Active not recruitingPHASE2, PHASE3INTERVENTIONAL

A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer

This clinical trial is designed to investigate a new treatment approach for men with prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone therapy. The study is comparing a combination of medicines: abiraterone acetate and prednisone, with or without an additional drug called abemaciclib. Researchers want to understand if adding abemaciclib can improve how well the treatment works and if it is safe for patients. This is a crucial step in finding better ways to manage advanced prostate cancer, offering hope for improved outcomes for those living with the condition.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

393

Start

26 Nov 2018

Estimated completion

01 Jun 2026

Prostate Cancer

Results

Results from this study

Posted March 2025

Results have been published for this study.

Primary outcome

Radiographic Progression Free Survival (rPFS)

The rPFS time is measured from the date of randomization to the earliest date of investigator determined radiographic disease progression (by objective radiographic disease assessment per response evaluation criteria in solid tumors (RECIST) version 1.1 for soft tissue AND/OR radionuclide bone scan using prostate cancer working group 3 -PCWG3 criteria for bone) or death from any cause, whichever occurs first.

Full results on the registry

What is this study about?

When you have prostate cancer that has spread and isn't responding to hormone therapy anymore, it's called metastatic castration-resistant prostate cancer. Doctors are always looking for better ways to treat this type of cancer. This study is testing a new combination of medicines to see if it can help.

The main medicines being looked at are abiraterone acetate and prednisone, which are already used to treat prostate cancer. The researchers are adding a new medicine called abemaciclib to this combination. Abemaciclib works in a different way to try and slow down cancer growth.

By comparing patients who receive abiraterone and prednisone with those who also receive abemaciclib, the study aims to understand if the new triple combination is more effective or if it causes more side effects. The results of this study could help doctors decide on the best treatment options for men with advanced prostate cancer in the future.

Key takeaways

Tests a new combination treatment for advanced prostate cancer.
Compares current treatment with an added new drug (abemaciclib).
Aims to find safer and more effective ways to treat prostate cancer.
Participation involves regular clinic visits and monitoring.
You can leave the study at any time.

Who may be eligible?

To join this study, you must be a man with prostate cancer that has been confirmed by a biopsy. Your cancer needs to have spread to other parts of your body, which doctors will check with bone scans or MRI scans. The cancer also needs to have shown signs of getting worse while you were on hormone treatment or after surgery.

You should be in generally good health, meaning your body organs are working well, and you can carry out most of your normal daily activities without much trouble. You cannot have had certain other cancer treatments in the past, such as specific types of chemotherapy or similar drugs to abemaciclib.

There are also some health conditions that would prevent you from taking part, like serious heart or liver problems, or issues that would stop you from taking pills. The study will make sure you meet all the necessary health and treatment history requirements to ensure it's safe for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I been diagnosed with prostate cancer that has spread?
Is my prostate cancer no longer responding to hormone treatment?
Am I generally in good health?
Do I take pills easily, and do I not have severe heart or liver problems?
Have I avoided certain previous treatments for my prostate cancer?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given study medication, which you will likely take as pills. You will have regular visits to the clinic for check-ups, where doctors will monitor your health, perform blood tests, and scan your body to see how the treatment is working. This will involve appointments over a period of time, and the research team will explain the full schedule to you.

The total duration of your participation will depend on how you respond to the treatment and the study design, but generally, these types of studies involve consistent monitoring for several months or even longer. After you stop taking the study medication, there will likely be follow-up appointments to track your long-term health.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as access to a new treatment combination that isn't widely available yet, which could be more effective for your cancer. However, there are also potential risks, including side effects from the medications, which will be carefully monitored by the study team. You will be given detailed information about these side effects before you decide to join. It's very important to remember that participating is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (112)

St. Joseph's Hospital and Medical Center
Verified postcode
Phoenix, United States
Mayo Clinic in Arizona - Phoenix
Verified postcode
Phoenix, United States
The University of Arizona Cancer Center - North Campus
Verified postcode
Tucson, United States
St. Bernards Medical Center
Verified postcode
Jonesboro, United States
CBCC Global Research, Inc.
Verified postcode
Bakersfield, United States
Providence St. Jude Medical Center
Verified postcode
Fullerton, United States
Moores Cancer Center
Verified postcode
La Jolla, United States
TRIO-US (Translational Research in Oncology-US)
Verified postcode
Los Angeles, United States
UCLA Hematology/Oncology - Westwood (Building 100)
Verified postcode
Los Angeles, United States
Pacific Cancer Care
Verified postcode
Monterey, United States
Sansum Clinic_Kendle
Verified postcode
Santa Barbara, United States
Rocky Mountain Cancer Center
Verified postcode
Lone Tree, United States

Common questions

What is metastatic castration-resistant prostate cancer?

This is a type of prostate cancer that has spread outside the prostate gland and is no longer being controlled by standard hormone treatments.

What are abiraterone acetate and prednisone?

These are medicines that doctors already use to treat prostate cancer. Abiraterone helps reduce male hormones that fuel cancer, and prednisone is a steroid often given with it to manage side effects.

What is abemaciclib and how does it work?

Abemaciclib is a new medicine being tested. It works by blocking certain proteins (CDK4 and CDK6) that can help cancer cells grow and divide.

Will I know if I'm getting the new drug or the placebo?

This is a 'blinded' study, meaning neither you nor your doctor will know if you are receiving abemaciclib or a dummy pill (placebo) alongside abiraterone and prednisone. This helps ensure unbiased results.

How long will I be in the study?

The length of your participation can vary, but generally, you will be closely monitored while you are receiving the study medication and for a period afterwards. The study team will explain the expected timeline.