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Antiandrogen
Abiraterone + Prednisone + Apalutamide for Prostate Cancer
Phase 2
Waitlist Available
Led By Paul Corn
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study Summary
This trial studies how well abiraterone acetate, prednisone, and apalutamide work in treating patients with hormone-naive prostate cancer.
Who is the study for?
Men with hormone-naive metastatic prostate cancer who can perform daily activities with some limitations (ECOG <=2) and have certain high-risk factors like a Gleason score >=8. They must not have small cell prostate cancer, heart issues, or conditions increasing bowel perforation risk. Participants need to be able to take oral medication and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the combination of abiraterone acetate, prednisone, and apalutamide in treating men whose prostate cancer has spread but haven't had hormonal treatments yet. The goal is to see if these drugs can reduce the body's production of hormones that fuel tumor growth.See study design
What are the potential side effects?
Possible side effects include fatigue, liver function changes, joint swelling/pain, hot flushes, headache, high blood pressure, diarrhea, vomiting and indigestion. There may also be an increased risk of infections due to lowered immune system function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I stopped taking any medication that could increase my risk of seizures 4 weeks ago.
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I can take care of myself but might not be able to do heavy physical work.
Select...
My hemoglobin level is at least 9.0 g/dL without transfusions or medications in the last 3 months.
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My prostate cancer is high-risk with at least 2 of these: Gleason score >= 8, 3+ bone lesions, or significant spread to organs.
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I can swallow pills whole.
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My prostate cancer was confirmed by a lab test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time on treatment
Secondary outcome measures
Efficacy assessed
Expression of candidate markers
Incidence of adverse events
+2 moreSide effects data
From 2022 Phase 2 trial • 26 Patients • NCT0304380781%
fatigue
38%
hot flashes
38%
neuropathy
19%
alopecia;
19%
dysgeusia
15%
hiccups
15%
nausea
15%
skin alterations
12%
diarrhea
12%
gastritis
12%
edema (lower extremity)
12%
rash
12%
constipation
8%
anxiety
8%
xerosis
4%
hematochezia
4%
elevated ALT
4%
xerostomia
4%
cough
4%
elevated AST
4%
general body aches
4%
pruritis
4%
nail discoloration
4%
fever
4%
anemia
4%
epistaxis
4%
infusion related reaction
4%
neutropenia
4%
neutropenic fever
4%
gastrointestinal reflux
4%
pain (bilateral legs)
4%
mucositis
4%
pain (joint);
4%
anorexia
4%
nail ridging
4%
weight gain
4%
hematuria
4%
urinary tract obstruction
4%
oral candidiasis
4%
insomnia
4%
depression
4%
dyspnea
4%
arthritis
4%
pain (pelvis)
4%
memory impairment
4%
heartburn
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemohormonal and Definitive Therapy After Prostatectomy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (abiraterone acetate, prednisone, apalutamide)Experimental Treatment3 Interventions
Patient receive abiraterone acetate PO daily, prednisone PO BID, and apalutamide PO daily. Cycles repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apalutamide
FDA approved
Abiraterone
FDA approved
Cortisone
Not yet FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,721 Total Patients Enrolled
96 Trials studying Prostate Cancer
29,740 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,263 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
Paul CornPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
181 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My platelet count is at least 100,000 without transfusions in the last 3 months.I have had limited treatment for my metastatic prostate cancer before starting this trial.I stopped taking any medication that could increase my risk of seizures 4 weeks ago.I have untreated spinal cord compression that causes symptoms.I do not have an active infection or a condition that prevents steroid use. I do not have HIV/AIDS.My liver is not working well (moderate to severe issues).I have a history of serious gut issues that could lead to a tear in my bowel.I can take care of myself but might not be able to do heavy physical work.My hemoglobin level is at least 9.0 g/dL without transfusions or medications in the last 3 months.My prostate cancer is high-risk with at least 2 of these: Gleason score >= 8, 3+ bone lesions, or significant spread to organs.I take more than 10 mg of prednisone daily for a chronic condition.I have active or symptomatic viral hepatitis or chronic liver disease.My prostate cancer is of the small cell type.I haven't had cancer treatments in the last 5 years, except for skin or early bladder cancer.I have a digestive condition that affects how my body absorbs food.I can swallow pills whole.My prostate cancer was confirmed by a lab test.I have had serious heart issues or a heart attack in the last 6 months.My high blood pressure is not controlled, even with medication.My liver function tests are within the required range.I have a condition or history that increases my risk of seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (abiraterone acetate, prednisone, apalutamide)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 50 Other Conditions - This treatment demonstrated efficacy for 50 other conditions.
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 participants are partaking in this research experiment?
"As of now, this particular trial is not in recruitment mode. It was initially announced on July 22nd 2019 and the most recent update occurred August 26th 2022. If you are seeking alternative trials, there are currently 3679 studies searching for participants with malignant neoplasm of prostate and 460 clinical investigations recruiting patients related to Abiraterone acetate."
Answered by AI
Has Abiraterone Acetate gained clearance from the FDA?
"As this is currently a Phase 2 study, there are no conclusions on efficacy; however, the safety of Abiraterone acetate has been validated with available data and therefore receives an overall score of 2."
Answered by AI
To what extent has Abiraterone Acetate been explored in previous research?
"Presently, there are 460 active clinical trials for Abiraterone acetate with 129 of those in the advanced Phase 3. While many studies are taking place at Duarte, California, an impressive 19,852 sites across the globe have been evaluating this compound."
Answered by AI
Can more individuals still join this research endeavor?
"The trial's information on clinicaltrials.gov reveals that it is no longer recruiting participants, with the original posting date being July 22nd 2019 and its last update occurring August 26th 2022. Nevertheless, there are over 4100 other studies currently looking for volunteers to take part in them."
Answered by AI
For which medical conditions is Abiraterone Acetate commonly prescribed?
"Abiraterone acetate has been found to provide relief from scalp structure issues, thyroiditis, and the early stages of prostate cancer."
Answered by AI
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