worry, and interference with normal activities the participant has experienced. The total BII score ranges from 1 (no impact on symptoms) to 13 (major impact on symptoms). Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model:change from baseline = baseline value and cluster and treatment.

The MOS Sleep-6S is a 6-item questionnaire measuring quality of sleep. Scores range from 1 (all of the time) to 6 (none of the time) and are converted to a 1-100 scale and then averaged; a higher score indicates greater negative impact, which indicates more sleep disturbance. Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from baseline=baseline value and cluster and treatment.

The NIH CSPI is a 9-item questionnaire that measures chronic prostatitis symptoms. The total score ranges from 0 to 43. A higher score indicates greater negative impact of prostatitis. Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from Baseline = Baseline Value and Cluster and Treatment.

The QOL Q8 is the last question of the IPSS Questionnaire. It is a question about the participant's quality of life as it relates to prostate symptoms. Responses range from 0 (most positive) to 6 (most negative). A higher score indicates worse quality of life. Participants completed the questionnaire at Screening, Baseline, and at each 6-month visit. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.

The PASSFI is a 3-item questionnaire that measures sexual function. Responses range from 0 (big problem) to 4 (no problem), with a total score of 12. A higher score indicates fewer problems with sexual functioning. Participants completed the questionnaire at Baseline and then yearly . Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.

Number of participants whose DHT, the active form of the male sex hormone testosterone, was less than 0.555 nanomoles/liter and below the level of detection at Month 48 was measured. It was measured by taking blood samples at screening and yearly thereafter.

Testosterone, a male sex hormone, was measured by taking blood samples at screening and yearly thereafter.

GlaxoSmithKline

Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.

Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.

Dutasteride 0.5 mg

White

Black

Asian

American Hispanic

Other

Missing

Race/Ethnicity, Customized

GSK Response Center

Years 1- 2, n=4073, 4049

Years 3- 4, n=2815, 2844

Overall, n=4073, 4049

Efficacy Population: all randomized participants with a negative entry biopsy, as determined by the CPL, who received at least 1 dose of study drug. The crude rate approach included all participants at risk at the beginning of each time period .

Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach)

Years 1-2, n=3319, 3209

Years 3-4, n=2325, 2434

Overall, n=2903, 2869

Efficacy Population, modified crude rate: participants who either were diagnosed with prostate cancer during the study or had an end of time period biopsy. N for each time period is the number who either had at least 1 biopsy in the final 6 months of the time period or had a positive biopsy anytime during the time period.

Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach)

Years 1-2, n=3364, 3244

Years 3- 4, n=2359, 2451

Overall, n=3424, 3305

Efficacy Population, restricted crude rate: the number of prostate cancer events is based on the the number of participants who had at least one biopsy during the time period. Ns at Years 1-2 and Years 3-4 are the number who had a biopsy in those time periods; the overall n is the number of participants who had 1 or more biopsy during Years 1-4.

Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach)

Between 2 and 6

Between 7 and 10

Between 8 and 10

Biopsied Population: all randomized participants with a negative entry biopsy who received at least 1 dose of study treatment and who had at least 1 biopsy reviewed by the central pathology lab. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.

Number of Participants With the Indicated Gleason Score at Diagnosis

HGPIN or prostate cancer diagnosis

HGPIN and no prostate cancer

HGPIN and no ASAP and no prostate cancer

HGPIN or ASAP

HGPIN or ASAP and no prostate cancer

HGPIN, ASAP, or prostate cancer diagnosis

Biopsied Population: the number analyzed is the total number in the population

Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy

Biopsied Population. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.

Volume of HGPIN at Biopsy

Prostate Cancer Population: all participants in the Efficacy Population who received a post-baseline diagnosis of prostate cancer by the central pathology laboratory. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.

Percentage of Core Involved at Diagnosis

Prostate Cancer Population. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.

