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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
Summary
This trial tests if erdafitinib combined with abiraterone acetate or enzalutamide can better treat double negative prostate cancer. Erdafitinib stops cancer cell growth, while the other drugs reduce or block testosterone use by the cancer cells. Abiraterone acetate and enzalutamide are commonly used in prostate cancer therapy, targeting the androgen receptor axis to improve patient outcomes.
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
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 moreTrial 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
Abiraterone Acetate
2015
Completed Phase 4
~1880
Enzalutamide
2014
Completed Phase 4
~2760
Erdafitinib
2017
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,762 Previous Clinical Trials
1,876,479 Total Patients Enrolled
Janssen Research & Development, LLCIndustry Sponsor
980 Previous Clinical Trials
6,384,290 Total Patients Enrolled
Michael SchweizerPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
10 Previous Clinical Trials
141 Total Patients Enrolled
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