Erdafitinib for Castration-Resistant Prostate Cancer
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it does mention that you should not have received any other investigational agent or participated in another clinical study within 30 days prior to starting this trial.
What makes the drug Erdafitinib unique for treating castration-resistant prostate cancer?
Erdafitinib is unique because it targets specific genetic changes in cancer cells, known as FGFR (fibroblast growth factor receptor) alterations, which are not typically addressed by standard prostate cancer treatments. This makes it a novel option for patients whose cancer has become resistant to traditional hormone therapies.12345
Research Team
Paul Corn
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
Men aged 18+ with castration-resistant prostate cancer and bone metastases are eligible. They must have had prior treatments like hormone therapy or chemotherapy, but not recent major surgery or radiation. Participants need to maintain low testosterone levels, have adequate organ function, be able to swallow pills, and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive erdafitinib orally once daily on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs at 30 days, every 16 weeks for 1 year, and then every 6 months thereafter.
Treatment Details
Interventions
- Erdafitinib
Erdafitinib is already approved in United States, European Union for the following indications:
- Locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations
- Locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor