Trial · NCT01325311
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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 |
| Secondary | Total IGFBP-3 in Serum at Baseline and Pre-Surgery | Baseline and Up to Day 35 | This is measuring the concentration of the Biomarker IGFBP-3 in blood serum at Baseline and at the end of the study. |
| Secondary | Total PTH in Serum at Baseline and Pre-Surgery | Baseline and Up to Day 35 | This is measuring the concentration of the Biomarker PTH in blood serum at Baseline and at the end of the study |
| Secondary | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | Up to Day 35 | The Immunohistochemistry measurement for: AR (Nucleus), VDR (Cytoplasm), p21 (Nucleus), PGE2 (Cytoplasm), TUNEL Pos (Nucleus), Caspase 3 (Cytoplasm), PSMA (Cytoplasm), IGF-1 and IGF-2 (Cytoplasm), Akt (Nucleus and Cytoplasm), and pAkt (nucleus and Cytoplasm) This is to serve as normalized control data to determine expression of protein. The normalized optical densities were measured as optical density per unit area by densitometric scanning using Vectra imaging system (Perkin Elmer). This Optical Density is based on fluorescence. |
| Secondary | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | Up to day Day 35 | The Immunohistochemistry measurement for: AR (Nucleus), VDR (Cytoplasm), p21 (Nucleus), PGE2 (Cytoplasm), TUNEL Pos (Nucleus), Caspase 3 (Cytoplasm), PSMA (Cytoplasm), IGF-1 and IGF-2 (Cytoplasm), Akt (Nucleus and Cytoplasm), and pAkt (nucleus and Cytoplasm) This is to serve as normalized case data to determine expression of protein. The normalized optical densities were measured as optical density per unit area by densitometric scanning using Vectra imaging system (Perkin Elmer). This Optical Density is based on fluorescence. |
| Secondary | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | up to Day 35 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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