Number of Cancer-positive Cores

Nuclear, n=3357, 3256

Architectural, n=3357, 3258

Total, n=3357, 3256

Treatment Alteration Score

Any intervention

Any surgical intervention

Any non-surgical intervention

Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment

Efficacy Population, last observation carried forward (LOCF). In the LOCF approach, missing values at post-baseline assessments are replaced with the participant's previous non-missing post-baseline assessment. The number analyzed is smaller than the total number in the population due to missing values.

Adjusted Mean Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 48

Month 24, n=3192, 3116

Month 48, n=3289, 3194

Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.

Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48

Month 12, n=1178, 1168

Month 24, n=1337, 1295

Month 36, n=1375, 1334

Month 48, n=1390, 1359

Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48

Years 1-2

Overall

Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms

Number of Participants With at Least One Event of Acute Urinary Retention (AUR)

Years 1-2, n=4073, 4049

Years 3-4, n=3363, 3318

Number of Participants With at Least One Urinary Tract Infection (UTI)

Number of Participants With Post-biopsy Macroscopic Hematuria

Number of Participants With Post-biopsy Macroscopic Hematospermia

Overall Survival

Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.

Adjusted Mean Change From Baseline in the Benign Prostatic Hypertrophy (BPH) Impact Index (BII) at Month 48

Adjusted Mean Change From Baseline in The Medical Outcomes Study Sleep Problems Index 6-item Standard Version (MOS Sleep-6S) at Month 48

Adjusted Mean Change From Baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH CPSI) at Month 48

Adjusted Mean Change From Baseline in Quality of Life Question 8 (QOL Q8) at Month 48

Adjusted Mean Change From Baseline in the Problem Assessment Scale of the Sexual Function Index (PASSFI) at Month 48

<0.555 nanomoles/Liter

<level of detection

Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48

Mean Change From Baseline in Testosterone at Month 48

Antineoplastic Agents

Other Dietary Supplements

Sulforaphane

Volunteers will be required to consume one portion of broccoli soup per week as part of their normal diet for one year.

Standard broccoli soup

Volunteers will be required to consume one portion per week of a soup containing glucoraphanin-enriched broccoli (Beneforte®) as part of their normal diet for one year.

Beneforte broccoli soup

Volunteers will be in which they will be required to consume one portion per week of a soup containing an other variety of glucoraphanin-enriched broccoli (Beneforte extra) as part of their normal diet for one year.

Beneforte extra broccoli soup

Richard Mithen, PhD

The biology of prostate cancer is associated with changes in genes and metabolites within prostate tissue. There is robust evidence to suggest that a diet rich in broccoli can prevent or retard the development of prostate cancer by influencing these changes. This is likely to be due to a natural chemical that is obtained in these vegetables known as sulforaphane.

In this study, we are seeking to provide further evidence that a diet rich in broccoli may prevent prostate cancer from developing, and to understand how this may happen. We propose to undertake a human intervention study to test the hypothesis that a broccoli-rich diet can alter the metabolism and gene expression within prostate tissue of men under active surveillance in a manner that would reduce the probability of the emergence and progression of aggressive cancerous clones. Participants recruited onto this study will be randomly allocated to one of three dietary groups in which they will be required to consume one portion per week of a broccoli soup delivering a different concentration of sulforaphane. This will be part of their normal diet for one year.

Blood, urine and prostate biopsy tissue will be obtained before and after a 12 month intervention period. Prostate biopsies will be obtained either though transperineal template biopsies, a technique accepted as best clinical practice because it provides better sampling of the prostate, or transrectal ultrasound guided biopsy which is currently the standard of care for obtaining biopsies.

This study has been funded by Biotechnology and Biological Sciences Research Council (BBSRC) and Prostate Cancer foundation (PCF).

