NCT00946309

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1 prostate-cancer

Timeline
Completed

Started Jul 2010

Typical duration for phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

November 15, 2016

Completed
Last Updated

November 15, 2016

Status Verified

June 1, 2016

Enrollment Period

3.8 years

First QC Date

July 23, 2009

Results QC Date

August 20, 2015

Last Update Submit

September 24, 2016

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (6)

  • Gene Expression of Phase II Enzymes

    Change in Phase II enzyme expression

    Baseline and 5 weeks

  • Lipid Oxidation

    Blood F2 Isoprostane levels

    Baseline and 5 weeks

  • DNA Oxidation

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

    Five weeks

  • DHT Levels

    Change in serum dihydrotestosterone (DHT) levels

    Baseline and 5 weeks

  • Testosterone Levels

    Change in testosterone (T) levels

    Baseline and 5 weeks

  • 3-alpha-diol Gluconate Levels

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

    Baseline and 5 weeks

Study Arms (2)

High Sulforaphane Extract

EXPERIMENTAL
Drug: High Sulforaphane Extract (Broccoli Sprout Extract)

Placebo

PLACEBO COMPARATOR
Drug: Microcrystalline Cellulose NF (placebo)

Interventions

High Sulforaphane Extract (Broccoli Sprout Extract)DRUG

100 umol sulforaphane, every other day for 5 weeks

Also known as: Broccoli Sprout Extract
High Sulforaphane Extract
Microcrystalline Cellulose NF (placebo)DRUG

250 mg every other day for 6 weeks

Placebo

Eligibility Criteria

Age40 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Dr. Daniel Lin
Organization
Fred Hutchinson Cancer Research Center
dwlin@uw.edu
206-221-0797

Study Officials

  • Daniel W Lin, MD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 27, 2009

Study Start

July 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2015

Last Updated

November 15, 2016

Results First Posted

November 15, 2016

Record last verified: 2016-06

Locations

US(1)