ENACT: Testing the Effectiveness of Enzalutamide in Delaying Progression of "Low Grade" Prostate Cancer

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Age:
Over 18 years of age
Gender:
Male
Healthy Volunteers:
No
Keywords:
prostate cancer, ENACT, Active surveillance, Enzalutamide, low grade prostate cancer
Type:
Open Label
Target:
5 Participants
Description
Prostate cancer is the most commonly diagnosed cancer, other than skin cancer, among men. Many men diagnosed with prostate cancer will be diagnosed with a localized disease. This means the cancer has not spread to the rest of the body. Typically, these are “low grade” prostate cancers.

For “low grade” prostate cancer instead of treatment an option is active surveillance. During active surveillance the prostate cancer is monitored by your doctor will looks for signs of progression. This is a viable option for those with “low grade” prostate cancer because of the significant risks and side effects involved in many of the available treatments.

Sometimes, prostate cancer that is being monitored progresses and treatment becomes necessary.

The purpose of this study is to see if an experimental medication “Enzalutamide” can slow the progression of early stage prostate cancer. Enzalutamide is an antiandrogen medication. Androgens, such as testosterone, participate in the growth of prostate cancer tumors. Thus, blocking androgens may result in less tumor growth.
This study requires
- Either active surveillance of prostate cancer or treatment with Enzalutamide (160mg) taken by mouth once a day for one year.

- Physical exams, various lab-work, digital rectal exams, analysis of urine, prostate biopsies, and questionnaires.
Who can participate?
- This study is open to male subjects, age 18 or older.

- We invite you to take part in this research study because you have early stage (localized) prostate cancer that was diagnosed within the past six months.

- You can only participate if you are currently undergoing active surveillance and no other treatment for your prostate cancer.
Benefits and risks of participating
Enzalutamide (160 mg) once daily is generally well tolerated. Risks and possible benefits will be discussed in details during the consent process.
Compensation
You will not be compensated for this study.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for at least two (2) years with the potential for up to 3 years depending upon when you are enrolled in this study.
Location
Urology clinic
4680 Y Street
suite 2200
Sacramento, CA 95817
Contact
Mark W Alger
916-703-9108 916-703-9108