CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Digoxindrug
Likely dose
Digoxin 250 mcgfrom 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/NCT01162135
NCT01162135Phase 2Completed
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A Pilot Phase II Study of Digoxin in Patients With Recurrent Prostate Cancer as Evident by a Rising PSA

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·interventional·Posted Jul 14, 2010·Updated May 4, 2025

In Brief

A Phase 2 clinical trial evaluating Digoxin for Prostate Cancer. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the effectiveness of dioxin on prohibiting prostate cancer progression as measured by PSADT (prostate-specific antigen doubling time).

Study Details

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

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 14, 2010
Enrollment StartSep 1, 2010
Primary CompletionMar 1, 2013
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.0 years ago

Interventions

Digoxindrug

The participants will take study drug digoxin, which is approved by FDA for the treatment of CHF, 125 or 250 mcg orally daily, titrated to the level of 0.8 - 2 ng/ml for total of 6 cycles (4 weeks/cycle). The lower dose of digoxin (such as 125 mcg/day) will be chosen if serum level reaches 0.8 ng/ml already. Patients may continue another 6 cycles if evident of clinical benefit. It is possible that some patients may need to receive 500 mcg per day to reach this targeted drug level. No further titration will be allowed beyond this FDA approved digoxin dose.