This phase II trial studies the effect of erdafitinib in treating patients with prostate cancer that grows and continues to spread despite the surgical removal of the testes or drugs to block androgen production (castration-resistant). Erdafitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erdafitinib may help control disease in patients with castration-resistant prostate cancer. In addition, studying samples of blood, tissue, plasma, and bone marrow from patients with castration-resistant prostate cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.
PRIMARY OBJECTIVE: I. To evaluate efficacy of erdafitinib in subjects with advanced prostate cancer who have progressed on a second-generation androgen receptor (AR)-targeting agents (SART). SECONDARY OBJECTIVES: I. To evaluate the objective response rate II. To measure Time on Treatment (ToT) as a surrogate of clinical efficacy and Progression-Free Survival (PFS) III. To measure PFS. IV. To correlate bone specific alkaline phosphatase (BAP) modulation with response, ToT and PFS. V. To correlate prostate specific antigen (PSA) modulation with response, ToT and PFS. VI. To characterize the safety profile of subjects treated with erdafitinib. VII. To measure overall survival. VIII. To collect and archive bone marrow biopsies and aspirates, serum and plasma in study patients for later hypothesis generating associations. EXPLORATORY OBJECTIVE: I. To evaluate DNA, ribonucleic acid (RNA), or protein biomarkers in tissue and blood samples which potentially predict tumor response or resistance to erdafitinib. OUTLINE: Patients receive erdafitinib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may also undergo collection of blood and bone marrow via biopsy and aspirates. After completion of study treatment, patients are followed up at 30 days, every 16 weeks for 1 year, and then every 6 months thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Undergo biopsy
Undergo collection of blood and bone marrow
Given PO
M D Anderson Cancer Center
Houston, Texas, United States
Bone specific alkaline phosphatase (BAP) modulation
Will assess modulation of BAP under the influence of treatment. Calculated as the maximal percentage change (decrease versus increase) on treatment. BAP in blood samples will be used for the primary analysis. Proportion of patients with BAP reduction along with the 95% confidence interval (95% CI) will be estimated.
Time frame: Up to 5 years
Overall response rate
Defined as (a) the proportion of subjects with soft tissue disease who achieve complete response or partial response, as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 by the investigator and (b) the proportion of subjects with improvement in bone imaging as assessed by the principal investigator. Will be estimated with proportion and its corresponding 95% CI.
Time frame: Up to 5 years
Time on treatment
Measured as a surrogate of clinical efficacy and progression-free survival (PFS). Will be estimated using the method of Kaplan and Meier and the effects of potential.
Time frame: Duration in weeks/months from the time of treatment start until the patient goes off treatment for any reason, assessed up to 5 years
Progression-free survival
Will be estimated using the method of Kaplan and Meier and the effects of potential.
Time frame: Duration in weeks/months from the time of treatment start to the date of disease progression or death, whichever is reported first, assessed up to 5 years
Prostate specific antigen modulation
Calculated as the maximal percentage change (decrease versus increase) on treatment.
Time frame: Up to 5 years
Incidence of adverse events
Will be reported by their National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 term by grade and attribution.
Time frame: Up to 5 years
Overall survival
Will be estimated using the method of Kaplan and Meier and the effects of potential.
Time frame: Duration in weeks/months from the time of treatment start to the date of death, assessed up to 5 years
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