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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: Completed Phase 2 study of Prostate Adenocarcinoma and Stage I Prostate Cancer, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This is a measure of calcitriol in prostate tissue comparing placebo and cholecalciferol/genistein
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT01325311 record still lists
NCT01325311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (93% lower).
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 lists 11 locations in 9 states (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.
Learn More About Clinical Trials
Similar trials for Prostate Adenocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01325311's enrollment target sits among peer trials
15 91st of 99 higher than 9 of 99 other Prostate Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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