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LIpitor and biGuanide to Androgen Delay Trial

NCT02497638 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-04-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Robert Hamilton, MD, MPH, FRCSC · University Health Network, Toronto

  • Neil Fleshner, MD, MPH, FRCSC · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02497638 on ClinicalTrials.gov