Trial · NCT00450229
Diindolylmethane in Treating Patients Undergoing Surgery for Stage I or Stage II Prostate Cancer
NCT00450229, Phase 1, Completed, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Diindolylmethane in Treating Patients Undergoing Surgery for Stage I or Stage II Prostate Cancer. Trials, record NCT00450229. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00450229
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Diindolylmethane in Treating Patients Undergoing Surgery for Stage I or Stage II Prostate Cancer
- NCT number
- NCT00450229
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 45 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adenocarcinoma of the Prostate, Prostate Cancer, Stage I Prostate Cancer, Stage II Prostate Cancer
- Interventions
- diindolylmethane, placebo, therapeutic conventional surgery, laboratory biomarker analysis, pharmacological study
- First posted
- 2007-03-22
- Last updated
- 2015-12-04
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tissue levels of DIM | Up to 5 years | The distribution of levels of DIM will be summarized by treatment arm with descriptive statistics. For the primary comparison between the placebo group and the DIM groups combined, tissue levels of DIM will be compared using Student t-test. In the case of violation of normality assumptions, an appropriate transformation of the data such as logarithm will be considered or a nonparametric test such as Wilcoxon rank-sum test will be used for comparison. A dose-response relation will be explored based on the analysis of covariance (ANCOVA). |
| Secondary | Urinary 2-hydroxyestrone/16-hydroxyestrone ratio | Up to 5 years | Will be summarized by treatment arm with descriptive statistics. |
| Secondary | Total PSA | Up to 5 years | Will be summarized by treatment arm with descriptive statistics. |
| Secondary | Serum testosterone | Up to 5 years | Will be summarized by treatment arm with descriptive statistics. |
| Secondary | IGF1:IGFBP-3 ratio | Up to 5 years | Will be summarized by treatment arm with descriptive statistics. |
| Secondary | Tissue measures of messenger RNA of CYPs (CYP1A2, CYP1A1, CYP2B1, CYP3A) | Up to 5 years | Will be summarized by treatment arm with descriptive statistics. |
| Secondary | DIM blood steady-state concentrations | Up to 5 years | Will be summarized by treatment arm with descriptive statistics. |
| Secondary | Measures of androgen receptor, PSA, Ki-67, caspase 3, and TUNEL | Up to 5 years | Will be summarized by treatment arm with descriptive statistics. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| N01CN035153 | PHASE 1 AND PHASE 2 CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS --261035153 | BAILEY, HOWARD H. | UNIVERSITY OF WISCONSIN - MAD | DIVISION OF CANCER PREVENTION AND CONTROL | 2004 to 2006 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00450229
GET https://conductscience.org/api/trials/v1/NCT00450229/registered