Erdafitinib and Abiraterone Acetate or Enzalutamide in Treating Patients With Double Negative Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03999515|
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : April 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Castration-Resistant Prostate Carcinoma Double-Negative Prostate Carcinoma Metastatic Prostate Carcinoma Prostate Adenocarcinoma Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8||Drug: Abiraterone Acetate Drug: Enzalutamide Drug: Erdafitinib||Phase 2|
OUTLINE: Patients receive abiraterone acetate orally (PO) once daily (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.
After completion of study treatment, patients are followed up at 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Erdafitinib Plus Abiraterone Acetate or Enzalutamide in Double Negative Prostate Cancer|
|Actual Study Start Date :||April 27, 2020|
|Estimated Primary Completion Date :||March 12, 2022|
|Estimated Study Completion Date :||March 12, 2022|
Experimental: Treatment (abiraterone acetate, enzalutamide, erdafitinib)
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.
Drug: Abiraterone Acetate
- Objective response rate [ Time Frame: Up to 2 years ]Will be calculated as the percentage of patients, with 95% confidence intervals, achieving a complete response or partial response across the entire study population at any time.
- Radiographic progression free survival (PFS) [ Time Frame: Up to 2 years ]Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue metastases and Prostate Cancer Working Group 3 criteria for bone metastases. Will be presented with Kaplan-Meier curves, and the median survival with 95% confidence interval (CI) will be calculated. Rates will be reported as percentages with 95% CI.
- Time to response [ Time Frame: Up to 2 years ]Will be assessed by RECIST 1.1.
- Overall survival (OS) [ Time Frame: From cycle 1, day 1 to the date of death, assessed up to 2 years ]Will be assessed by RECIST 1.1. Will be presented with Kaplan-Meier curves, and the median survival with 95% CI will be calculated. Rates will be reported as percentages with 95% CI.
- Prostate-specific antigen (PSA) response [ Time Frame: Baseline up to 2 years ]PSA response will be defined by a > 50% reduction in PSA compared with baseline at any point during treatment.
- Incidence and severity of adverse events (AEs) [ Time Frame: Within 14 days of end of treatment ]Will be assessed using version National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will characterize AEs by type and grade. Safety will be summarized as the severity and frequency of a given AE.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03999515
|Contact: Zoya Bauer||(206)firstname.lastname@example.org|
|Contact: Michael Schweizer||(206)email@example.com|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Zoya Bauer 206-606-7486 firstname.lastname@example.org|
|Principal Investigator: Michael Schweizer|
|Principal Investigator:||Michael Schweizer||Fred Hutch/University of Washington Cancer Consortium|