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Steroidogenesis Inhibitor

Abiraterone Therapy for Metastatic Castration Resistant Prostate Cancer

Phase < 1

Waitlist Available

Led By Jingsong Zhang, M.D., Ph.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer (CRPC) patients on abiraterone with at least 50% decline of pre-treatment PSA

Prior surgical castration or concurrent use of gonadotropin-releasing hormone (GnRH) analogue with testosterone at screening <50 ng/dL

Must not have

Documented central nervous system (CNS) metastases or liver metastasis

Unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade > 2, New York Heart Association (NYHA) Class III or IV heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether an on and off schedule of taking abiraterone can prolong a cancer's response to the drug and help patients maintain their quality of life.

Who is the study for?

This trial is for men with metastatic castration-resistant prostate cancer who are minimally symptomatic and have seen a significant drop in PSA levels after standard abiraterone treatment. They should be able to perform daily activities, not require opioids for pain, and have no major health issues or recent surgeries.

What is being tested?

The study tests if taking abiraterone on an intermittent schedule can extend the drug's effectiveness in controlling prostate cancer while maintaining patients' ability to carry out everyday tasks.

What are the potential side effects?

Abiraterone may cause side effects like high blood pressure, heart problems, liver issues, digestive disturbances, difficulty swallowing tablets, and could potentially interfere with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is advanced but not causing major symptoms, and my PSA levels have dropped by at least 50% since starting abiraterone.

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I have undergone surgical castration or am using hormone therapy with low testosterone levels.

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I am able to get out of my bed or chair and move around.

Exclusion Criteria

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

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My cancer has spread to my brain or liver.

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I do not have severe heart problems like unstable angina, serious arrhythmias, or advanced heart failure.

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I do not have uncontrolled HIV, hepatitis B or C, or any serious illness that could affect my study participation.

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I don't have GI diseases or procedures that affect drug absorption.

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I stopped my prostate cancer treatments (except for bone treatments and hormone therapy) 3 weeks ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 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

Prostatic Specific Antigen (PSA) Response Rate

Secondary study objectives

Median Radiographic Progression-Free Survival (rPFS)

Median Time to Performance Status Deterioration

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 AST

elevated ALT

hematochezia

cough

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

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: Abiraterone Acetate TherapyExperimental Treatment1 Intervention

Study schedule involves stopping FDA Approved abiraterone after participants achieve a good PSA response (50% or more decline of pre-abiraterone PSA) and then restarting abiraterone after their PSA reaches the level of pre-abiraterone PSA.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abiraterone Acetate

2015

Completed Phase 4

~1880

0 / 8Eligibility criteria met