CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
metformin hydrochloride +2 moredrug
Likely dose
Metformin hydrochloride orally (specific dose not stated)AI-extracted
Key inclusion· 4
  • ✓Histologically confirmed organ-confined adenocarcinoma of the prostate treatable by prostatectomy
  • ✓PSA less than 50 ng/mL
  • ✓ECOG performance status 0-1 (Karnofsky ≥70%)
  • ✓No prior chemotherapy and/or radiation for any malignancy in past 5 years (excluding non-melanoma skin cancer and cancers with removal as only treatment)
Key exclusion· 10
  • ✕Type I or type II diabetic patients on treatment with any drug for diabetes or fasting glucose ≥126 mg/dL
  • ✕History of impaired liver or kidney function
  • ✕Current history of high alcohol consumption (>3 standard drinks/day) or binge drinking (5+ drinks in 1-3 hours)
  • ✕History of lactic acidosis or at increased risk (unstable/acute CHF with risk of hypoperfusion/hypoxemia)

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

Search/NCT01433913
NCT01433913Phase 2Completed
CompareCT.gov

Phase II Study of Metformin in a Pre-prostatectomy Prostate Cancer Cohort

National Cancer Institute (NCI)·interventional·Posted Sep 14, 2011·Updated Jan 10, 2018

In Brief

A Phase 2 clinical trial evaluating metformin hydrochloride, placebo, and 1 other intervention for Adenocarcinoma of the Prostate and 4 related conditions. Completed, enrolled 20 participants across 3 sites.

Detailed Summary

This randomized phase II trial studies how well metformin hydrochloride works compared to placebo in treating patients with prostate cancer undergoing surgery. Metformin hydrochloride may make some enzymes active. These enzymes may block other enzymes needed for cell growth and stop the growth of tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 14, 2011
Enrollment StartNov 1, 2011
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 14.8 years ago

Interventions

metformin hydrochloridedrug

Given PO

placeboother

Given PO

laboratory biomarker analysisother

Correlative studies