Trial · NCT00888654
Diindolylmethane in Treating Patients With Stage I or Stage II Prostate Cancer Undergoing Radical Prostatectomy
NCT00888654, Phase 2, Completed, Barbara Ann Karmanos Cancer Institute; results first posted 2015-03-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Diindolylmethane in Treating Patients With Stage I or Stage II Prostate Cancer Undergoing Radical Prostatectomy. Trials, record NCT00888654. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00888654
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Diindolylmethane in Treating Patients With Stage I or Stage II Prostate Cancer Undergoing Radical Prostatectomy
- NCT number
- NCT00888654
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Conditions
- Prostate Cancer
- Interventions
- B-Dim, Radical Prosatectomy
- First posted
- 2009-04-27
- Last updated
- 2018-03-19
- Results first posted
- 2015-03-30
- Limitations and caveats
- There were no significant limitations.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Level of Diindolylmethane in Prostate Tissue After Treatment | Within the first 24 months after radical prostatectomy. | |
| Secondary | Serum Levels of PSA, Testosterone, and Diindolylmethane | Pre and post radical prostatectomy | Serum levels of PSA, testosterone, and diindolylmethane (DIM) |
| Secondary | Levels of Androgen Receptor in Prostate Tissue | Pre and post radical prostatectomy | Levels of androgen receptor in prostate tissue as measured by AR score (intensity x % cells stained), higher scores indicate higher levels of androgen receptor in prostate tissue. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Level of Diindolylmethane in Prostate Tissue After Treatment | Within the first 24 months after radical prostatectomy. | Patients that were eligible, evaluable, and compliant | ng/g | MEAN |
| SECONDARY | Serum Levels of PSA, Testosterone, and Diindolylmethane | Pre and post radical prostatectomy | All enrolled patients except for one patient who was deemed ineligible due to a disallowed concomitant medication and for one patient whose prostatectomy was cancelled because of adhesions found at the time of surgery. | ng/ml | MEDIAN |
| SECONDARY | Levels of Androgen Receptor in Prostate Tissue | Pre and post radical prostatectomy | All enrolled patients except for one patient who was deemed ineligible due to a disallowed concomitant medication and for one patient whose prostatectomy was cancelled because of adhesions found at the time of surgery. | AR score (intensity x % cells stained) | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Level of Diindolylmethane in Prostate Tissue After Treatment | B-Dim, Radical Prosatectomy | 14.2 | 90% Confidence Interval 10.6 to 17.7 | ng/g | |
| Serum Levels of PSA, Testosterone, and Diindolylmethane | B-Dim, Radical Prosatectomy | Pre-treatment PSA | 6.4 | Full Range 2.1 to 29.4 | ng/ml |
| Serum Levels of PSA, Testosterone, and Diindolylmethane | B-Dim, Radical Prosatectomy | Post-treatment PSA | 5.8 | Full Range 2.6 to 28.3 | ng/ml |
| Serum Levels of PSA, Testosterone, and Diindolylmethane | B-Dim, Radical Prosatectomy | Pre-treatment Testosterone | 301 | Full Range 77 to 608 | ng/ml |
| Serum Levels of PSA, Testosterone, and Diindolylmethane | B-Dim, Radical Prosatectomy | Post-treatment Testosterone | 388 | Full Range 110 to 686 | ng/ml |
| Serum Levels of PSA, Testosterone, and Diindolylmethane | B-Dim, Radical Prosatectomy | Pre-treatment DIM | 0.0 | Full Range 0.0 to 0.0 | ng/ml |
| Serum Levels of PSA, Testosterone, and Diindolylmethane | B-Dim, Radical Prosatectomy | Post-treatment DIM | 7.5 | Full Range 0.0 to 24.7 | ng/ml |
| Levels of Androgen Receptor in Prostate Tissue | B-Dim, Radical Prosatectomy | Pre-BR-DIM Androgen Receptor | 278 | 90% Confidence Interval 263 to 293 | AR score (intensity x % cells stained) |
| Levels of Androgen Receptor in Prostate Tissue | B-Dim, Radical Prosatectomy | Post-BR-DIM Androgen Receptor | 245 | 90% Confidence Interval 227 to 263 | AR score (intensity x % cells stained) |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | B-Dim, Radical Prosatectomy | 41 | |
| Overall Study | COMPLETED | B-Dim, Radical Prosatectomy | 31 | |
| Overall Study | NOT COMPLETED | B-Dim, Radical Prosatectomy | 10 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Headache | Nervous system disorders | B-Dim, Radical Prosatectomy | 2 | 41 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | B-Dim, Radical Prosatectomy | ||
| Total, other adverse events | B-Dim, Radical Prosatectomy | 0 | 41 |
| Total, serious adverse events | B-Dim, Radical Prosatectomy | 2 | 41 |
Source ClinicalTrials.gov
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 |
|---|---|---|---|---|---|
| P30CA022453 | CANCER CENTER SUPPORT GRANT | PASCHE, BORIS | WAYNE STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
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/NCT00888654
GET https://conductscience.org/api/trials/v1/NCT00888654/registered