Trial · NCT01325311
Cholecalciferol and Genistein Before Surgery in Treating Patients With Early Stage Prostate Cancer
NCT01325311, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2016-08-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cholecalciferol and Genistein Before Surgery in Treating Patients With Early Stage Prostate Cancer. Trials, record NCT01325311. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01325311
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cholecalciferol and Genistein Before Surgery in Treating Patients With Early Stage Prostate Cancer
- NCT number
- NCT01325311
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Prostate Adenocarcinoma, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
- Interventions
- Cholecalciferol, Genistein, Laboratory Biomarker Analysis, Pharmacological Study, Placebo
- First posted
- 2011-03-29
- Last updated
- 2016-08-03
- Results first posted
- 2016-08-03
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms | up to Day 35 | This is a measure of calcitriol in prostate tissue comparing placebo and cholecalciferol/genistein |
| Primary | Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms | up to 35 days | To identify the amount of Calcitriol that is found in the tissue comparing Placebo and Cholecalciferol/Genistein |
| Secondary | Levels of Calcidiol in the Participants Serum | Baseline and up to day 35 | This is measuring the amount of Calcidiol that was found in the participants blood Serum at baseline and end of study |
| Secondary | Levels of Calcitriol in Participants Serum | baseline and Up to Day 35 | This is measuring the amount of Calcitriol that was found in the participants blood Serum at baseline and end of study. |
| Secondary | PBMC CYP mRNA Expression of CYP24 | Baseline and Up to Day 35 | This is a measure of expression of CYP24 in comparing placebo to Cholecalciferol/genistein. |
| Secondary | PBMC CYP mRNA Expression of CYP27B1 | Up to Day 35 | This is a measure of expression of CYP27B1 in comparing placebo to Cholecalciferol/genistein. |
| Secondary | Total PSA in Serum | at Baseline and up to Day 35 | This is a measure of the concentration of PSA in the blood serum at baseline and at the end of study. |
| Secondary | Serum Calcium Levels at Baseline and Pre-Surgery | Baseline and Day 35 | This is a measurement of calcium in the Blood serum at baseline and at the end of the study. |
| Secondary | Total IGF-1 in Serum at Baseline and Pre-Surgery | Baseline and up to Day 35 | This is measuring the concentration of the Biomarker IGF-1 in blood serum at Baseline and at the end of the study. |
| Secondary | Total IGF-2 in Serum at Baseline and Pre-Surgery | Baseline and Up to Day 35 | This is measuring the concentration of the Biomarker IGF-2 in blood serum at Baseline and at the end of the study |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms | up to Day 35 | ng/mL | MEAN | |
| SECONDARY | Levels of Calcidiol in the Participants Serum | Baseline and up to day 35 | Due to sample one participant in Arm 1 was not analyzed for this Outcome. | ng/mL | MEAN |
| PRIMARY | Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms | up to 35 days | participants | NUMBER | |
| SECONDARY | Levels of Calcitriol in Participants Serum | baseline and Up to Day 35 | Due to sample one participant in Arm 1 was not analyzed for this Outcome. | ng/mL | MEAN |
| SECONDARY | PBMC CYP mRNA Expression of CYP24 | Baseline and Up to Day 35 | Due to sample two participant in Arm I and 2 participants in Arm II were not analyzed for this Outcome. | Ratio to Baseline | GEOMETRIC_MEAN |
| SECONDARY | PBMC CYP mRNA Expression of CYP27B1 | Up to Day 35 | Ratio to Baseline | GEOMETRIC_MEAN | |
| SECONDARY | Total PSA in Serum | at Baseline and up to Day 35 | Due to sample one participant in Arm I was not analyzed for this Outcome. | ng/mL | MEDIAN |
| SECONDARY | Serum Calcium Levels at Baseline and Pre-Surgery | Baseline and Day 35 | Due to sample one participant in Arm I was not analyzed for this Outcome. | ng/mL (absolute change) | MEAN |
