CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
Observation and Bicalutamide +1 moredrug
Likely dose
Observation and Bicalutamide 50 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/NCT02614859
NCT02614859Phase 2Completed
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Bicalutamide With or Without Metformin for Biochemical Recurrence in Overweight or Obese Prostate Cancer Patients (BIMET-1)

Fox Chase Cancer Center·interventional·Posted Nov 25, 2015·Updated Mar 29, 2022

In Brief

A Phase 2 clinical trial evaluating Observation and Bicalutamide and Metformin and Bicalutamide for Cancer of Prostate. Completed, enrolled 29 participants across 2 sites.

Detailed Summary

Obesity and metabolic syndrome are prevalent among prostate cancer patients. Having an elevated insulin level in the blood is associated with a shorter median time to cancer progression and median overall survival in patients with an elevated PSA after prior treatment. Androgen deprivation therapy (ADT) with drugs like bicalutamide is frequently used in this patient population,with no proven benefit, which may increase mortality and morbidity.This study evaluates how metformin in combination with bicalutamide affects prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer of Prostate
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 25, 2015
Enrollment StartDec 1, 2015
Primary CompletionJan 24, 2020
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 10.6 years ago

Interventions

Observation and Bicalutamidedrug

Cycles 1 - 2: Observation without treatment Cycles 3 - 8: Bicalutamide 50 mg daily, orally, continuously to the end of study (week 32).

Metformin and Bicalutamidedrug

Cycles 1-2: Metformin 1000mg BID Cycles 3-8: Bicalutamide 50 mg daily and Metformin 1000 mg BID