← Back to Search

Hormone Therapy

Enzalutamide + Metformin for Hormone-Resistant Prostate Cancer

Phase 1

Waitlist Available

Led By Christopher Evans

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Vasectomy or other procedure resulting in infertility (e.g., bilateral orchiectomy), for more than 6 months

Patients must have histologically or cytologically confirmed prostate cancer with a Gleason score available or interpretable

Must not have

Patients with known brain metastases should be excluded from this clinical trial

Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks after last dose of study treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of a diabetes drug, metformin hydrochloride, when given with a hormone therapy drug, enzalutamide, to treat prostate cancer that has not responded to previous hormone therapy.

Who is the study for?

Men with hormone-resistant prostate cancer, who have tried hormone therapy without success, can join this trial. They must have a certain level of health, including normal organ function and blood counts. Participants need to be on or willing to continue castration treatments if applicable and not have had certain prior medications for a specified period. Men must use two forms of birth control with their partners.

What is being tested?

The trial is testing the combination of Enzalutamide (a hormone therapy) and Metformin Hydrochloride (commonly used for diabetes) to see if they work better together in treating prostate cancer that's resistant to hormones. The study will determine the safest doses and observe how well patients respond.

What are the potential side effects?

Possible side effects include those commonly associated with cancer therapies such as fatigue, digestive issues, potential blood sugar changes due to metformin (since it's a diabetes medication), hormonal side effects from enzalutamide like hot flashes or sexual dysfunction, and possibly others depending on individual reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had a procedure like a vasectomy that makes me infertile for over 6 months.

Select...

My prostate cancer has been confirmed with a test, and I know my Gleason score.

Select...

My cancer can't be measured by standard scans, but was checked within the last 28 days.

Select...

I have undergone treatment to lower my testosterone levels and am willing to continue it if needed.

Select...

I stopped taking certain hormone treatments over a month ago and my condition has worsened since.

Select...

My kidney function is normal or nearly normal.

Select...

My female partner has an IUD or IUS in place.

Select...

I am able to get out of my bed or chair and move around.

Select...

My prostate cancer is resistant to hormone therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have brain metastases.

Select...

I am not HIV-positive or not on antiretroviral therapy.

Select...

I haven't had radiotherapy in the last 2 weeks or recovered from its side effects.

Select...

I have a history of seizures or conditions that increase my risk of seizures.

Select...

I am allergic to medications similar to enzalutamide or metformin.

Select...

I have not been in a trial for drugs targeting the androgen receptor.

Select...

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Select...

I am currently taking medication for a psychiatric condition.

Select...

I have received cabazitaxel or radium 223 for prostate cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks after last dose of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks after last dose of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks after last dose of study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Incidence of adverse events graded according to NCI CTCAE version 4.0

PSA progression by Prostate Cancer Working Group (PCWG) 2, defined as the date that a 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later

PSA response rate as determined by percent of patients achieving >= 50% PSA decline following initiation of treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: enzalutamide and metformin hydrochlorideExperimental Treatment2 Interventions

Patients receive enzalutamide PO QD and metformin hydrochloride PO BID. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~3820

Metformin Hydrochloride

2016

Completed Phase 4

~1990