| SECONDARY | Total IGF-1 in Serum at Baseline and Pre-Surgery | Baseline and up to Day 35 | Due to sample one participant in Arm I was not analyzed for this Outcome. | ng/mL | MEAN |
| SECONDARY | Total IGF-2 in Serum at Baseline and Pre-Surgery | Baseline and Up to Day 35 | Due to sample one participant in Arm 1 was not analyzed. | ng/mL | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group126
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms | Arm II (Placebo) | 0.045 | Standard Deviation 0.127 | ng/mL | |
| Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms | Arm I (Cholecalciferol, Genistein) | 0.057 | Standard Deviation 0.150 | ng/mL | |
| Levels of Calcidiol in the Participants Serum | Arm II (Placebo) | Baseline | 20.5 | Standard Deviation 5.5 | ng/mL |
| Levels of Calcidiol in the Participants Serum | Arm I (Cholecalciferol, Genistein) | Baseline | 24.5 | Standard Deviation 9.3 | ng/mL |
| Levels of Calcidiol in the Participants Serum | Arm II (Placebo) | Pre-Surgery | 19.2 | Standard Deviation 5.1 | ng/mL |
| Levels of Calcidiol in the Participants Serum | Arm I (Cholecalciferol, Genistein) | Pre-Surgery | 27.3 | Standard Deviation 10.0 | ng/mL |
| Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms | Arm II (Placebo) | Undetectable | 7 | participants | |
| Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms | Arm I (Cholecalciferol, Genistein) | Undetectable | 6 | participants | |
| Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms | Arm II (Placebo) | Detectable | 1 | participants | |
| Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms | Arm I (Cholecalciferol, Genistein) | Detectable | 1 | participants |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm II (Placebo) | 8 | |
| Overall Study | STARTED | Arm I (Cholecalciferol, Genistein) | 7 | |
| Overall Study | COMPLETED | Arm II (Placebo) | 8 | |
| Overall Study | COMPLETED | Arm I (Cholecalciferol, Genistein) | 7 | |
| Overall Study | NOT COMPLETED | Arm II (Placebo) | 0 | |
| Overall Study | NOT COMPLETED | Arm I (Cholecalciferol, Genistein) | 0 |
Source ClinicalTrials.gov
Adverse events30
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 |
|---|---|---|---|---|---|---|
| other | hyperthyriodism | Endocrine disorders | Arm II (Placebo) | 1 | 8 | 1 |
| other | hyperthyriodism | Endocrine disorders | Arm I (Cholecalciferol, Genistein) | 0 | 7 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Arm II (Placebo) | 0 | 8 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Arm I (Cholecalciferol, Genistein) | 2 | 7 | 2 |
| other | diarrhea | Gastrointestinal disorders | Arm II (Placebo) | 0 | 8 | 0 |
| other | diarrhea | Gastrointestinal disorders | Arm I (Cholecalciferol, Genistein) | 2 | 7 | 2 |
| other | fatigue | General disorders | Arm II (Placebo) | 1 | 8 | 1 |
| other | fatigue | General disorders | Arm I (Cholecalciferol, Genistein) | 0 | 7 | 0 |
| other | pain | General disorders | Arm II (Placebo) | 0 | 8 | 0 |
| other | pain | General disorders | Arm I (Cholecalciferol, Genistein) | 1 | 7 | 1 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm II (Placebo) | ||
| Total, all-cause mortality | Arm I (Cholecalciferol, Genistein) | ||
| Total, other adverse events | Arm II (Placebo) | 4 | 8 |
| Total, other adverse events | Arm I (Cholecalciferol, Genistein) | 5 | 7 |
| Total, serious adverse events | Arm II (Placebo) | 0 | 8 |
| Total, serious adverse events | Arm I (Cholecalciferol, Genistein) | 0 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| P30CA014520 | UW Comprehensive Cancer Center Support | CAPITINI, CHRISTIAN | UNIVERSITY OF WISCONSIN-MADISON | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| 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 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I (Cholecalciferol, Genistein) vs Arm II (Placebo): serious adverse events |
Source Trial comparisons
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/NCT01325311
GET https://conductscience.org/api/trials/v1/NCT01325311/results?page=2