CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Vitamin D +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00499408
NCT00499408Phase 2Completed
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Phase II Trial of Vitamin D and Soy Supplementation for Biochemically Recurrent Prostate Cancer Following Definitive Local Therapy

Wake Forest University Health Sciences·interventional·Posted Jul 11, 2007·Updated Nov 21, 2018

In Brief

A Phase 2 clinical trial evaluating Vitamin D and soy for Prostate Cancer. Completed, enrolled 26 participants across 1 site.

Detailed Summary

RATIONALE: Vitamin D and soy extract may be effective in lowering prostate-specific antigen (PSA) levels in patients with recurrent prostate cancer that has not responded to previous treatment. PURPOSE: This phase II trial is studying how well giving vitamin D together with soy supplements works in treating patients with recurrent prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 11, 2007
Enrollment StartApr 1, 2007
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 19.0 years ago

Interventions

Vitamin Ddietary

Patients will receive oral supplementation of 2,000 IU per day of vitamin D (cholecalciferol)

soydietary

Patients will receive oral supplementation of soy (160 mg per day soy isoflavones).