Phase 2 Completed N=20 Randomized Double-blind Treatment

Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

Prostate Cancer · Recurrent Prostate Cancer · Stage I Prostate Cancer · Stage IIA Prostate Cancer

Source: ClinicalTrials.gov NCT01433913 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

May 2015

Primary outcomePrimary: Cell Proliferation in the Prostatectomy Tissue as Assessed by Ki67 Expression Using Immunohistochemistry (IHC) — 6.5; 3.67 % positively stained nuclei — p=0.23

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Cell Proliferation in the Prostatectomy Tissue as Assessed by Ki67 Expression Using Immunohistochemistry (IHC)	6.5; 3.67	0.23
SECONDARY Prostate Tissue Metformin Concentration Levels as Assessed by Liquid Chromatography Tandem Mass Spectrometry	5.71; 0	<0.01 sig
SECONDARY Apoptosis Levels in the Prostatectomy Tissue as Assessed by IHC of Cleaved Caspase 3	0.07; 0.1	0.77
SECONDARY Cell Cycle Regulation in the Prostatectomy Tissue as Assessed by IHC of Cyclin D1	37.5; 13.3	0.09
SECONDARY mTOR Regulation in the Prostatectomy Tissue as Assessed by IHC of Phospho-p70 S6 Kinase (p-p70S6K)	66.7; 63.3	0.72
SECONDARY Angiogenesis in the Prostatectomy Tissue as Assessed by IHC of CD34	—	—
SECONDARY AMPK Activation in the Prostatectomy Tissue as Assessed by IHC of p-AMPK	—	—
SECONDARY Cell Cycle Regulation in the Prostatectomy Tissue as Assessed by IHC of Retinoblastoma Protein Phosphorylation (p-pRb)	—	—
SECONDARY Changes in Serum PSA	-6.53; 5.98	0.63
SECONDARY Changes in Serum Fasting Insulin	-11.42; 5.66	0.25
SECONDARY Changes in Serum IGF-1/IGFBP-3	7.07; -2.24	0.46
SECONDARY Changes in Serum Testosterone	-16.12; 2.04	0.46
SECONDARY Changes in Serum SHBG	0.48; -6.49	0.36
SECONDARY Changes in Serum Fasting Glucose	—	—

Eligibility Criteria

Inclusion Criteria

Men will be eligible to this study if they are diagnosed with a histologically confirmed organ-confined adenocarcinoma of the prostate (PCa) treatable by prostatectomy and have a current PSA less than 50 ng/ml
Have not received chemotherapy and/or radiation for any malignancy (excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment) in the past 5 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky >= 70%)
Leukocytes >= 3,000/uL
Absolute neutrophil count >= 1,500/uL
Platelets >= 100,000/uL
Total bilirubin = = 126 mg/dL
History of impaired liver or kidney function
Participants with a current history of high alcohol consumption (> 3 standard drinks/day) or binge drinking (5 or more drinks) in one session of 1-3 hours
History of lactic acidosis or at increased risk for lactic acidosis such as patients with unstable or acute congestive heart failure who are at risk of hypoperfusion with hypoxemia
Participants may not be receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical composition to metformin
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
History of acute or chronic metabolic acidosis
Concurrent use of cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin)
Concurrent use of non-study metformin or other biguanides

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01433913). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.