11 Participants Needed

Erdafitinib for Castration-Resistant Prostate Cancer

Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
Must be taking: AR-targeting agents
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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 G. Corn | MD Anderson Cancer Center

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

You have a sufficient amount of a type of white blood cell called neutrophils.
Your AST or ALT levels in your blood are within a certain range.
Your bilirubin levels in the blood are within a certain range, unless you have a condition called Gilbert's disease.
See 16 more

Exclusion Criteria

I haven't been part of any drug trials or received experimental treatments in the last 30 days.
You have a current hepatitis B or C infection.
I am still experiencing side effects from previous cancer treatments.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

21 days per cycle, up to 5 years
Regular visits for treatment and monitoring

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.

Up to 5 years
Follow-up visits at specified intervals

Treatment Details

Interventions

  • Erdafitinib
Trial OverviewThe trial is testing Erdafitinib's effectiveness in treating advanced prostate cancer that resists standard treatment. It involves taking the drug orally and monitoring its impact on tumor growth by blocking enzymes needed for cell growth.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (erdafitinib, biospecimen collection)Experimental Treatment3 Interventions
Patients receive erdafitinib PO 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.

Erdafitinib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Balversa for:
  • Locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations
🇪🇺
Approved in European Union as Balversa for:
  • 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

Trials
3,107
Recruited
1,813,000+

Findings from Research

In a phase 2 study involving 51 men with castration-resistant prostate cancer (CRPC), gefitinib showed minimal clinical efficacy, with only 2% of patients achieving a significant reduction in prostate-specific antigen (PSA) levels.
The treatment was associated with notable side effects, leading to dose reductions in 13 patients and withdrawal in 9 due to adverse events, indicating that while some patients maintained stable performance status, the overall response to gefitinib was limited.
An open-label, single-arm phase two trial of gefitinib in patients with advanced or metastatic castration-resistant prostate cancer.Pezaro, C., Rosenthal, MA., Gurney, H., et al.[2018]
In a phase II study involving 30 patients with advanced prostate cancer, erlotinib showed moderate toxicity but resulted in clinical benefit for 40% of participants, indicating some effectiveness in improving patient outcomes.
While no patients experienced a decrease in prostate-specific antigen (PSA) levels, 14% had stabilization of PSA, and 10 patients showed a significant increase in PSA-doubling time, suggesting potential for further investigation in earlier stages of prostate cancer.
Results from a monocentric phase II trial of erlotinib in patients with metastatic prostate cancer.Gravis, G., Bladou, F., Salem, N., et al.[2020]
Erlotinib, an EGFR inhibitor, showed reduced effectiveness in treating castration-resistant prostate cancer, particularly when the EGFR/Her2 ratio was low, which was influenced by chronic treatment with bicalutamide.
The study suggests that erlotinib may be more effective in hormone-naive prostate cancer patients rather than those who have undergone hormonal treatment, as low levels of Her2 and a higher EGFR/Her2 ratio were associated with better drug efficacy.
Effects of EGFR tyrosine kinase inhibitor erlotinib in prostate cancer cells in vitro.Festuccia, C., Gravina, GL., Biordi, L., et al.[2018]

References

An open-label, single-arm phase two trial of gefitinib in patients with advanced or metastatic castration-resistant prostate cancer. [2018]
Additive antitumor effects of the epidermal growth factor receptor tyrosine kinase inhibitor, gefitinib (Iressa), and the nonsteroidal antiandrogen, bicalutamide (Casodex), in prostate cancer cells in vitro. [2018]
Results from a monocentric phase II trial of erlotinib in patients with metastatic prostate cancer. [2020]
Erlotinib has moderate single-agent activity in chemotherapy-naïve castration-resistant prostate cancer: final results of a phase II trial. [2018]
Effects of EGFR tyrosine kinase inhibitor erlotinib in prostate cancer cells in vitro. [2018]