Trial Outcomes & Findings for Cholecalciferol and Genistein Before Surgery in Treating Patients With Early Stage Prostate Cancer (NCT NCT01325311)
NCT ID: NCT01325311
Last Updated: 2016-08-03
Results Overview
This is a measure of calcitriol in prostate tissue comparing placebo and cholecalciferol/genistein
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
up to Day 35
Results posted on
2016-08-03
Participant Flow
Participant milestones
| Measure |
Arm II (Placebo)
Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
Arm I (Cholecalciferol, Genistein)
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cholecalciferol and Genistein Before Surgery in Treating Patients With Early Stage Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm II (Placebo)
n=8 Participants
Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
Arm I (Cholecalciferol, Genistein)
n=7 Participants
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
60.75 years
STANDARD_DEVIATION 4.50 • n=5 Participants
|
62.14 years
STANDARD_DEVIATION 4.26 • n=7 Participants
|
61.40 years
STANDARD_DEVIATION 4.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to Day 35This is a measure of calcitriol in prostate tissue comparing placebo and cholecalciferol/genistein
Outcome measures
| Measure |
Arm II (Placebo)
n=8 Participants
Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
Arm I (Cholecalciferol, Genistein)
n=7 Participants
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms
|
0.045 ng/mL
Standard Deviation 0.127
|
0.057 ng/mL
Standard Deviation 0.150
|
PRIMARY outcome
Timeframe: up to 35 daysTo identify the amount of Calcitriol that is found in the tissue comparing Placebo and Cholecalciferol/Genistein
Outcome measures
| Measure |
Arm II (Placebo)
n=8 Participants
Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
Arm I (Cholecalciferol, Genistein)
n=7 Participants
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms
Undetectable
|
7 participants
|
6 participants
|
|
Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms
Detectable
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline and up to day 35Population: Due to sample one participant in Arm 1 was not analyzed for this Outcome.
This is measuring the amount of Calcidiol that was found in the participants blood Serum at baseline and end of study
Outcome measures
| Measure |
Arm II (Placebo)
n=8 Participants
Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
Arm I (Cholecalciferol, Genistein)
n=6 Participants
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Levels of Calcidiol in the Participants Serum
Baseline
|
20.5 ng/mL
Standard Deviation 5.5
|
24.5 ng/mL
Standard Deviation 9.3
|
|
Levels of Calcidiol in the Participants Serum
Pre-Surgery
|
19.2 ng/mL
Standard Deviation 5.1
|
27.3 ng/mL
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: baseline and Up to Day 35Population: Due to sample one participant in Arm 1 was not analyzed for this Outcome.
This is measuring the amount of Calcitriol that was found in the participants blood Serum at baseline and end of study.
Outcome measures
| Measure |
Arm II (Placebo)
n=8 Participants
Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
Arm I (Cholecalciferol, Genistein)
n=6 Participants
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Levels of Calcitriol in Participants Serum
Baseline
|
0.5 ng/mL
Standard Deviation 0.1
|
0.5 ng/mL
Standard Deviation 0.2
|
|
Levels of Calcitriol in Participants Serum
Pre-Surgery
|
0.5 ng/mL
Standard Deviation 0.7
|
0.1 ng/mL
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 35Population: Due to sample two participant in Arm I and 2 participants in Arm II were not analyzed for this Outcome.
This is a measure of expression of CYP24 in comparing placebo to Cholecalciferol/genistein.
Outcome measures
| Measure |
Arm II (Placebo)
n=6 Participants
Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
Arm I (Cholecalciferol, Genistein)
n=5 Participants
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|
|
PBMC CYP mRNA Expression of CYP24
|
3.054 Ratio to Baseline
Standard Deviation 3.997
|
2.202 Ratio to Baseline
Standard Deviation 4.071
|
SECONDARY outcome
Timeframe: Up to Day 35This is a measure of expression of CYP27B1 in comparing placebo to Cholecalciferol/genistein.
Outcome measures
| Measure |
Arm II (Placebo)
n=8 Participants
Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
Arm I (Cholecalciferol, Genistein)
n=7 Participants
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|
|
PBMC CYP mRNA Expression of CYP27B1
|
1.656 Ratio to Baseline
Standard Deviation 2.628
|
2.389 Ratio to Baseline
Standard Deviation 3.511
|
SECONDARY outcome
Timeframe: at Baseline and up to Day 35Population: Due to sample one participant in Arm I was not analyzed for this Outcome.
