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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
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 belowSelect...
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.
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My female partner has an IUD or IUS in place.
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I am able to get out of my bed or chair and move around.
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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.
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I am not HIV-positive or not on antiretroviral therapy.
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I haven't had radiotherapy in the last 2 weeks or recovered from its side effects.
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I have a history of seizures or conditions that increase my risk of seizures.
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I am allergic to medications similar to enzalutamide or metformin.
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I have not been in a trial for drugs targeting the androgen receptor.
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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.
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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
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
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
~2970
Metformin Hydrochloride
2016
Completed Phase 4
~1990
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
928 Previous Clinical Trials
4,720,994 Total Patients Enrolled
13 Trials studying Prostate Cancer
1,805 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,976 Total Patients Enrolled
566 Trials studying Prostate Cancer
529,785 Patients Enrolled for Prostate Cancer
Medivation, Inc.Industry Sponsor
75 Previous Clinical Trials
11,218 Total Patients Enrolled
11 Trials studying Prostate Cancer
644 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have brain metastases.I am not HIV-positive or not on antiretroviral therapy.I haven't had radiotherapy in the last 2 weeks or recovered from its side effects.I have had a procedure like a vasectomy that makes me infertile for over 6 months.I have received cabazitaxel or radium 223 for prostate cancer.My cancer can't be measured by standard scans, but was checked within the last 28 days.I am currently taking medication for a psychiatric condition.My prostate cancer has been confirmed with a test, and I know my Gleason score.My cancer has progressed recently, as confirmed by tests.My PSA levels have been rising consistently over time.My tumor size was recently measured by scans or X-rays.I have undergone treatment to lower my testosterone levels and am willing to continue it if needed.I stopped taking certain hormone treatments over a month ago and my condition has worsened since.My kidney function is normal or nearly normal.I am a male and will use a condom and another birth control method with my partner.My female partner has an IUD or IUS in place.I have diabetes and am not on insulin, or I have rheumatoid arthritis and take Plaquenil.I have a history of seizures or conditions that increase my risk of seizures.I am currently taking metformin or stopped it at least 3 months ago.I have a tumor that wasn't treated with radiation in the last 2 months, or it has grown after radiation.I am allergic to medications similar to enzalutamide or metformin.I have not been in a trial for drugs targeting the androgen receptor.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.My partner and I use a barrier method with spermicide for contraception.I can swallow pills and follow the study's rules.You are not allowed to be taking any other experimental medications.I am taking medication to prevent bone problems or treat osteoporosis.I am able to get out of my bed or chair and move around.My cancer has grown recently, as confirmed by tests within the last 28 days.I have had more than 2 treatments for prostate cancer after it spread, including docetaxel or abiraterone before chemotherapy.My prostate cancer is resistant to hormone therapy.
Research Study Groups:
This trial has the following groups:- Group 1: enzalutamide and metformin hydrochloride
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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