NCT00607932

Brief Summary

RATIONALE: Eating a diet high in vegetables may lower the risk of some types of cancer. Brassica vegetables (such as cabbages, kale, broccoli, Brussels sprouts, and cauliflower) and indole-3-carbinol (a substance found in cruciferous vegetables) may help lower the risk of prostate cancer recurrence. PURPOSE: This randomized clinical trial is studying the side effects and how well Brassica vegetables work compared with indole-3-carbinol in treating patients with PSA recurrence after surgery for prostate cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2005

Longer than P75 for not_applicable prostate-cancer

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

Study Start

First participant enrolled

March 1, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

1.8 years

First QC Date

February 1, 2008

Last Update Submit

April 26, 2016

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer

Outcome Measures

Primary Outcomes (3)

  • Feasibility of Brassica vegetable intake and indole-3-carbinol supplementation

    will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention

  • Adverse events

    will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention

  • Effects of intervention on prostate-specific antigen

    Not noted

Study Arms (2)

Brassica Vegetables Diet Intervention

EXPERIMENTAL
Behavioral: behavioral dietary interventionDietary Supplement: Brassica vegetableDrug: indole-3-carbinolOther: counseling interventionOther: medical chart reviewOther: questionnaire administrationProcedure: adjuvant therapy

Pill

EXPERIMENTAL
Drug: indole-3-carbinolOther: counseling interventionOther: medical chart reviewOther: questionnaire administrationProcedure: adjuvant therapy

Interventions

behavioral dietary interventionBEHAVIORAL
Brassica Vegetables Diet Intervention
Brassica vegetableDIETARY_SUPPLEMENT
Brassica Vegetables Diet Intervention
indole-3-carbinolDRUG

follow up at 2,4,6 months post baseline.

Also known as: I3C
Brassica Vegetables Diet InterventionPill
counseling interventionOTHER

2, 4, 6 months post baseline

Brassica Vegetables Diet InterventionPill
medical chart reviewOTHER

2,4,6 months post baseline

Brassica Vegetables Diet InterventionPill
questionnaire administrationOTHER
Brassica Vegetables Diet InterventionPill
adjuvant therapyPROCEDURE
Brassica Vegetables Diet InterventionPill

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of prostate cancer with PSA recurrence after prostatectomy
  • PSA recurrence is defined as two consecutively rising PSA tests ≥ 8 weeks since the post-surgical nadir, with a minimal interval of 2 weeks between tests and at least 1 PSA test \> 0.4 ng/mL

You may not qualify if:

  • Life expectancy ≥ 9 months
  • No predictors of poor adherence (e.g., erratic life-style, mental incompetence)
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No other concurrent Brassica vegetable consumption \> 1 serving/day
  • No other concurrent indole-3-carbinol supplements
  • No endocrine or radiation treatment within past 4 weeks
  • No other scheduled treatment during study intervention
  • Concurrent prescription medications during the trial allowed
  • At least 2 weeks since prior and no concurrent vitamin or herbal supplement use
  • Patients refusing to stop non-study supplements will be asked to maintain constant use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

indole-3-carbinolCounselingChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Jay H. Fowke, PhD, MPH

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 1, 2008

First Posted

February 6, 2008

Study Start

March 1, 2005

Primary Completion

January 1, 2007

Study Completion

November 1, 2010

Last Updated

April 27, 2016

Record last verified: 2016-04