Cholecalciferol and Genistein Before Surgery in Treating Patients With Early Stage Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01325311
First received: March 23, 2011
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma of the Prostate Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer |
Drug: cholecalciferol Dietary Supplement: genistein Other: placebo Other: laboratory biomarker analysis Other: pharmacological study |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase IIA, Randomized Placebo-Controlled Trial of Single High Dose Cholecalciferol and Daily Genistein (G-2535) Versus Placebo in Men With Early Stage Prostate Cancer Undergoing Prostatectomy |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Tissue levels of calcitriol between the placebo and cholecalciferol/genistein arms [ Time Frame: Up to 35 days ] [ Designated as safety issue: No ]Using the Student t-test. Wilcoxon rank-sum test will be used for comparison.
Secondary Outcome Measures:
- Levels of calcitriol on down-stream related biomarkers and related mechanistic pathways in blood and tissue [ Time Frame: At baseline ] [ Designated as safety issue: No ]Summarized by treatment arm with descriptive statistics.
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2012 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Drug: cholecalciferol
Given PO
Other Names:
Dietary Supplement: genistein
Given PO
Other Names:
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
|
Placebo Comparator: 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.
|
Other: placebo
Given PO
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine differences in prostate tissue steady state concentrations of calcitriol in participants treated with a single dose cholecalciferol (200,000 IU) and G-2535 (which provides 600 mg of genistein) and those receiving placebo.
SECONDARY OBJECTIVES:
I. To determine the effect of each intervention arm and resulting prostate tissue levels of calcitriol on down-stream related biomarkers and related mechanistic pathways in blood and tissue.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive cholecalciferol orally (PO) on day 1 and genistein PO once daily (QD) on days 1-21 or 1-28. Patients then undergo prostatectomy.
ARM II: Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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 ECOG performance status =<1 (Karnofsky >= 70%)
- WBC within normal limits
- Platelets >= 100 K/uL
- Hemoglobin >= 10 g/dL
- TSH =< 4.20 uIU/mL
- Free T4 =< 12.5 ng/dL
- Bilirubin within upper limit of normal
- Aspartate aminotransferase (AST) =< 1.5 x upper limit of normal
- Creatinine =< 2.0 mg/dL
- Serum calcium: within institutional normal limits
- Participants must agree to stop taking NSAIDS during the course of the study, however, low dose aspirin (< 100 mg/day) will be allowed; no wash out period is required
- Participants must be willing to discontinue consuming soy products and ingesting vitamin supplements while participating in this study
- The effects of cholecalciferol and genistein on the developing human fetus at the recommended therapeutic doses are unknown; for this reason, participants must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation
- Participants must have the ability to understand and sign a consent form indicating the investigational nature of the treatment and its potential risks
Exclusion Criteria:
- Participants may not have received any prior therapy for prostate cancer including: chemotherapy, hormonal therapy, brachytherapy, or external radiation
- Participants may not be receiving concurrent systemic therapy for other cancers
- Participants may not be receiving any other investigational agents
- Participants may not be taking the following p450 inducers and inhibitors: carbamazepine, clarithromycin, fluconazole, fosphenytoin, itraconazole, ketoconazole, phenobarbital, phenytoin, rifabutin, rifampin
- Participants took finasteride or dutasteride within 6 months of the pre-randomization biopsy, are currently taking finasteride or dutasteride, or are planning on taking these agents during study participation
- Participants with a history of allergic reactions attributed to genistein or placebo, or compounds of similar chemical or biologic composition
- Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Participants with a history of thyroid disease, nephrolithiasis and/or sarcoidosis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325311
Locations
| United States, Wisconsin | |
| University of Wisconsin Chemoprevention Consortium | |
| Madison, Wisconsin, United States, 53706-1969 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Howard Bailey | University of Wisconsin Chemoprevention Consortium |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01325311 History of Changes |
| Other Study ID Numbers: | NCI-2013-00451, UWI09-14-01, CDR0000698228, N01CN35153 |
| Study First Received: | March 23, 2011 |
| Last Updated: | May 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases Cholecalciferol Genistein |
Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents Phytoestrogens Estrogens, Non-Steroidal Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anticarcinogenic Agents Protective Agents Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013