drugset / Trial / NCT01433913
Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2011-11
- Primary completion
- 2014-04
- Completion
- 2014-04
Outcome
Missed primary endpoint
registry Arm I (Metformin Hydrochloride) vs Arm II (Placebo); p = 0.23; Wilcoxon (Mann-Whitney) NCT01433913 ↗
Publications
- Roy S, Malone S, Grimes S, Morgan SC. Impact of Concomitant Medications on Biochemical Outcome in Localised Prostate Cancer Treated with Radiotherapy and Androgen Deprivation Therapy. Clin Oncol (R Coll Radiol). 2021 Mar;33(3):181-190. doi: 10.1016/j.clon.2020.09.005. Epub 2020 Sep 29.
- Nguyen MM, Martinez JA, Hsu CH, Sokoloff M, Krouse RS, Gibson BA, Nagle RB, Parnes HL, Cordova C, Chow HS. Bioactivity and prostate tissue distribution of metformin in a preprostatectomy prostate cancer cohort. Eur J Cancer Prev. 2018 Nov;27(6):557-562. doi: 10.1097/CEJ.0000000000000394.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | — | Oral |