Enzalutamide for Prostate Cancer

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

19 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase II trial compares enzalutamide with standard androgen deprivation therapy in reducing incidence of metabolic syndrome in patients with prostate cancer that has spread to other places in the body. Metabolic syndrome is defined as changes in cholesterol, blood pressure, circulating sugar levels, and body weight. Previous studies have shown that patients with prostate cancer, who have been treated with standard medical therapy that lowers testosterone levels, have an increased risk of these changes. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells instead of lowering testosterone levels. It is not yet known whether prostate cancer patients who receive enzalutamide will have reduced incidence of metabolic syndrome than patients who receive standard androgen deprivation therapy.

Research Team

Elizabeth R. Kessler

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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.

I am older than 18 years.

Must use a condom if having sex with a pregnant woman

Exclusion Criteria

Absolute neutrophil count < 1500/uL

Platelet count < 100,000/uL

Hemoglobin < 9 g/dL

Timeline

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)

Treatment Details

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.

Participant Groups

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+