Combination Therapy for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of treatments to determine the best management for intermediate or high-risk prostate cancer. It examines how enzalutamide (a medication that reduces male hormones fueling cancer growth), radiation therapy, and hormone therapy (including goserelin acetate and leuprolide acetate) work together and their potential side effects. Men with prostate cancer who have specific indicators, such as a high Gleason score (a measure of cancer aggressiveness) or elevated PSA levels (a protein produced by prostate cells), and who haven't undergone certain surgeries or had other cancers, might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.
Do I need to stop my current medications for the trial?
You may need to stop taking certain medications if they are CYP2C8 or CYP3A4 inhibitors or inducers, like gemfibrozil or rifampin. The trial does not specify other medication restrictions, so it's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that enzalutamide, one of the drugs in this trial, is generally well-tolerated. In one study, men taking enzalutamide had a 61% lower risk of prostate cancer progression compared to those not taking the drug. When combined with leuprolide, it reduced the risk of death by 40% compared to using leuprolide alone.
Studies have demonstrated that the hormone therapies goserelin acetate and leuprolide acetate are effective and generally well-tolerated. Goserelin safely lowers male hormone levels to very low levels in patients. Similarly, leuprolide is widely used and considered safe for treating prostate cancer by reducing male hormone levels.
Radiation therapy, also part of the treatment plan, has been found to be safe and effective. Some studies indicate that different types of radiation therapy have similar safety outcomes. Minor risks of urinary problems may occur, but these are usually manageable.
As this is an early trial, the main goal is to determine the best way to use these treatments together. Safety data from earlier studies guide this process, but it is important to remember that this trial is still exploring the safety of this specific combination.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this combination therapy for prostate cancer because it integrates enzalutamide, a novel androgen receptor inhibitor, with traditional hormone therapy and radiation. Unlike standard treatments like surgery or hormone therapy alone, this approach targets the cancer from multiple angles, potentially enhancing effectiveness. Enzalutamide blocks the effects of androgens on the prostate cancer cells, while the LHRH agonists (goserelin acetate or leuprolide acetate) and radiation therapy work to further reduce tumor growth and spread. This multi-pronged attack could lead to better outcomes for patients, especially those with high-risk prostate cancer.
What evidence suggests that this combination therapy might be an effective treatment for prostate cancer?
In this trial, participants will receive a combination of treatments, including enzalutamide, radiation therapy, and hormone therapy with either goserelin acetate or leuprolide acetate. Studies have shown that enzalutamide, when combined with other treatments, significantly improves survival and slows tumor growth in prostate cancer patients. One study found that 50% of patients taking enzalutamide were still alive after 96 months, compared to 40% in another treatment group. Additionally, combining enzalutamide with leuprolide increased survival more than using leuprolide alone. Both goserelin acetate and leuprolide acetate effectively lower androgen levels, helping to slow cancer growth. Radiation therapy, including methods like SBRT and IMRT, has shown promising results in controlling prostate cancer, with high survival rates and low recurrence. Together, these treatments provide a comprehensive approach to managing prostate cancer.13678
Who Is on the Research Team?
Robert B. Den
Principal Investigator
Thomas Jefferson University
Are You a Good Fit for This Trial?
Men over 18 with intermediate or high-risk prostate cancer that hasn't spread far (no distant metastases), a Gleason score ≥7, PSA ≥10 ng/ml, or T2b+ disease. They must have good organ function and blood counts, be able to use contraception, and not have had certain treatments or conditions that could complicate the trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive enzalutamide orally once daily for 6 months. LHRH agonist therapy begins 2 weeks after enzalutamide and continues for 6 months (intermediate risk) or 24 months (high risk) post-radiation. Radiation therapy begins 8 weeks after LHRH therapy start and continues for 8 weeks.
Radiation
Participants undergo either intensity modulated radiation therapy (IMRT) or volumetric arc therapy (VMAT) daily five days a week for 8 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion every 3 months for 2 years, every 6 months for 2 years, and then annually.
What Are the Treatments Tested in This Trial?
Interventions
- Enzalutamide
- Goserelin acetate
- Leuprolide acetate
- Radiation Therapy
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?
Thomas Jefferson University
Lead Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Lead Sponsor
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
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