Study on Trametinib for Treating Advanced Hormone-Resistant Prostate Cancer
Sponsor: Jonsson Comprehensive Cancer Center
ClinicalTrials ID:NCT02881242
This clinical trial is testing how well the drug trametinib works in patients with prostate cancer that no longer responds to hormone therapy and has spread to other parts of the body. Trametinib may help stop cancer growth by blocking certain enzymes needed for cell growth.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the effectiveness of trametinib in treating prostate cancer that has become resistant to hormone therapy and has spread. The study will look at how long the drug can keep the cancer from getting worse, how it affects PSA levels, and its impact on quality of life. Researchers will also monitor how long it takes before patients need to start a different cancer treatment, how long it takes for the cancer to show up on scans again, and overall survival rates. The safety and side effects of trametinib will also be assessed. Patients will take trametinib by mouth once a day as long as it is effective and does not cause unacceptable side effects. After finishing the treatment, patients will have follow-up visits at 2 and 4 weeks, and then every 4 weeks.
Description
This study aims to see how well trametinib works for patients with advanced prostate cancer that no longer responds to hormone therapy. The main goal is to see if trametinib can help control the cancer in patients who have already tried other treatments like enzalutamide or abiraterone acetate. Researchers will measure how long it takes for PSA levels to rise again, the maximum reduction in PSA levels, and the overall quality of life of participants. They will also track how long it takes before patients need to switch to another cancer treatment, how long it takes for the cancer to progress on scans, and the overall survival time from when patients join the study. Safety and side effects will be closely monitored. The study will also explore how trametinib interacts with specific proteins in cancer cells and look for genetic markers that might predict how well patients respond to the treatment. Patients will take trametinib orally once a day, and treatment will continue as long as it is effective and tolerable. After completing the treatment, patients will have follow-up visits at 2 and 4 weeks, and then every 4 weeks.
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide informed consent.
- Have a confirmed diagnosis of prostate cancer.
- Have advanced prostate cancer that has worsened despite previous treatments, including abiraterone acetate and/or enzalutamide.
- Have a metastatic tumor that has been biopsied.
- Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
- Willing to undergo a biopsy of a metastatic tumor if the cancer progresses.
- Continue therapy to keep testosterone levels below 50 ng/dL.
- Have adequate blood cell counts and organ function, including:
- Neutrophil count above 1,500/uL.
- Platelet count above 100,000/uL.
- Hemoglobin level above 9 g/dL.
- Normal liver and kidney function tests.
- Heart's pumping ability at or above 45%.
- Normal EKG results.
Exclusion Criteria
- History of certain eye conditions like retinal vein occlusion or retinal pigment epithelial detachment.
- Significant heart disease, including recent heart attacks or heart failure.
- Abnormal EKG results or history of serious heart rhythm problems.
- Have a pacemaker or defibrillator.
- Have other serious medical conditions that could interfere with the study.
- History of lung disease or inflammation.
- Use of certain medications or supplements that affect prostate cancer or PSA levels.
- Previous use of trametinib or similar drugs.
- Known or suspected brain metastasis or spinal cord compression.
- Digestive disorders affecting absorption.
- Recent major surgery, radiation, or chemotherapy.
- Recent hospitalization for cancer-related events.
- History of another cancer within the past 5 years, except for certain skin cancers.
- Use of investigational drugs within 4 weeks.
- Use of medications affecting androgen levels.
- Any condition that, in the investigator's opinion, could interfere with the study or pose a risk to the patient.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | 90095 | Los Angeles | California |
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