The study is a randomised double-blinded dietary intervention study. The study population will consist of smoking and non-smoking men aged between 18 and 80 years old. Participants recruited into this study will be randomly placed into one of three dietary groups in which they will be required to consume one portion of broccoli soup per week, delivering a different level of glucoraphanin (sulforaphane precursor), as part of their normal diet for one year. The three types of soup will contain (i)standard broccoli, (ii)glucoraphanin-enriched broccoli (Beneforte®), or (iii)Beneforte extra. Beneforte and Beneforte extra broccoli are especially cultivated to deliver high sulforaphane levels after consumption. All the three broccoli varieties have the same appearance and flavour thus enabling a blinded human intervention study to be undertaken. Broccoli soups will be manufactured by a food company that supplies soups to the leading supermarket retailers in the United Kingdom. In order to assess the habitual diet of the participants, they will be asked to keep three 7-day diet diaries, one pre-intervention, after 6-months and another one week before the end of their intervention. Considering the effect of exercise on whole body metabolism we will also obtain information on the physical activity of study participants. They will be asked to complete a validated physical activity questionnaire together with the diet diary (i.e before starting the study diet then at 6 and 12 months). Twenty six participants will be recruited to each of the broccoli groups. The participants will be characterised as having a low or intermediate risk of developing prostate cancer and will be undergoing active surveillance. A number of physiological tests will be performed on the participants before they start the dietary intervention (baseline) and after their 12 months on the intervention. The study will involve collection of prostate biopsies, blood and urine samples at baseline and after a 12 month dietary intervention. Prostate biopsies will be obtained through transperineal template biopsy (TPB) where possible or standard transrectal ultrasound scan guided biopsy (TRUS biopsy). TPB is a clinical procedure carried out under a general or regional anaesthetic which gives more detailed information about the position, amount and aggressiveness of the cancer within the prostate than other standard techniques. However, patients who do not wish to undergo TPB can alternatively choose the standard TRUS biopsy.

At the end of the trial participants will be asked to give written consent if they wish to continue the diet for a further 12 months. Consenting patients will thereafter be required to eat one portion of broccoli soup per week for 12-months. We will not ask participants to attend extra hospital visits for the purpose of the study or give additional biological samples; instead we will capture clinical data related to their follow up of prostate cancer.

It is anticipated that the dropout rate for this study will be approximately 25% due to the clinical progression of prostate cancer within the 12-month study period. In the event of clinical progression the volunteer will discontinue the intervention, receive advice from the urologist in charge and in case of prostatectomy will be asked to donate part of their prostate gland for research purposes.

Effect of Sulforaphane on Prostate CAncer PrEvention

A Human Dietary Intervention Study to Investigate the Effect of Sulforaphane on Prostate Cancer Interception

To determine whether a 12 month diet rich in broccoli will result in changes in global gene expression in prostate tissue from men diagnosed with low- and intermediate- risk prostate cancer on active surveillance.

To determine whether a 12 month diet rich in broccoli will results in changes in levels of metabolites in prostate tissue from men diagnosed with low- and intermediate- risk prostate cancer on active surveillance.

Prostate Cancer Foundation

Biotechnology and Biological Sciences Research Council

Quadram Institute Bioscience

Phenethyl isothiocyanate

Protective Agents

Phenethylisothiocyanate

Four weeks SFN-rich broccoli sprout extract (BSE) capsules: 200µmol of sulforaphane (SFN) daily, 2 capsules (1 capsule B.I.D.) daily

Four weeks placebo capsules: 2 capsules (1 capsule B.I.D.) daily

Four weeks SFN-rich broccoli sprout extract (BSE) capsules: 200µmol of SFN, 2 capsules (1 capsule B.I.D.) daily

SFN-rich broccoli sprout extract capsules

Gelatin capsule containing microcrystalline cellulose.

Jackilen Shannon, PhD

The objective of the study is to identify mechanisms by which compounds found in cruciferous vegetables alter gene expression via epigenetic modifications (changes in gene expression) and may prevent prostate cancer development.

The investigators have found that sulforaphane (SFN), an isothiocyanate found in cruciferous vegetables, inhibits histone deacetylase (HDAC) activity in human colorectal and prostate cancer cells.

