CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 73 enrolled
Drug / intervention
lovastatindrug
Likely dose
lovastatin 20 mgfrom 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/NCT00580970
NCT00580970Phase 2Completed

A Phase II Study to Prevent Radiation-Induced Rectal Injury With Lovastatin

Virginia Commonwealth University·interventional·Posted Dec 27, 2007·Updated Nov 18, 2016

In Brief

A Phase 2 clinical trial evaluating lovastatin for Prostate Cancer. Completed, enrolled 73 participants across 3 sites.

Detailed Summary

Lovastatin may protect against late effects of radiation therapy in patients with prostate cancer

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 27, 2007
Enrollment StartApr 1, 2007
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 18.5 years ago

Interventions

lovastatindrug

The HMG-coA reductase inhibitor used in this study will be lovastatin. Dosage: 20 mg/d PO with evening meal. Patients on a higher dose of lovastatin at the time of study entry may continue at that dose level; for patients switching to lovastatin, the dose will be at the discretion of the prescribing physician, but must be at least 20 mg/day.Schedule: begin on the first day of external beam radiation therapy (external beam alone or external beam followed by brachytherapy) or on the day of brachytherapy (brachytherapy alone or brachytherapy followed by external beam radiotherapy) and continue for 12 months. Patients or their third party payers will be expected to cover the cost of the drug.