At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 15 enrolled
Drug / intervention
Cholecalciferol +4 moredrug
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.
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
In Brief
A Phase 2 clinical trial evaluating Cholecalciferol, Genistein, and 3 other interventions for Prostate Adenocarcinoma and 3 related conditions. Completed, enrolled 15 participants across 11 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Adenocarcinoma, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2011
Enrollment StartDec 2011
Primary CompletionJul 2014
TodayJul 2026
First PostedMar 29, 2011
Enrollment StartDec 1, 2011
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.3 years ago
Interventions
Cholecalciferoldrug
Given PO
Genisteindrug
Given PO
Laboratory Biomarker Analysisother
Correlative studies
Pharmacological Studyother
Correlative studies
Placeboother
Given PO