Biochemical FailurePhase 2/3NCT00579332
Effects of Brassica or Indole-3-carbinol on Prostatectomy Patients With PSA Recurrence
A Phase 2/3 study testing brassica intervention in people with Biochemical Failure, run by Vanderbilt University at 1 site in United States.
Trial summary
Pilot and feasibility diet and phyto-agent intervention among healthy men at risk for prostate cancer progression. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Biochemical Failure
- What is being tested?
- brassica intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Dec 2006
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with PSA recurrence following prostatectomy
Who cannot join
- Not using exogenous hormones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Brassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrenc
Pilot and feasibility diet and phyto-agent intervention among healthy men at risk for prostate cancer progression.
- Conditions
- Biochemical Failure
- Being tested
- brassica intervention
- Keywords
- PSA, biochemical failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brassica interventionDietary supplement
diet and phyto-chemical intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | one a day placebo Receives: Dietary Supplement: brassica intervention |
| 2 | Experimental | Brassica intake Receives: Dietary Supplement: brassica intervention |
| 3 | Experimental | indole-3-carbinol supplement Receives: Dietary Supplement: brassica intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in blood PSA levels
Measured: 6 months
Secondary outcomes (1)
monitor for health events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startJan 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biochemical FailureStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- American Institute of Cancer Prevention
- Responsible party
- Principal investigator, Jay Fowke, Vanderbilt University
- Investigators
- Jay H Fowke, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579332
- Sponsor's protocol ID
- 041001
- Status last verified
- Apr 2016
- First submitted
- 18 Dec 2007
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Brassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrenc
- ClinicalTrials.gov ID
- NCT00579332
- Acronym / sponsor ID
- 041001
- Conditions
- Biochemical Failure
- Keywords
- PSA, biochemical failure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- American Institute of Cancer Prevention
- Study start
- Jan 2005
- Study completion
- Dec 2006 (actual)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot and feasibility diet and phyto-agent intervention among healthy men at risk for prostate cancer progression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: brassica interventionone a day placebo |
| 2 | Experimental | Dietary Supplement: brassica interventionBrassica intake |
| 3 | Experimental | Dietary Supplement: brassica interventionindole-3-carbinol supplement |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men with PSA recurrence following prostatectomy
Key exclusion criteria (1 listed)
- Not using exogenous hormones
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 |
|---|---|---|
| brassica interventiondiet and phyto-chemical intervention | Dietary supplement | 1, 2, 3 |
Primary outcome
change in blood PSA levels
Time frame: 6 months
1 secondary outcome
monitor for health events
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
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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.
Jay H Fowke, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing brassica intervention in people with Biochemical Failure, run by Vanderbilt University 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 1 inclusion and 1 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 27 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in blood PSA levels (time frame: 6 months). 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 27 Apr 2016.