RecruitingPHASE2INTERVENTIONAL

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

This study is for men with prostate cancer who have been taking enzalutamide in a previous research study and are still benefiting from it. The main goal is to collect more details about the long-term safety of enzalutamide. If you join, you will continue with the same enzalutamide treatment and other medicines you were taking in the earlier study. You'll have regular appointments, usually every six months, to check on your health and any side effects. This helps researchers understand how safe enzalutamide is over an extended period for patients who are doing well on the treatment. It's a way to keep track of patients who are already seeing positive effects from the medication.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Astellas Pharma Global Development, Inc.

Enrolment target

900

Start

22 Dec 2016

Estimated completion

31 Jul 2029

Prostate Cancer

What is this study about?

This study is designed for men who have prostate cancer and are currently taking a medication called enzalutamide as part of another research study. Importantly, to be considered for this new study, you must have been benefiting from enzalutamide in that previous study, meaning it was helping to control your cancer. The main reason for this new study is to gather more information about how safe enzalutamide is when used for a longer time, especially for those patients who are finding it effective.

Think of it as continuing to monitor patients who are already doing well on a certain treatment within a research setting. The pharmaceutical companies Astellas or Medivation, who make enzalutamide, are sponsoring this research. By collecting long-term safety information, they can better understand the full picture of the drug's effects over extended periods.

So, if enzalutamide is working for you and you were in one of their previous studies, this new study offers a way to continue receiving the treatment under careful medical supervision while contributing important information that could help many other patients in the future.

Key takeaways

This study is for men with prostate cancer already benefiting from enzalutamide in an earlier study.
The main goal is to collect more data on the long-term safety of enzalutamide.
Participants will continue their current enzalutamide treatment and other medicines.
Regular clinic visits will be scheduled, usually every six months, to monitor health and side effects.
All side effects, new or old, will be carefully tracked.

Who may be eligible?

To be considered for this study, you must be a man with prostate cancer who is already taking enzalutamide in an earlier research study sponsored by Astellas or Medivation, and your doctor believes you are still benefiting from the treatment. You also need to be able to continue with the same treatment plan you had in the previous study, though small changes might be made with the study doctor's approval.

It's important that you can swallow the enzalutamide capsules and are able to follow all the study's instructions. If you have a female partner who could become pregnant, you both must agree to use two types of birth control throughout the study and for three months afterwards. You also cannot donate sperm during this time or join any other experimental treatment studies.

Quick self-check

I am a man with prostate cancer.
I am currently taking enzalutamide in a research study sponsored by Astellas or Medivation.
My doctors believe the enzalutamide is still helping my cancer.
I am able to continue with my current treatment plan.
I am willing and able to attend regular clinic appointments.
My partner and I will use effective birth control if applicable.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll continue taking enzalutamide and any other medications exactly as you were in your previous study. You'll typically have appointments at the clinic every 24 weeks (about every six months) to check on your health and discuss any side effects. There might also be shorter visits every 12 weeks to collect used medication and give you more if needed. These visits are important for monitoring your safety and how you're responding to treatment.

Any new side effects, or existing ones, will be carefully recorded from the moment you agree to take part until the study finishes. The study will continue for as long as you are benefiting from the treatment and wish to participate. You can decide to leave the study at any time.

Potential risks and benefits

The potential benefits of joining this study include continuing to receive enzalutamide if it's currently helping to control your prostate cancer, all while under careful medical supervision. This may provide ongoing access to treatment that is working for you. As with any medication, there are potential risks, and any side effects you experience will be closely monitored by the study team. They will also record any new side effects or serious health issues that come up. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (241)

Site US10052
Anchorage, United States· Completed
Site US10011
Tucson, United States· Completed
Site US10040
Los Angeles, United States· Completed
Site US10009
Los Angeles, United States· Completed
Site US10067
Orange, United States· Recruiting
Site US10008
San Bernardino, United States· Completed
Site US10042
San Diego, United States· Completed
Site US10028
Stanford, United States· Completed
Site US10001
Aurora, United States· Completed
Site US10017
Denver, United States· Completed
Site US10050
Washington D.C., United States· Completed
Site US10049
Daytona Beach, United States· Completed

+229 more sites — see the official record for the full list.

Common questions

What is enzalutamide?

Enzalutamide is a medication used to treat prostate cancer. It works by blocking certain hormones that can make prostate cancer grow.

Why is this study only for men who were in a previous study?

This study is designed to gather more information about the long-term safety of enzalutamide in patients who have already shown they are benefiting from it in an earlier research study.

Will my treatment change in this study?

Generally, you will continue with the same enzalutamide dose and other treatments you were receiving in your previous study. Minor changes may be made with the study doctor's approval if medically necessary.

How often will I need to visit the clinic?

You will typically have full check-up visits about every 24 weeks (roughly every six months), with shorter visits every 12 weeks to manage your medication.

What happens if I experience side effects?

Any side effects, new or ongoing, will be carefully recorded and managed by the study team during your regular visits.

How to find out more

Astellas Pharma Global Development

astellas.registration@astellas.com 800-888-7704 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.