Prostate cancer is the most frequently diagnosed non-cutaneous cancer and is the second leading cause of cancer death in American men. The precise etiologic factors that initiate and enhance the progression of prostate cancer remain unknown, but epigenetic alterations and diet/lifestyle factors have come forth as significant contributing factors. Epidemiologic studies suggest that cruciferous vegetable intake decreases the risk for prostate cancer. The long-term goal of this proposal is to identify mechanisms by which dietary compounds, such as those found in cruciferous vegetables decrease prostate cancer risk. The objective of the study is to identify mechanisms by which compounds found in cruciferous vegetables alter gene expression via epigenetic modifications and may prevent prostate cancer development.

The investigators have found that SFN, an isothiocyanate found in cruciferous vegetables, inhibits HDAC activity in human colorectal and prostate cancer cells.

Targeting the epigenome, including the use of HDAC and DNA methyltransferase (DNMT) inhibitors, is an evolving strategy for cancer chemoprevention and both have shown promise in cancer clinical trials.

This Randomized, Double Blind, Clinical Trial will address the following objectives:

1. Identify distribution of SFN and its metabolites and HDAC inhibition following supplementation with an SFN-rich broccoli sprout extract in subjects at risk for prostate cancer (Primary Endpoints)
2. Investigate the effects of supplementation with an SFN-rich broccoli sprout extract on DNA methylation status and proliferation markers in a pre-biopsy setting (secondary analysis)

The effects of short-term supplementation with an SFN-rich broccoli sprout extract on benign epithelial tissue will be studied in men characterized as being at risk for prostate cancer in a randomized, placebo-controlled trial. Men scheduled for prostate biopsy will be recruited into the trial.

Following successful completion of the consent, two 10 mL blood specimens for study analyses, a 4 mL specimen for total bilirubin assessment will be drawn and the subject will provide a urine sample. The study coordinator will explain the Diet History questionnaires (DHQ) and administer the risk factor and adverse event (AE) questionnaires in order to obtain data on potential confounding dietary variables and gain subjects' baseline symptoms.

The study coordinator will provide the subject with a month' supply of either an SFN-rich broccoli sprout extract (BSE) capsule which consist of 200µmol of sulforaphane (SFN) or matching placebo, as dispensed by the Research Pharmacy. The matching placebo for the BSE consists of a gelatin capsule containing microcrystalline cellulose.

Around every 2 weeks, study coordinator will call to complete AE reporting and any changes in medications or supplements and complete brief cruciferous vegetable intake checklist. Subjects will return any unused study "drug" to the study coordinator at the time of biopsy (or at the 4 week visit if subject's prostate biopsy is delayed).

Chemoprevention of Prostate Cancer, HDAC Inhibition and DNA Methylation

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

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

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adherence Dynamics for Whole Food Interventions in African-American Men	NCT01408459	Healthy	Tomato Product Control	50 Years -	University of Illinois at Chicago
"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk	NCT00056407	Neoplasms, Pros...	Dutasteride Placebo	50 Years - 75 Years	GlaxoSmithKline
Effect of Sulforaphane on Prostate CAncer PrEvention	NCT01950143	Prostate Cancer	Standard brocco... Beneforte brocc... Beneforte extra...	18 Years - 80 Years	Quadram Institute Bioscience
Chemoprevention of Prostate Cancer, HDAC Inhibition and DNA Methylation	NCT01265953	Prostate Cancer...	SFN-rich brocco... Gelatin capsule...	21 Years -	Portland VA Medical Center
Adherence Dynamics for Whole Food Interventions in African-American Men	NCT01408459	Healthy	Tomato Product Control	50 Years -	University of Illinois at Chicago
Effect of Sulforaphane on Prostate CAncer PrEvention	NCT01950143	Prostate Cancer	Standard brocco... Beneforte brocc... Beneforte extra...	18 Years - 80 Years	Quadram Institute Bioscience

Spots Global Cancer Trial Database for prostate cancer prevention