This is a measure of the concentration of PSA in the blood serum at baseline and at the end of study.
Outcome measures
| Measure |
Arm II (Placebo)
n=8 Participants
Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
Arm I (Cholecalciferol, Genistein)
n=6 Participants
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Total PSA in Serum
Baseline
|
8.7 ng/mL
Standard Deviation 7.3
|
6.3 ng/mL
Standard Deviation 1.7
|
|
Total PSA in Serum
Day 35
|
8.3 ng/mL
Standard Deviation 6.7
|
5.8 ng/mL
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline and Day 35Population: Due to sample one participant in Arm I was not analyzed for this Outcome.
This is a measurement of calcium in the Blood serum at baseline and at the end of the study.
Outcome measures
| Measure |
Arm II (Placebo)
n=8 Participants
Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
Arm I (Cholecalciferol, Genistein)
n=6 Participants
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Serum Calcium Levels at Baseline and Pre-Surgery
Baseline
|
10.5 ng/mL (absolute change)
Standard Deviation 0.4
|
11.3 ng/mL (absolute change)
Standard Deviation 1.8
|
|
Serum Calcium Levels at Baseline and Pre-Surgery
Day 35
|
10.8 ng/mL (absolute change)
Standard Deviation 0.9
|
10.9 ng/mL (absolute change)
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline and up to Day 35Population: Due to sample one participant in Arm I was not analyzed for this Outcome.
This is measuring the concentration of the Biomarker IGF-1 in blood serum at Baseline and at the end of the study.
Outcome measures
| Measure |
Arm II (Placebo)
n=8 Participants
Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
Arm I (Cholecalciferol, Genistein)
n=6 Participants
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Total IGF-1 in Serum at Baseline and Pre-Surgery
Baseline
|
64.2 ng/mL
Standard Deviation 11.5
|
66.3 ng/mL
Standard Deviation 12.8
|
|
Total IGF-1 in Serum at Baseline and Pre-Surgery
Day 35
|
60.6 ng/mL
Standard Deviation 17.9
|
74.6 ng/mL
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 35Population: Due to sample one participant in Arm 1 was not analyzed.
This is measuring the concentration of the Biomarker IGF-2 in blood serum at Baseline and at the end of the study
Outcome measures
| Measure |
Arm II (Placebo)
n=8 Participants
Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
Arm I (Cholecalciferol, Genistein)
n=6 Participants
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Total IGF-2 in Serum at Baseline and Pre-Surgery
Pre-Surgery
|
605.0 ng/mL
Standard Deviation 175.4
|
858.8 ng/mL
Standard Deviation 112.7
|
|
Total IGF-2 in Serum at Baseline and Pre-Surgery
Baseline
|
770.4 ng/mL
Standard Deviation 333.4
|
805.9 ng/mL
Standard Deviation 193.5
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 35Population: Due to sample one participant from Arm 1 was not analyzed.
This is measuring the concentration of the Biomarker IGFBP-3 in blood serum at Baseline and at the end of the study.
Outcome measures
| Measure |
Arm II (Placebo)
n=8 Participants
Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
Arm I (Cholecalciferol, Genistein)
n=6 Participants
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Total IGFBP-3 in Serum at Baseline and Pre-Surgery
Baseline
|
1838.9 ng/mL
Standard Deviation 887.3
|
2004.5 ng/mL
Standard Deviation 309.8
|
|
Total IGFBP-3 in Serum at Baseline and Pre-Surgery
Day 35
|
1667.5 ng/mL
Standard Deviation 788.9
|
1843.4 ng/mL
Standard Deviation 443.3
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 35Population: Due to sample one participant in Arm I was not analyzed.
This is measuring the concentration of the Biomarker PTH in blood serum at Baseline and at the end of the study
Outcome measures
| Measure |
Arm II (Placebo)
n=8 Participants
Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
Arm I (Cholecalciferol, Genistein)
n=6 Participants
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Total PTH in Serum at Baseline and Pre-Surgery
Baseline
|
143.4 ng/mL
Standard Deviation 26.5
|
144.8 ng/mL
Standard Deviation 37.8
|
|
Total PTH in Serum at Baseline and Pre-Surgery
Pre-Surgery
|
151.1 ng/mL
Standard Deviation 25.8
|
136.5 ng/mL
Standard Deviation 72.9
|
SECONDARY outcome
Timeframe: Up to Day 35The 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.
