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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

Must not have

Untreated symptomatic spinal cord compression

Baseline moderate and severe hepatic impairment (Child Pugh class B & C)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Approved for 50 Other Conditions

No Placebo-Only Group

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.

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.

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 below

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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.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have untreated spinal cord compression that causes symptoms.

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My liver is not working well (moderate to severe issues).

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I have a history of serious gut issues that could lead to a tear in my bowel.

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I have active or symptomatic viral hepatitis or chronic liver disease.

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My prostate cancer is of the small cell type.

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I haven't had cancer treatments in the last 5 years, except for skin or early bladder cancer.

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I have a digestive condition that affects how my body absorbs food.

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I have had serious heart issues or a heart attack in the last 6 months.

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My high blood pressure is not controlled, even with medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 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

Time on treatment

Secondary study objectives

Efficacy assessed

Expression of candidate markers

Incidence of adverse events

+2 more

Side effects data

From 2022 Phase 2 trial • 26 Patients • NCT03043807

81%

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

anxiety

xerosis

elevated ALT

hematochezia

cough

elevated AST

xerostomia

general body aches

pruritis

nail discoloration

fever

anemia

epistaxis

infusion related reaction

neutropenia

neutropenic fever

gastrointestinal reflux

pain (bilateral legs)

mucositis

pain (joint);

anorexia

nail ridging

weight gain

hematuria

urinary tract obstruction

oral candidiasis

insomnia

depression

dyspnea

arthritis

pain (pelvis)

memory impairment

heartburn

100%

80%

60%

40%

20%

Study treatment Arm

Chemohormonal and Definitive Therapy After Prostatectomy

Awards & Highlights

Approved for 50 Other Conditions

This treatment demonstrated efficacy for 50 other conditions.

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: 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

Abiraterone

FDA approved

Apalutamide

FDA approved

Cortisone

Not yet FDA approved

0 / 15Eligibility criteria met