NCT02497638

LIpitor and biGuanide to Androgen Delay Trial

A Randomized, Double Blind, Trial of Metformin and Atorvastatin in Delaying Androgen Deprivation Therapy Among Men With Rising PSA Following Radical Prostatectomy or Radiotherapy: The LIGAND (LIpitor and biGuanide to Androgen Delay) Trial

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized trial examining the administration of a combination of biguanide metformin and atorvastatin ("Lipitor") to men who are experiencing rising prostate-specific antigen (PSA) levels, despite having undergone radical therapy (surgery and/or radiation).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Metformin	One month run-in of 850 mg metformin once daily, followed by 850 mg twice daily of metformin until progression.
DRUG	Atorvastatin	Atorvastatin 20 mg once daily until progression.
DRUG	Placebo (corresponding to metformin)	One month of one placebo tablet (corresponding to metformin) once daily, followed by one placebo tablet twice daily until progression.
DRUG	Placebo (corresponding to atorvastatin)	One placebo tablet (corresponding to atorvastatin) once daily until progression.

Timeline

• Start date: 2021-12-01
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2015-07-14
• Last updated: 2021-04-19

Locations

1 site across 1 country: Canada