Project

SAKK 08/14 Investigation of Metformin in patients with castration resistant Prostate Cancer in combination with Enzalu-tamide vs. Enzalutamide alone (IMPROVE TRIAL)

Ongoing - recruitment closed · 2016 until 2026

Type
Clinical Studies
Range
Multicentric, KSSG as main centre
Units
Status
Ongoing - recruitment closed
Start Date
2016
End Date
2026
Financing
SAKK
Study Design
Phase II
Brief description/objective

The current standard of care for patients with metastatic castration resistant prostate cancer (mCRPC) and dis-ease progression is either treatment with abiraterone acetate and prednisone in asymptomatic or mildly symp-tomatic patients without visceral metastases, treatment with enzalutamide or treatment with docetaxel in more symptomatic patients and in the presence of visceral metastases.
Rothemundt et al. previously demonstrated favorable effects of metformin in a phase II trial: it yields objective PSA responses and may induce disease stabilization and improve metabolic endpoints in patients with CRPC. Therefore addition of metformin to enzalutamide might have positive impact on tumor progression, on body composition, and insulin sensitivity.