Active not recruitingPHASE3INTERVENTIONAL

A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)

This study is for men with prostate cancer that has spread to other parts of the body and is still responding to hormone treatments. Researchers want to find out if adding a new drug, abemaciclib, to the standard treatment (abiraterone plus prednisone) can help keep the cancer from getting worse for a longer time. The study will compare men receiving the new drug combination to men receiving the standard treatment plus a dummy pill. We hope to learn if this new combination could be a more effective way to manage this type of prostate cancer. Your participation could last about five years.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

925

Start

14 Apr 2022

Estimated completion

01 Oct 2027

Prostatic Neoplasms Neoplasm Metastasis Urogenital Neoplasms Physiological Effects of Drugs Antineoplastic Agents Antineoplastic Agents, Hormonal Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Abiraterone Acetate Steroid Synthesis Inhibitors Cytochrome P-450 Enzyme Inhibitors Prednisone Prednisolone Cyclin-Dependent Kinase 4 Cyclin-Dependent Kinase 6

What is this study about?

This study is for men who have prostate cancer that has spread to other parts of the body, like the bones or other organs. This type of cancer is called 'metastatic.' Importantly, this study is for cancer that is still responding well to hormone-blocking treatments, which is often the first type of treatment doctors use.

The main goal of this research is to see if adding an experimental drug called abemaciclib to the usual treatment of abiraterone and prednisone can make a difference. We want to know if this combination can hold the cancer back and stop it from growing or spreading further for a longer period of time. By finding new and better ways to treat advanced prostate cancer, doctors hope to improve the lives of those affected.

This is a 'Phase 3' study, which means it's one of the final steps before a new treatment might become widely available. It's a large study where we compare the new treatment combination against the standard treatment to see which one works better and is safer. Everyone in the study will receive excellent medical care.

Key takeaways

This study is for men with advanced prostate cancer that is responding to hormone treatment.
It aims to see if a new drug, abemaciclib, improves standard treatment.
Participation involves taking tablets and having regular check-ups and scans.
The study could last around five years.
You will receive close medical care throughout the study.

Who may be eligible?

This study is looking for men whose prostate cancer has spread to other areas of the body, such as at least four bone spots, or at least one spot in organs like the lungs or liver. You must have already started hormone treatment for your prostate cancer, and your cancer should still be responding to it. You'll also need to be generally well enough to take part in a clinical study.

There are also some reasons why you wouldn't be able to join. For example, if you've already had certain newer treatments for metastatic prostate cancer like abemaciclib or similar drugs, or if your metastatic prostate cancer developed while your testosterone levels were already very low due to previous treatments. You also can't have certain heart conditions or severe liver disease, and any brain tumours that have spread would need to have been treated and stable for a while.

Quick self-check

Do I have prostate cancer that has spread to other parts of my body?
Is my prostate cancer still responding to hormone treatments?
Have I already started hormone treatment for my prostate cancer?
Am I generally well enough for a clinical study?
Have I had certain newer treatments for advanced prostate cancer (like abemaciclib or similar drugs)? (If yes, you may not be eligible)
Do I have certain serious heart or liver conditions, or untreated brain tumours that have spread? (If yes, you may not be eligible)

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

What does participation involve?

If you decide to join this study, you will take either the new study drug (abemaciclib) or a dummy pill (placebo), along with your regular abiraterone and prednisone. These drugs are usually taken as tablets. You'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. The study team will explain exactly what's involved in each visit.

Your participation in the study could last for about five years (60 months). This includes the time you'll be taking the treatment and also a follow-up period to see how you're doing long-term. You'll have close medical supervision throughout the entire study.

Potential risks and benefits

Taking part in this study could potentially benefit you by offering an experimental treatment that might keep your cancer from getting worse for longer than standard treatment alone. However, there's no guarantee it will work for everyone, and it's also possible you could be in the group receiving the dummy pill alongside standard care. All medications have potential side effects, and the study doctor will explain all known risks of abemaciclib and the other drugs. You will be closely monitored for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (266)

Arizona Oncology Associates, P.C. - HOPE
Prescott, United States
Arizona Oncology Associates, P.C. - HOPE
Prescott Valley, United States
The University of Arizona Cancer Center - North Campus
Tucson, United States
Genesis Cancer and Blood Institute
Hot Springs, United States
St. Bernards Medical Center
Jonesboro, United States
Highlands Oncology Group
Springdale, United States
Orange Coast Memorial Medical Center
Fountain Valley, United States
Providence Medical Foundation
Fullerton, United States
Moores Cancer Center
La Jolla, United States
MemorialCare Health System - Long Beach Medical Center
Long Beach, United States
Cancer and Blood Specialty Clinic
Los Alamitos, United States
UCLA Hematology/Oncology - Santa Monica
Los Angeles, United States

+254 more sites — see the official record for the full list.

Common questions

What is 'hormone-sensitive' prostate cancer?

This means your prostate cancer is still responding to treatments that lower male hormones, like testosterone, which can fuel cancer growth.

What is abemaciclib?

Abemaciclib is a new drug being tested. It works differently from hormone treatments, aiming to slow down cancer cell growth.

Why is a 'dummy pill' used in the study?

A dummy pill (placebo) helps researchers fairly compare the new drug's effects against standard treatment. This way, we can be sure any improvements are due to the study drug.

How long will I be in the study?

Your involvement in the study, including treatment and follow-up, could last for about five years.

Will I still receive my usual prostate cancer care?

Yes, everyone in the study will receive standard medical care for their prostate cancer, along with the study treatment.