Outcome measures
| Measure |
Arm II (Placebo)
n=8 Participants
Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
Arm I (Cholecalciferol, Genistein)
n=7 Participants
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)
TUNEL Pos (Nucleus)
|
-0.168 Normalized Optical Density
Standard Deviation 0.842
|
0.192 Normalized Optical Density
Standard Deviation 1.122
|
|
Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)
Akt (Cytoplasm)
|
-0.249 Normalized Optical Density
Standard Deviation 0.766
|
0.284 Normalized Optical Density
Standard Deviation 1.142
|
|
Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)
pAkt (Cytoplasm)
|
-0.053 Normalized Optical Density
Standard Deviation 1.004
|
0.061 Normalized Optical Density
Standard Deviation 0.991
|
|
Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)
AR (Nucleus)
|
-0.362 Normalized Optical Density
Standard Deviation 0.294
|
0.414 Normalized Optical Density
Standard Deviation 1.301
|
|
Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)
VDR (Cytoplasm)
|
-0.451 Normalized Optical Density
Standard Deviation 0.410
|
0.515 Normalized Optical Density
Standard Deviation 1.179
|
|
Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)
p21 (Nucleus)
|
-0.085 Normalized Optical Density
Standard Deviation 1.070
|
0.097 Normalized Optical Density
Standard Deviation 0.900
|
|
Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)
PGE2 (Cytoplasm)
|
-0.161 Normalized Optical Density
Standard Deviation 1.023
|
0.184 Normalized Optical Density
Standard Deviation 0.934
|
|
Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)
Caspase 3 (Cytoplasm)
|
-0.308 Normalized Optical Density
Standard Deviation 0.659
|
0.352 Normalized Optical Density
Standard Deviation 1.178
|
|
Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)
PSMA (Cytoplasm)
|
0.025 Normalized Optical Density
Standard Deviation 1.231
|
-0.029 Normalized Optical Density
Standard Deviation 0.630
|
|
Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)
IGF-1 (Cytoplasm)
|
-0.295 Normalized Optical Density
Standard Deviation 0.607
|
0.337 Normalized Optical Density
Standard Deviation 1.220
|
|
Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)
IGF-2 (Cytoplasm)
|
-0.335 Normalized Optical Density
Standard Deviation 0.763
|
0.383 Normalized Optical Density
Standard Deviation 1.081
|
|
Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)
Akt (Nucleus)
|
-0.316 Normalized Optical Density
Standard Deviation 0.618
|
0.361 Normalized Optical Density
Standard Deviation 1.198
|
|
Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)
pAkt (Nucleus)
|
-0.114 Normalized Optical Density
Standard Deviation 0.920
|
0.131 Normalized Optical Density
Standard Deviation 1.068
|
SECONDARY outcome
Timeframe: Up to day Day 35Population: Due to sample in Arm II one participants data was not analyzed.
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.
Outcome measures
| Measure |
Arm II (Placebo)
n=7 Participants
Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
Arm I (Cholecalciferol, Genistein)
n=7 Participants
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)
Akt (Cytoplasm)
|
-0.379 Normalized Optical Density
Standard Deviation 0.785
|
0.379 Normalized Optical Density
Standard Deviation 1.024
|
|
Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)
AR (Nucleus)
|
-0.563 Normalized Optical Density
Standard Deviation 0.481
|
0.563 Normalized Optical Density
Standard Deviation 1.015
|
|
Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)
VDR (Cytoplasm)
|
-0.281 Normalized Optical Density
Standard Deviation 0.657
|
0.281 Normalized Optical Density
Standard Deviation 1.177
|
|
Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)
p21 (Nucleus)
|
-0.185 Normalized Optical Density
Standard Deviation 0.489
|
0.185 Normalized Optical Density
Standard Deviation 1.296
|
|
Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)
PGE2 (Cytoplasm)
|
-0.135 Normalized Optical Density
Standard Deviation 0.969
|
0.135 Normalized Optical Density
Standard Deviation 1.009
|
|
Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)
TUNEL Pos (Nucleus)
|
-0.363 Normalized Optical Density
Standard Deviation 0.664
|
0.363 Normalized Optical Density
Standard Deviation 1.119
|
|
Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)
Caspase 3 (Cytoplasm)
|
-0.103 Normalized Optical Density
Standard Deviation 0.742
|
0.103 Normalized Optical Density
Standard Deviation 1.194
|
|
Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)
PSMA (Cytoplasm)
|
-0.210 Normalized Optical Density
Standard Deviation 0.966
|
0.210 Normalized Optical Density
Standard Deviation 0.982
|
|
Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)
IGF-1 (Cytoplasm)
|
0.155 Normalized Optical Density
Standard Deviation 1.027
|
-0.155 Normalized Optical Density
Standard Deviation 0.943
|
|
Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)
IGF-2 (Cytoplasm)
|
0.443 Normalized Optical Density
Standard Deviation 1.102
|
-0.443 Normalized Optical Density
Standard Deviation 0.572
|
|
Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)
Akt (Nucleus)
|
-0.309 Normalized Optical Density
Standard Deviation 0.903
|
0.309 Normalized Optical Density
Standard Deviation 0.981
|
|
Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)
pAkt (Nucleus)
|
-0.291 Normalized Optical Density
Standard Deviation 0.325
|
0.291 Normalized Optical Density
Standard Deviation 1.302
|
|
Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)
pAkt (Cytoplasm)
|
-0.365 Normalized Optical Density
Standard Deviation 0.377
|
0.365 Normalized Optical Density
Standard Deviation 1.244
|
SECONDARY outcome
Timeframe: up to Day 35Outcome measures
| Measure |
Arm II (Placebo)
n=8 Participants
Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
Arm I (Cholecalciferol, Genistein)
n=7 Participants
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
rs2209314- T/C
|
37.5 percentage of participants
|
42.86 percentage of participants
|
|
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
rs927650- C/T
|
50 percentage of participants
|
14.29 percentage of participants
|
|
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
rs2209314- T/T
|
62.5 percentage of participants
|
57.14 percentage of participants
|
|
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
rs2248359- C/C
|
37.5 percentage of participants
|
42.86 percentage of participants
|
|
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
rs2248359- C/T
|
37.5 percentage of participants
|
57.14 percentage of participants
|
|
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
rs2248359- T/T
|
25 percentage of participants
|
0 percentage of participants
|
|
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
rs2296241- A/A
|
37.5 percentage of participants
|
14.29 percentage of participants
|
|
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
rs2296241- A/G
|
35.5 percentage of participants
|
71.43 percentage of participants
|
|
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
rs2296241- G/G
|
25 percentage of participants
|
14.29 percentage of participants
|
|
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
rs2762939- C/G
|
37.5 percentage of participants
|
28.57 percentage of participants
|
|
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
rs2762939- G/G
|
62.5 percentage of participants
|
71.43 percentage of participants
|
|
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
rs927650- C/C
|
0 percentage of participants
|
71.43 percentage of participants
|
|
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
rs927650- T/T
|
50 percentage of participants
|
14.29 percentage of participants
|
|
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
rs703842- A/A
|
50 percentage of participants
|
14.29 percentage of participants
|
|
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
rs703842- A/G
|
37.5 percentage of participants
|
71.43 percentage of participants
|
|
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
rs703842- G/G
|
12.5 percentage of participants
|
14.29 percentage of participants
|
Adverse Events
Arm II (Placebo)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm I (Cholecalciferol, Genistein)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm II (Placebo)
n=8 participants at risk
Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
Arm I (Cholecalciferol, Genistein)
n=7 participants at risk
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Endocrine disorders
hyperthyriodism
|
12.5%
1/8 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8
|
28.6%
2/7 • Number of events 2
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/8
|
28.6%
2/7 • Number of events 2
|
|
General disorders
fatigue
|
12.5%
1/8 • Number of events 1
|
0.00%
0/7
|
|
General disorders
pain
|
0.00%
0/8
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
sinusitis
|
0.00%
0/8
|
14.3%
1/7 • Number of events 2
|
|
Investigations
blood bilirubin increased
|
12.5%
1/8 • Number of events 1
|
0.00%
0/7
|
|
Investigations
increased serum chloride
|
12.5%
1/8 • Number of events 1
|
0.00%
0/7
|
|
Investigations
platelet count decreased
|
0.00%
0/8
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
hyperglycemia
|
12.5%
1/8 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
12.5%
1/8 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
sinus pain
|
0.00%
0/8
|
14.3%
1/7 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
allergic rhinitis
|
0.00%
0/8
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
calcified lung nodule-right ct scan
|
12.5%
1/8 • Number of events 1
|
0.00%
0/7
|
|
Vascular disorders
hypertension
|
12.5%
1/8 • Number of events 1
|
28.6%
2/7 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60