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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

Phase 2
18 Years
Open (Enrolling)
Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

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Trial Information

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


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.


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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Tissue levels of calcitriol between the placebo and cholecalciferol/genistein arms

Outcome Description:

Using the Student t-test. Wilcoxon rank-sum test will be used for comparison.

Outcome Time Frame:

Up to 35 days

Safety Issue:


Principal Investigator

Howard Bailey

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin Chemoprevention Consortium


United States: Food and Drug Administration

Study ID:




Start Date:

June 2012

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Stage I Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



University of Wisconsin Chemoprevention ConsortiumMadison, Wisconsin  53706-1969