Study on Erdafitinib for Treating Castration-Resistant Prostate Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04754425

Provider View

This clinical trial is testing the drug erdafitinib to see if it can help control prostate cancer that continues to grow despite treatments that lower testosterone levels. The study also involves collecting blood and tissue samples to learn more about the cancer's DNA changes.

Patient Parameters

Program Overview

This study is exploring whether erdafitinib can help stop the growth of prostate cancer that keeps spreading even after treatments to lower testosterone levels, such as surgery or medication. Erdafitinib works by blocking certain enzymes that cancer cells need to grow. Researchers will also collect blood, tissue, and bone marrow samples from participants to study DNA changes and identify cancer-related markers.

Description

The main goal of this study is to see how effective erdafitinib is for patients with advanced prostate cancer that has not responded to other treatments targeting androgen receptors. Researchers will also look at how long patients stay on treatment, how long they live without the cancer getting worse, and overall survival rates. They will monitor changes in specific proteins and markers in the blood to see how they relate to the treatment's effectiveness.

Participants will take erdafitinib by mouth once a day for 21 days in a cycle that repeats every 21 days, as long as the cancer does not progress or side effects are manageable. Blood and bone marrow samples will be collected for further study.

After finishing the treatment, participants will have follow-up visits 30 days later, every 16 weeks for a year, and then every 6 months.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of prostate cancer with evidence of spread to the bones or other areas, as shown by scans.
  • Have low testosterone levels due to previous treatments.
  • Show signs of cancer progression, such as rising PSA levels or new lesions on scans.
  • Have previously been treated with certain androgen receptor-targeting drugs.
  • May have received prior immunotherapy or bone-targeting treatments.
  • Can have had chemotherapy before, but no more than two different types, and must have finished at least 3 weeks before starting this study.
  • Meet specific blood count and organ function requirements.
  • Able to swallow pills.
  • Agree to provide tissue and blood samples for research.
  • Men with partners who can become pregnant must use two forms of birth control and not donate sperm during the study and for 3 months after.

Exclusion Criteria

  • Recent radiation therapy within 2 weeks before starting the study.
  • Participation in another clinical trial within 30 days before starting this study.
  • Other cancers requiring treatment within the past year, except for certain skin cancers.
  • Uncontrolled high blood pressure.
  • Eye conditions that increase the risk of eye problems.
  • Serious medical or psychiatric conditions that could interfere with the study.
  • Recent severe heart problems or blood clots.
  • Active HIV or hepatitis infections, unless well-controlled.
  • Not fully recovered from side effects of previous cancer treatments.
  • Recent major surgery within 4 weeks before starting the study.
  • Untreated spinal cord compression causing symptoms.

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