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CDK4/6 Inhibitor
Abemaciclib + Hormone Therapy for Prostate Cancer (RAD 1805 Trial)
Phase 2
Waitlist Available
Led By Andrew McDonald, MD
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 months
Awards & highlights
RAD 1805 Trial 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.Check my eligibility
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.See study design
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.
RAD 1805 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
RAD 1805 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Response Rates
Secondary outcome measures
PSA declines prior to radiotherapy
Time to PSA Failure
RAD 1805 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
Radiation Therapy
2017
Completed Phase 3
~7250
Androgen deprivation therapy (ADT)
2013
Completed Phase 4
~1310
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,581 Previous Clinical Trials
2,278,020 Total Patients Enrolled
10 Trials studying Prostate Cancer
2,738 Patients Enrolled for Prostate Cancer
Andrew McDonald, MDPrincipal InvestigatorUniversity of Alabama at Birmingham (UAB)
2 Previous Clinical Trials
294 Total Patients Enrolled
Eddy Yang, MD, PhDPrincipal Investigator - University of Alabama at Birmingham (UAB)
University of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active hepatitis or cirrhosis.I have an active autoimmune disease or a history of inflammatory bowel disease, and I cannot receive brachytherapy boost.I have a cancer other than prostate cancer that doesn't need further treatment.I have previously been treated with a CDK4-6 inhibitor.I have at least one measurable cancer lesion.I do not have any severe health issues that could make this study unsafe for me.I have not had major surgery or significant injury in the last 4 weeks, or I have fully recovered from it.I am fully active or restricted in physically strenuous activity but can do light work.My prostate cancer is confirmed high-risk or advanced but not spread.My prostate cancer is aggressive based on its Gleason score and PSA levels.I have a biopsy sample from my tumor that can be tested.I do not have any active infections needing treatment or positive tests for Hepatitis B or C.I have a history of serious heart rhythm problems or sudden cardiac arrest.I have not received any systemic anti-cancer treatments before.I have had treatments like chemotherapy or radiation for my cancer.I haven't had any major heart or stroke issues in the last 6 months.I am either surgically sterile or will use effective birth control during and for 6 months after the study.I have been diagnosed with an illness related to AIDS.
Research Study Groups:
This trial has the following groups:- Group 1: Abemaciclib + ADT+ RT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are allowed to be part of this research project?
"Indeed, the clinical trial is currently recruiting patients. The study was first posted on February 25th, 2021 and updated most recently on March 18th, 2022. They are seeking to enroll 30 individuals at a single site."
Answered by AI
What are some common reasons why people might choose to go through Radiation Therapy?
"Although radiation therapy is commonly used as a preventative measure for high-risk patients, it can also treat other conditions like advanced hr + her2 - breast cancer and endocrine therapy."
Answered by AI
To your knowledge, is this the first time a clinical trial like this has been conducted?
"Radiation Therapy has been under clinical investigation since 2009 when it was first trialled by Eli Lilly and Company. The Phase 1 approval for the therapy followed the successful initial study in 2009 which had 220 participants. Now, there are 97 active trials involving Radiation Therapy being conducted across 1276 cities and 41 countries."
Answered by AI
Are we enrolling test subjects for this research project at the moment?
"That is correct, the information available on clinicaltrials.gov indicates that this trial is still looking for patients to enroll. The study was initially posted on February 25th 2021 and was last updated March 18th 2022. They are hoping to enroll 30 patients from 1 site."
Answered by AI
Has the FDA cleared radiation therapy as a treatment?
"While Phase 2 trials have not yet yielded data supporting efficacy, there is some evidence to suggest that radiation therapy is safe. As such, our team at Power has rated it a 2."
Answered by AI
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