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Antiandrogen

Abiraterone + Prednisone for Prostate Cancer (APRE Trial)

Phase 2
Recruiting
Led By Martha Mims, MD, PhD
Research Sponsored by Martha Mims
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients may have received prior surgery. For all major surgeries, at least 14 days must have elapsed since completion and patient must have recovered from all major side effects of surgery per investigator's assessment.
Patients may have received or plan to receive concurrent bone targeting agents that do not have an effect on PSA (e.g. denosumab or bisphosphonate).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment start until nadir, or up to 7 months after start of adt if no nadir
Awards & highlights

APRE Trial Summary

This trial will study how well standard prostate cancer treatments work in different ethnic groups.

Who is the study for?
Men with metastatic hormone naive prostate cancer who have not received certain prior treatments like ketoconazole or chemotherapy for metastasis. They must be over 18, have adequate organ function, and a Zubrod performance status of 0-2 (3 if due to bone pain). Prior surgery is okay after recovery, and they can't have severe heart issues or known brain metastases.Check my eligibility
What is being tested?
The study examines the effectiveness of standard care treatment with abiraterone acetate and prednisone in men with prostate cancer across different races/ethnicities. Participants will be followed for up to 10 years to see how well these treatments work.See study design
What are the potential side effects?
Abiraterone may cause high blood pressure, fluid retention, liver function changes, joint swelling/discomfort; Prednisone might lead to weight gain, mood swings, increased blood sugar levels among other potential side effects.

APRE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had surgery over 2 weeks ago and have recovered from major side effects.
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I am taking or plan to take bone-strengthening drugs that don't affect PSA levels.
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I had a full physical exam and discussed my medical history with a doctor within the last 28 days.
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I've had scans of my cancer within the last 42 days.
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I can take care of myself, but may not be able to do heavy physical work. If I'm less active, it's only because of bone pain.
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I started hormone therapy for prostate cancer less than 42 days ago and am willing to switch or continue treatment as required.
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I have advanced prostate cancer and cannot or will not undergo docetaxel treatment.
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I have prostate cancer that has spread, and I haven't started hormone therapy yet.
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My heart's electrical activity is normal as per my recent ECG.
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My kidney function is good, with a creatinine clearance rate of at least 40 mL/min.
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I am 18 years old or older.
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I have no cancer history, except for certain skin cancers, early-stage cancers in remission, or any cancer I've been free from for 5 years.
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I've had hormone therapy for cancer that didn't last over 36 months and it's been 6 months since my last treatment.
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My liver is functioning well according to recent tests.
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My blood tests meet the required levels for white blood cells, neutrophils, hemoglobin, and platelets.

APRE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment start until 7 months after start of adt
This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment start until 7 months after start of adt for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PSA Response Rate
Secondary outcome measures
Depth of PSA Response
Frequency of Potentially Deleterious Polymorphisms
Progression Free Survival
+3 more

APRE Trial Design

1Treatment groups
Experimental Treatment
Group I: Abiraterone acetate + prednisoneExperimental Treatment2 Interventions
All subjects will receive abiraterone acetate and prednisone, as per standard of care. Abiraterone acetate will be administered orally as 1000 mg once daily along with 5 mg of oral prednisone twice per day. Subjects will continue to take abiraterone acetate and prednisone until confirmed disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone Acetate
2015
Completed Phase 4
~1880
Prednisone
2014
Completed Phase 4
~2370

Find a Location

Who is running the clinical trial?

Martha MimsLead Sponsor
Martha Mims, MD, PhDPrincipal Investigator - Baylor College of Medicine
Ben Taub General Hospital, CHI St. Luke's Health-Baylor St. Luke's Medical Center, St Luke's Diagnostic Cath Lab LLP
Baylor College Of Medicine (Medical School)
Baylor College Of Medicine (Residency)

Media Library

Abiraterone Acetate (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT03833921 — Phase 2
Abiraterone Acetate (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03833921 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the usual indications for this therapy?

"This medical intervention is not only useful for treating thyroiditis, but can also be effective in combating ulcerative colitis, malignant neoplasms, and varicella-zoster virus acute retinal necrosis."

Answered by AI

Are there any open positions for volunteers in this clinical trial?

"That is correct. The clinicaltrials.gov website indicates that this trial, which was initially posted on May 23th 2019 and edited most recently on October 7th 2020, is currently recruiting patients. They are aiming to enroll 130 people from 3 different locations."

Answered by AI

How many people can enroll in this research project?

"Yes, the information on clinicaltrials.gov indicates that this trial is recruiting patients. The trial was initially posted on 5/23/2019 and was most recently edited on 10/7/2022. The study is looking for 130 participants at 3 locations."

Answered by AI

Is this a common treatment that has been well-researched?

"There are 378 total trials currently running that investigate this treatment, with 101 of those being in Phase 3. Duarte, California has the most studies for this treatment (n=?), but there are 17174 locations worldwide where these studies are taking place."

Answered by AI

Has this intervention received the FDA's green light?

"While Phase 2 trials don't have any data supporting efficacy, this treatment still received a score of 2 for safety."

Answered by AI
~14 spots leftby Nov 2024