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CDK4/6 Inhibitor

Abemaciclib + Hormone Therapy for Prostate Cancer (RAD 1805 Trial)

Phase 2
Waitlist Available
Led By Eddy Yang, MD, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have at least 1 target lesion
ECOG PS=0 or 1
Must not have
Known active viral or non-viral hepatitis or cirrhosis
Patients with active autoimmune disease and history of inflammatory bowel disease. Brachytherapy boost will not be permitted.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study if a new cancer drug is effective and safe when used with a hormone therapy to treat prostate cancer that has spread to nearby tissue or is at high risk of spreading.

Who is the study for?
Men with high-risk or advanced prostate cancer that hasn't spread, who haven't had systemic anti-cancer treatments. They must have a certain level of health, including normal organ function and blood counts, be able to perform daily activities with ease or some difficulty (ECOG PS=0 or 1), and agree to use contraception.
What is being tested?
The trial is testing the effectiveness and safety of abemaciclib pills taken twice daily in combination with standard hormone therapy for prostate cancer. Participants will also receive radiation therapy as part of their treatment.
What are the potential side effects?
Abemaciclib may cause diarrhea, fatigue, low white blood cell count which can lead to infection risk, liver problems like increased enzymes indicating damage or stress on the liver, deep vein thrombosis (blood clots), and possibly other side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least one measurable cancer lesion.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My prostate cancer is confirmed high-risk or advanced but not spread.
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My prostate cancer is aggressive based on its Gleason score and PSA levels.
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I have a biopsy sample from my tumor that can be tested.
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I have not received any systemic anti-cancer treatments before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have active hepatitis or cirrhosis.
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I have an active autoimmune disease or a history of inflammatory bowel disease, and I cannot receive brachytherapy boost.
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I have previously been treated with a CDK4-6 inhibitor.
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I do not have any severe health issues that could make this study unsafe for me.
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I have not had major surgery or significant injury in the last 4 weeks, or I have fully recovered from it.
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I do not have any active infections needing treatment or positive tests for Hepatitis B or C.
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I have a history of serious heart rhythm problems or sudden cardiac arrest.
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I have had treatments like chemotherapy or radiation for my cancer.
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I haven't had any major heart or stroke issues in the last 6 months.
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I am either surgically sterile or will use effective birth control during and for 6 months after the study.
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I have been diagnosed with an illness related to AIDS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical Response Rates
Secondary study objectives
PSA declines prior to radiotherapy
Time to PSA Failure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Abemaciclib + ADT+ RTExperimental Treatment3 Interventions
Abemaciclib at 150 mg by mouth twice daily, androgen deprivation therapy (ADT), and radiation therapy in conjunction with ADT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Androgen deprivation therapy (ADT)
2013
Completed Phase 4
~1310
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,343,033 Total Patients Enrolled
9 Trials studying Prostate Cancer
2,458 Patients Enrolled for Prostate Cancer
Eddy Yang, MD, PhDPrincipal Investigator - University of Alabama at Birmingham (UAB)
University of Alabama at Birmingham
Andrew McDonald, MDPrincipal InvestigatorUniversity of Alabama at Birmingham (UAB)
2 Previous Clinical Trials
288 Total Patients Enrolled

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04298983 — Phase 2
Prostate Cancer Research Study Groups: Abemaciclib + ADT+ RT
Prostate Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT04298983 — Phase 2
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04298983 — Phase 2
~1 spots leftby Apr 2025
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