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

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

No Placebo-Only Group

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate

Secondary study objectives

Incidence and Severity of Adverse Events (AEs)

Overall Survival (OS)

Prostate-specific Antigen (PSA) Response

+2 more

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: 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

~3820