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Hormone Therapy

Abiraterone Acetate for Prostate Carcinoma

Phase 2

Waitlist Available

Led By Michael Schweizer

Research Sponsored by University of Washington

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from cycle 1, day 1 to the date of death, assessed up to 178 days

Awards & highlights

Study Summary

This trial is testing a new drug, erdafitinib, in combination with abiraterone acetate or enzalutamide, to see if it is more effective than either of those drugs alone in treating patients with double negative prostate cancer.

Eligible Conditions

Double-Negative Prostate Carcinoma
Prostate Cancer
Prostate Adenocarcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from cycle 1, day 1 to the date of death, assessed up to 178 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from cycle 1, day 1 to the date of death, assessed up to 178 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from cycle 1, day 1 to the date of death, assessed up to 178 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate

Secondary outcome measures

Incidence and Severity of Adverse Events (AEs)

Overall Survival (OS)

Prostate-specific Antigen (PSA) Response

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (abiraterone acetate, enzalutamide, erdafitinib)Experimental Treatment3 Interventions

Patients receive abiraterone acetate orally PO QD or enzalutamide PO QD on days 1-21. Patients also receive erdafitinib PO QD on days 1-21. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Erdafitinib

2017

Completed Phase 2

~150

Abiraterone Acetate

2015

Completed Phase 4

~1880

Enzalutamide

2014

Completed Phase 4

~2760

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,738 Previous Clinical Trials

1,844,348 Total Patients Enrolled

Janssen Research & Development, LLCIndustry Sponsor

975 Previous Clinical Trials

6,384,305 Total Patients Enrolled

Michael SchweizerPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

10 Previous Clinical Trials

141 Total Patients Enrolled

Frequently Asked Questions

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

When was Abiraterone Acetate approved by the FDA?

"There is some data supporting the safety of Abiraterone acetate, but none yet for efficacy. We rated it a 2."

Answered by AI

How many people total are included in the research?

"That is correct, the online information from clinicaltrials.gov affirms that this study is still recruiting patients. The original posting was on April 27th 2020 with the most recent update being October 25th 2022. They are hoping to recruit 25 total participants from a single location."

Answered by AI

Are there any other similar research projects to Abiraterone Acetate?

"As of now, 191 clinical trials are underway to study Abiraterone acetate. Out of those, 46 have reached Phase 3. Although a large portion of the clinical trials for this treatment take place in Germantown, Tennessee, there are 12839 total locations running these sorts of tests."

Answered by AI

Can people with the target illness join this clinical trial at present?

"The study is ongoing and recruiting patients, with the latest update having been on October 25th, 2020. This information can be found by looking at the clinicaltrials.gov website where the trial was originally posted on April 27th, 2020."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Erdafitinib and Abiraterone Acetate or Enzalutamide in Treating Patients With Double Negative Prostate Cancer

Michael Schweizer 2020. "Erdafitinib and Abiraterone Acetate or Enzalutamide in Treating Patients With Double Negative Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03999515.