LIpitor and biGuanide to Androgen Delay Trial

NCT ID: NCT02497638

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-31
• Study Completion Date: 2022-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Metformin and Atorvastatin

Atorvastatin 20 mg once daily until progression with one month run-in of 850 mg metformin once daily, followed by 850 mg twice daily of metformin until progression.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

One month run-in of 850 mg metformin once daily, followed by 850 mg twice daily of metformin until progression.

Atorvastatin

Intervention Type: DRUG

Atorvastatin 20 mg once daily until progression.

Placebo

One placebo tablet (corresponding to atorvastatin) once daily until progression, with one month of one placebo tablet (corresponding to metformin) once daily, followed by one placebo tablet twice daily until progression.

Group Type: PLACEBO_COMPARATOR

Placebo (corresponding to metformin)

Intervention Type: DRUG

One month of one placebo tablet (corresponding to metformin) once daily, followed by one placebo tablet twice daily until progression.

Placebo (corresponding to atorvastatin)

Intervention Type: DRUG

One placebo tablet (corresponding to atorvastatin) once daily until progression.

Interventions

Metformin

One month run-in of 850 mg metformin once daily, followed by 850 mg twice daily of metformin until progression.

Intervention Type: DRUG

Atorvastatin

Atorvastatin 20 mg once daily until progression.

Intervention Type: 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.

Intervention Type: DRUG

Placebo (corresponding to atorvastatin)

One placebo tablet (corresponding to atorvastatin) once daily until progression.

Intervention Type: DRUG

Other Intervention Names

biguanide; lipitor

Eligibility Criteria

Inclusion Criteria

• Willing and able to provide informed consent
• Histologically confirmed adenocarcinoma of the prostate
• History of radical therapy (i.e., radical prostatectomy, radiotherapy, brachytherapy or prostatectomy with salvage radiotherapy)
• Serum testosterone levels 8.0 nmol/L (230 ng/dL) or greater
• Not currently undergoing treatment for hyperlipidemia or diabetes mellitus
• LDL-cholesterol levels 5 mmol/L or lower
• HgA1c 6.5% or lower
• PSA levels between 2 and 5 ng/mL

Exclusion Criteria

• Subjects that have been treated for prostate cancer with any of the following:

i. Cytotoxic chemotherapy; ii. Hormonal therapy within past 3 years; iii. Oral glucocorticoids; iv. Gonadotropin-releasing hormone (GnRH) analogues (e.g., leuprolide, goserelin, degarelix)

• Past treatment with the 5-α reductase inhibitors finasteride and dutasteride within past 5 years
• Past treatment with drugs with antiandrogenic properties (e.g., flutamide, bicalutamide, ketoconazole, progestational agents) within 6 months prior to screening
• Use of metformin or statins within past 2 years
• Planned or concurrent use of metformin, sulfonylureas, thiazolidinediones or insulin for any reason
• Known hypersensitivity or intolerance to metformin or atorvastatin
• Any clinically significant laboratory abnormalities (e.g., severe renal or hepatic impairment) which in the judgment of the investigator would affect the patient's health or the outcome of the trial
• Any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as New York Heart Association (NYHA) class III or IV, history of any type of acidosis, habitual intake of 4 or more alcoholic beverages per day)
• Abnormal liver function test
• Abnormal organ and marrow function

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Hamilton, MD, MPH, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Neil Fleshner, MD, MPH, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

15-053

Identifier Type: -

Identifier Source: org_study_id