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NCT01325311 · ClinicalTrials.gov registry record · Phase 2

Cholecalciferol and Genistein Before Surgery in Treating Patients With Early Stage Prostate Cancer

A Phase 2 study of Prostate Adenocarcinoma and Stage I Prostate Cancer, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
15
Enrollment target
11
Study locations

NCT01325311 is a Phase 2 study of Prostate Adenocarcinoma and Stage I Prostate Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 15 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (93% lower). The trial reports 11 study locations across 9 states.

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The verdict

NCT01325311, a Phase 2 study of Prostate Adenocarcinoma and Stage I Prostate Cancer, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
15 participants
Enrollment target
11
Study locations

Study 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.

Interventions

  • OTHER Placebo
  • OTHER Laboratory Biomarker Analysis
  • OTHER Pharmacological Study
  • DRUG Cholecalciferol
  • DRUG Genistein

Study Locations (11)

Maryland

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital - Baltimore
  • Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore

Minnesota

  • Minneapolis Veterans Medical Center - Minneapolis
  • University of Minnesota Medical Center-Fairview - Minneapolis

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

Massachusetts

  • Lahey Hospital and Medical Center - Burlington

New York

  • University of Rochester - Rochester

Oklahoma

  • University of Oklahoma Health Sciences Center - Oklahoma City

South Carolina

  • Carolina Urologic Research Center - Myrtle Beach

Texas

  • Urology San Antonio Research PA - San Antonio

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2011-12
Est. Completion 2014-07
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01325311

The ClinicalTrials.gov registry entry for NCT01325311 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (93% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.

NCT01325311 reports 11 study locations spanning 9 distinct geographic areas - top geographies include Maryland, Minnesota, Alabama.

Frequently Asked Questions

What is clinical trial NCT01325311 about?

NCT01325311 is a clinical study titled "Cholecalciferol and Genistein Before Surgery in Treating Patients With Early Stage Prostate Cancer". 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.

What is the current status of trial NCT01325311?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2011-12. Estimated completion is 2014-07.

What conditions does trial NCT01325311 study?

This clinical trial studies the following conditions: Prostate Adenocarcinoma, Stage I Prostate Cancer, Stage IIB Prostate Cancer, Stage IIA Prostate Cancer.

What interventions are being tested in trial NCT01325311?

The interventions under investigation include: Placebo (OTHER), Laboratory Biomarker Analysis (OTHER), Pharmacological Study (OTHER), Cholecalciferol (DRUG), Genistein (DRUG).

Who is sponsoring clinical trial NCT01325311?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01325311 being conducted?

This trial has 11 study locations across Alabama, Maryland, Massachusetts, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.