Antiandrogen

Abiraterone acetate + prednisone for Prostate Cancer

Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX

Targeting 2 different conditionsAbiraterone Acetate +1 morePhase 2RecruitingLed by Martha Mims, MD, PhDResearch 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 or plan to receive concurrent bone targeting agents that do not have an effect on PSA (e.g. denosumab or bisphosphonate).

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Uptreatment start until nadir, or up to 7 months after start of adt if no nadir

Awards & highlights

All Individual Drugs Already Approved

Approved for 30 Other Conditions

No Placebo-Only Group

Study Summary

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

Eligible Conditions

Prostate Cancer

Eligibility Criteria

Inclusion Criteria

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

Select...

You are allowed to take bone-targeting medications like denosumab or bisphosphonates, as long as they don't affect your PSA levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ treatment start until 7 months after start of adt

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 30 Other Conditions

This treatment demonstrated efficacy for 30 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: 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

FDA approved

Prednisone

FDA approved

0 / 1Eligibility criteria met

Find a site

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