Phase 2
Completed N=15
Cholecalciferol and Genistein Before Surgery in Treating Patients With Early Stage Prostate Cancer
Prostate adenocarcinoma · Stage I Prostate Cancer · Stage IIA Prostate Cancer · Stage IIB Prostate Cancer
Source: ClinicalTrials.gov NCT01325311 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcomePrimary: Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms — 0.045; 0.057 ng/mL — p=0.922
Summary
This randomized phase II trial studies cholecalciferol and genistein compared to placebo in treating patients with early stage prostate cancer. Cholecalciferol and genistein may slow the growth of cancer cells and may be an effective treatment for prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms |
0.045; 0.057 | 0.922 |
| PRIMARY Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms |
7; 6; 1; 1 | — |
| SECONDARY Levels of Calcidiol in the Participants Serum |
20.5; 24.5; 19.2; 27.3 | — |
| SECONDARY Levels of Calcitriol in Participants Serum |
0.5; 0.5; 0.5; 0.1 | — |
| SECONDARY PBMC CYP mRNA Expression of CYP24 |
3.054; 2.202 | — |
| SECONDARY PBMC CYP mRNA Expression of CYP27B1 |
1.656; 2.389 | — |
| SECONDARY Total PSA in Serum |
8.7; 6.3; 8.3; 5.8 | — |
| SECONDARY Serum Calcium Levels at Baseline and Pre-Surgery |
10.5; 11.3; 10.8; 10.9 | — |
| SECONDARY Total IGF-1 in Serum at Baseline and Pre-Surgery |
64.2; 66.3; 60.6; 74.6 | — |
| SECONDARY Total IGF-2 in Serum at Baseline and Pre-Surgery |
770.4; 805.9; 605.0; 858.8 | — |
| SECONDARY Total IGFBP-3 in Serum at Baseline and Pre-Surgery |
1838.9; 2004.5; 1667.5; 1843.4 | — |
| SECONDARY Total PTH in Serum at Baseline and Pre-Surgery |
143.4; 144.8; 151.1; 136.5 | — |
| SECONDARY Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) |
-0.362; 0.414; -0.451; 0.515; -0.085; 0.097 | — |
| SECONDARY Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) |
-0.563; 0.563; -0.281; 0.281; -0.185; 0.185 | — |
| SECONDARY Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) |
37.5; 42.86; 62.5; 57.14; 37.5; 42.86 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must have microscopic confirmation of adenocarcinoma of the prostate within three months of randomization; clinical stage T1 and T2 a, b, or c are allowed
- Participants' prostate cancer must be confined to the prostate (in the clinical judgment of the treating physician)
- Participants must be candidates for prostatectomy
- Participants must have Eastern Cooperative Oncology Group (ECOG) performance status = = 70%)
- White blood cell (WBC) within normal limits
- Platelets >= 100 K/uL
- Hemoglobin >= 10 g/dL
- Thyroid-stimulating hormone (TSH) = 5 years ago, with current normal thyroid function, will be considered eligible
- Participant has current, known nephrolithiasis or a history of nephrolithiasis within the past 5 years
- Participant has any history of sarcoidosis
Data sourced from ClinicalTrials.gov (NCT01325311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.