Prostate CancerPhase 1/2PHASENCT00946309
Effects of Sulforaphane on Normal Prostate Tissue
A Phase 1/2 study testing High Sulforaphane Extract (Broccoli Sprout Extract) in people with Prostate Cancer, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- High Sulforaphane Extract (Broccoli Sprout Extract)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to May 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vivo Effects of Sulforaphane Supplementation on Normal Human Prostate
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
- Prostate Cancer
- Being tested
- High Sulforaphane Extract (Broccoli Sprout Extract), Microcrystalline Cellulose NF (placebo)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Sulforaphane Extract (Broccoli Sprout Extract)Drug
Also called Broccoli Sprout Extract
100 umol sulforaphane, every other day for 5 weeks
Microcrystalline Cellulose NF (placebo)Drug
250 mg every other day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| High Sulforaphane Extract | Experimental | Not described Receives: Drug: High Sulforaphane Extract (Broccoli Sprout Extract) |
| Placebo | Placebo comparator | Not described Receives: Drug: Microcrystalline Cellulose NF (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene Expression of Phase II Enzymes
Change in Phase II enzyme expression
Measured: Baseline and 5 weeks
Lipid Oxidation
Blood F2 Isoprostane levels
Measured: Baseline and 5 weeks
DNA Oxidation
Prostate tissue 8-hydroxy-2'-deoxyguanosine (8OHdG) levels
Measured: Five weeks
DHT Levels
Change in serum dihydrotestosterone (DHT) levels
Measured: Baseline and 5 weeks
Testosterone Levels
Change in testosterone (T) levels
Measured: Baseline and 5 weeks
3-alpha-diol Gluconate Levels
Change in serum 3-alpha-diol gluconate(3α-DG) levels
Measured: Baseline and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startJul 2010
- Primary completionMay 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Daniel Lin, Fred Hutchinson Cancer Center
- Investigators
- Daniel W Lin, MD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946309
- Sponsor's protocol ID
- PHS 2333.00
- Other IDs
- 6969
- Acronym
- PHASE
- Status last verified
- Jun 2016
- First submitted
- 23 Jul 2009
- Last updated
- 15 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Effects of Sulforaphane Supplementation on Normal Human Prostate
- ClinicalTrials.gov ID
- NCT00946309
- Acronym / sponsor ID
- PHASE / PHS 2333.00
- Conditions
- Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- VA Puget Sound Health Care System, Seattle Institute for Biomedical and Clinical Research, Johns Hopkins University, University of Washington, Cedars-Sinai Medical Center
- Study start
- Jul 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 27 Jul 2009 (estimated)
- Results
- Posted 15 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Sulforaphane Extract | Experimental | Drug: High Sulforaphane Extract (Broccoli Sprout Extract) |
| Placebo | Placebo comparator | Drug: Microcrystalline Cellulose NF (placebo) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Sulforaphane Extract (Broccoli Sprout Extract)Also: Broccoli Sprout Extract100 umol sulforaphane, every other day for 5 weeks | Drug | High Sulforaphane Extract |
| Microcrystalline Cellulose NF (placebo)250 mg every other day for 6 weeks | Drug | Placebo |
Primary outcome
Gene Expression of Phase II Enzymes
Time frame: Baseline and 5 weeks
Change in Phase II enzyme expression
Lipid Oxidation
Time frame: Baseline and 5 weeks
Blood F2 Isoprostane levels
DNA Oxidation
Time frame: Five weeks
Prostate tissue 8-hydroxy-2'-deoxyguanosine (8OHdG) levels
DHT Levels
Time frame: Baseline and 5 weeks
Change in serum dihydrotestosterone (DHT) levels
Testosterone Levels
Time frame: Baseline and 5 weeks
Change in testosterone (T) levels
3-alpha-diol Gluconate Levels
Time frame: Baseline and 5 weeks
Change in serum 3-alpha-diol gluconate(3α-DG) levels
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Prostate Cancer
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RecruitingPhase 1/2
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RecruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel W Lin, MD principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing High Sulforaphane Extract (Broccoli Sprout Extract) in people with Prostate Cancer, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene Expression of Phase II Enzymes (time frame: Baseline and 5 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.