Enzalutamide + Metformin for Hormone-Resistant Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal dose and examine the side effects of combining enzalutamide, a hormone therapy, with metformin, a common diabetes medication, for treating prostate cancer that resists hormone treatments. Enzalutamide lowers and blocks androgens, helping to combat prostate cancer, while metformin may aid in killing cancer cells. Men with prostate cancer unresponsive to hormone treatments and not currently taking metformin might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to contribute to pioneering cancer research.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking certain medications before enrolling. If you are on non-steroidal anti-androgens or other hormonal treatments, you must stop them at least 28 to 42 days before joining. If you are currently taking metformin, you must have stopped it at least 3 months prior to the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that enzalutamide, a hormone therapy for prostate cancer, is generally well-tolerated by patients. Some studies indicate it can lower certain hormone levels, which helps fight cancer. Common side effects include fatigue and hot flashes, but these are usually manageable.
Metformin, a medication for diabetes, is also under investigation for cancer treatment. Research suggests it might help kill cancer cells when combined with enzalutamide. Metformin is typically safe, with mild side effects like an upset stomach.
Although this trial is in the early stages, both drugs have been used safely in other contexts. This suggests they might be safe when used together, but more research is needed to fully understand the side effects in cancer treatment.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the combination of enzalutamide and metformin for hormone-resistant prostate cancer because it introduces a novel approach to tackling this tough condition. Unlike standard treatments that primarily focus on hormone pathways, this combination leverages metformin's potential to target cancer metabolism alongside enzalutamide's ability to block androgen receptors. This dual mechanism offers a fresh angle on slowing disease progression and potentially overcoming resistance to hormone therapy. By pairing these two drugs, there is hope for improved effectiveness and a new pathway to manage cases that have stopped responding to standard treatments.
What evidence suggests that enzalutamide and metformin hydrochloride could be effective for hormone-resistant prostate cancer?
Research has shown that enzalutamide effectively treats prostate cancer by reducing and blocking androgens, hormones that can promote cancer growth. In this trial, participants will receive a combination of enzalutamide and metformin. Studies have found that metformin can enhance the effectiveness of enzalutamide by affecting how cancer cells produce energy. This combination works well for castration-resistant prostate cancer, a type that doesn't respond to standard hormone treatments. Additionally, metformin helps control several processes in cancer cells involved in tumor growth. These findings suggest that using enzalutamide with metformin may combat more cancer cells in hormone-resistant prostate cancer.16789
Who Is on the Research Team?
Marc Dall'Era, MD
Principal Investigator
University of California, Davis
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive enzalutamide orally once daily and metformin hydrochloride twice daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Enzalutamide
- Metformin Hydrochloride
Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Davis
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Medivation, Inc.
Industry Sponsor
Dr. David Hung
Medivation, Inc.
Chief Executive Officer since 2003
MD from University of California, San Francisco; AB in Biology from Harvard College
Dr. Stephen M. Kelsey
Medivation, Inc.
Chief Medical Officer since 2013
MD from University of Birmingham
Astellas Pharma Inc
Industry Sponsor
Tadaaki Taniguchi
Astellas Pharma Inc
Chief Medical Officer since 2023
MD, PhD
Naoki Okamura
Astellas Pharma Inc
Chief Executive Officer since 2023
University of Tokyo, Faculty of Pharmacy