Enzalutamide for Prostate Cancer

No longer recruiting at 1 trial location

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Colorado, Denver

Must not be taking: Corticosteroids, Antiandrogens, others

Disqualifiers: Metabolic syndrome, Hypogonadism, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether enzalutamide can reduce the risk of metabolic syndrome in prostate cancer patients whose cancer has spread. Metabolic syndrome includes high blood pressure, high cholesterol, high blood sugar, and weight gain. Standard prostate cancer treatments that lower testosterone levels can increase the risk of these issues. However, enzalutamide (also known as Xtandi) might help by blocking testosterone's effect on cancer cells instead. The trial seeks prostate cancer patients with advanced disease who are suitable for systemic treatment and do not already have metabolic syndrome. Participants will receive either enzalutamide or standard therapy to compare outcomes. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on androgen deprivation therapy or certain hormonal therapies, you must have stopped them at least 6 months before starting the trial.

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. In one study, it reduced the risk of death by 33% compared to those who did not take it, indicating that patients lived longer while using enzalutamide. Another study found that men taking enzalutamide had a 61% lower chance of their cancer worsening compared to those not taking the drug.

Previous patients have demonstrated good survival rates with enzalutamide. Specifically, men taking enzalutamide along with another drug had a 78.9% chance of surviving over eight years.

These studies suggest that enzalutamide is a safe option for many patients. However, individual experiences may vary, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Researchers are excited about enzalutamide for prostate cancer because it works differently than standard androgen deprivation therapies (ADT) like leuprolide acetate, goserelin acetate, and others. While these traditional treatments reduce testosterone levels to slow cancer growth, enzalutamide directly blocks the androgen receptors on cancer cells, preventing them from using any available testosterone. This unique mechanism can potentially offer a more targeted attack on cancer cells, potentially improving outcomes and reducing some side effects associated with hormone therapy.

What evidence suggests that enzalutamide might be an effective treatment for reducing metabolic syndrome in prostate cancer patients?

Research has shown that enzalutamide, which participants in this trial may receive, effectively treats prostate cancer. Studies have found that it helps patients live longer. For example, one study showed that enzalutamide lowered the risk of death by 33% compared to other treatments. It also helped patients live longer without their cancer worsening. These findings suggest that enzalutamide can be a strong option for managing prostate cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Elizabeth R. Kessler

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

Men over 18 with advanced prostate cancer that has spread or isn't suitable for primary therapy. They must have a life expectancy over 12 months, be able to consent, and use two forms of birth control if with a partner who can bear children. Excluded are those with low testosterone or PSA levels, certain blood counts or vitamin deficiencies, recent corticosteroid use, heart issues, seizures, brain metastasis, gastrointestinal disorders affecting drug absorption.

Inclusion Criteria

My prostate cancer diagnosis is confirmed by lab tests or my doctor's clinical data.

Must use a condom if having sex with a pregnant woman

I am older than 18 years.

Exclusion Criteria

Absolute neutrophil count < 1500/uL

Platelet count < 100,000/uL

Hemoglobin < 9 g/dL

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either enzalutamide or standard ADT for 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Degarelix
• Enzalutamide
• Goserelin Acetate
• Histrelin Acetate
• Leuprolide Acetate
• Triptorelin

Trial Overview The trial is testing whether enzalutamide reduces the risk of metabolic syndrome compared to standard hormone therapies in men with prostate cancer. Metabolic syndrome includes changes in cholesterol levels, blood pressure, sugar levels in the blood and body weight.

How Is the Trial Designed?

Group I: Arm I (enzalutamide) Experimental Treatment 1 Intervention

Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (ADT) Active Control 5 Interventions

Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT.

Degarelix is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Firmagon for:

• Advanced hormone-dependent prostate cancer

Approved in United States as Firmagon for:

• Advanced prostate cancer

Approved in Canada as Firmagon for:

• Hormone-sensitive prostate cancer

Approved in Japan as Firmagon for:

• Prostate cancer

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Citations

1. pfizer.com pfizer.com/news/press-release/press-release-detail/astellas-and-pfizers-xtanditm-enzalutamide-shows-long-term

Astellas and Pfizer's XTANDI™ (enzalutamide) Shows ... OS at 96 months was 50% with XTANDI and 40% for NSAA; progression-free survival (PFS) also favored XTANDI over NSAA (HR: 0.49; 95% CI, 0.42-0.57) ...

2. targetedonc.com targetedonc.com/shorts/a-13-year-old-drug-s-persisting-power-in-prostate-cancer

A 13-Year-Old Drug's Persisting Power in Prostate Cancer Two-year OS rates were 80% vs 63%. The treatment also yielded a record 57.1% pathological pCR. ... Clinical Trial Achieves 60% Reduction in the Risk of Tumor ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2510310?query=featured_home

Improved Survival with Enzalutamide in Biochemically ... In this trial, enzalutamide plus leuprolide led to significantly longer overall survival than leuprolide alone among patients with castration- ...

4. xtandihcp.com xtandihcp.com/cspc/efficacy

Efficacy CSPC | HCP Site | XTANDI® (enzalutamide) XTANDI (single agent) significantly improved metastasis-free survival vs placebo + GnRH therapy* · Number of events: 63 (17.7%) with XTANDI (single agent) vs 92 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40660075/

The efficacy and safety of enzalutamide in metastatic ... Results: The data of 2275 patients were analyzed eventually. Enzalutamide reduced the risk of death by 33% compared to the control. Specifically ...

6. pfizer.com pfizer.com/news/press-release/press-release-detail/xtandir-plus-leuprolide-reduced-risk-death-40-vs-leuprolide

XTANDI® Plus Leuprolide Reduced Risk of Death by 40% ... The probability of survival at 8 years was an unprecedented 78.9% with XTANDI plus leuprolide versus 69.5% with leuprolide, in men with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12504157/

Comparative effectiveness and safety of enzalutamide ... Enzalutamide use was associated with superior overall survival (hazard ratio 0.88, 95% confidence interval [CI] 0.82–0.96) compared with ...

8. xtandi.com xtandi.com/clinical-trials

Clinical Trial Results | XTANDI® (enzalutamide) Men taking XTANDI had a 61% lower chance of their cancer progressing compared with men not taking XTANDI during the study. Progression was seen in 89 men (15.5 ...