Enzalutamide for Prostate Cancer
(PROSPER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests enzalutamide, a medication for non-metastatic prostate cancer. Researchers aim to assess its safety and effectiveness when combined with ongoing hormone therapy. Participants should have prostate cancer that hasn't spread, be on hormone therapy, and still experience cancer progression. Those who have not received other treatments like chemotherapy for prostate cancer and are not experiencing symptoms may be suitable candidates. The study involves two groups: one taking enzalutamide and another taking a placebo pill that looks identical. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial requires ongoing androgen deprivation therapy, but it does not specify if you need to stop other medications. It's best to discuss your current medications with the trial team to be sure.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that enzalutamide is generally well-tolerated by patients with prostate cancer. Studies have found that it significantly improves survival rates and slows cancer progression. In one study with 2,275 patients, those taking enzalutamide had a 33% lower risk of death compared to those who did not take it.
While enzalutamide is effective, knowing about possible side effects is important. Some patients have experienced tiredness, hot flashes, and high blood pressure. However, these side effects are usually manageable and do not outweigh the benefits for most patients.
The FDA has already approved enzalutamide for treating other stages of prostate cancer, indicating a well-established safety record. Considering joining a trial? Discuss potential risks and benefits with your doctor.12345Why do researchers think this study treatment might be promising for prostate cancer?
Enzalutamide is unique because it targets prostate cancer by blocking androgen receptors more effectively than many standard treatments. Unlike traditional hormone therapies, which generally reduce the overall levels of androgens, enzalutamide directly prevents these hormones from binding to their receptors, halting cancer cell growth at the source. Researchers are particularly excited about enzalutamide because it may offer improved efficacy in delaying disease progression, potentially leading to better outcomes for patients with advanced prostate cancer.
What evidence suggests that enzalutamide might be an effective treatment for prostate cancer?
Research has shown that enzalutamide, which participants in this trial may receive, effectively treats prostate cancer. One study showed that enzalutamide reduced the risk of tumor growth by 60%. Another study found that patients taking enzalutamide lived longer without their cancer worsening compared to those on a different treatment. Additionally, enzalutamide significantly increased the time patients lived without the cancer spreading when used alone. Overall, these findings suggest that enzalutamide can effectively help manage prostate cancer that hasn't spread.13678
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
Men with nonmetastatic, castration-resistant prostate cancer can join this trial. They must be on hormone therapy or have had surgery to lower testosterone levels, have a rising PSA level with a doubling time of 10 months or less, and no signs of the cancer spreading. Participants should be relatively healthy overall, with an expected lifespan of at least one year.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive enzalutamide or placebo daily to assess safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Enzalutamide
- Placebo
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?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
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 LLC, a wholly owned subsidiary of Pfizer Inc.
Industry Sponsor