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Enzalutamide + Metformin for Hormone-Resistant Prostate Cancer
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: enzalutamide and metformin hydrochloride
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Are there any other investigations into the efficacy of Metformin Hydrochloride?
"Presently, 265 Metformin Hydrochloride related trials are in progress. 72 of these studies have advanced to the third clinical trial phase and are being conducted primarily in Germantown, Tennessee with a total of 7506 locations offering this medication as part of their research efforts."
Has Metformin Hydrochloride achieved governmental sanction?
"Due to the private nature of this first phase medical trial, Metformin Hydrochloride's safety rating is estimated at 1 on a scale from 1-3. This is based on limited data that suggests its therapeutic capabilities and safety profile."
What medical ailments does Metformin Hydrochloride typically target?
"Metformin Hydrochloride is a well-known medication for treating castration. Additionally, it can be very effective in managing type 1 diabetes mellitus and diabetic ketoacidosis as well as facilitating physical exercise."
To what extent is enrollment for this experiment open to participants?
"Unfortunately, this clinical trial is not accepting patients anymore. It was first posted on June 22nd 2016 and its most recent update took place on October 4th 2022. However, 1321 studies related to prostate cancer are recruiting participants as well as 265 trials for Metformin Hydrochloride."
Are any additional volunteers needed for this experiment?
"At this time, no new participants are being sought for the trial. The study was initially made public on June 22nd 2016 and its information has been refreshed as recently as October 4th 2022. If you're interested in alternative studies, there are currently over 1300 clinical trials looking to enroll people with prostate cancer and 265 research initiatives searching for participants taking Metformin Hydrochloride."
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