Welcome to the KLK2-comPAS Study
A study for people with hormone-resistant prostate cancer that has spread to other parts of the body (metastasized).
In order to qualify for the study, you’ll go through a screening process that may include blood tests, a CT or MRI of your tumor, and a physical exam.
You or your loved one can join the study if:
- You are 18 years of age or older
- You have biopsy-confirmed adenocarcinoma of the prostate that is hormone-resistant that has spread to other parts of your body (metastasized)
- Your PSA level is equal to or higher than 2 ng/mL at screening
- You have had prior treatment with an androgen receptor pathway inhibitor (like Zytiga, Erleada, or Xtandi) and chemotherapy (such as docetaxel or cabazitaxel)
- You have had prior testicle removal surgery, or you are receiving testosterone-lowering treatment (such as ongoing ADT)
There are other requirements to participate. The clinical staff will give you more information.
You or your loved one cannot join the study if:
- You have had an organ or bone marrow transplant
- You have an autoimmune disease (where your immune system attacks your body) and are taking medications to suppress your immune system
- You need significant oxygen support (more than 2 liters per minute through a nasal cannula) to breathe
- You have another cancer, other than prostate cancer, that might interfere with the study results
- You have had serious heart or stroke problems in the last 6 months
There are other requirements to participate. The clinical staff will give you more information.
Screening Visit: During the screening period, you will have tests and procedures, including imaging/scans, to see if you qualify for the study. The study doctor will answer any questions you may have and ask you to sign an informed consent form (ICF).
Treatment Phase: If you qualify, you will be randomly assigned to get either the study drug (with supportive care) or a placebo (with supportive care). Both are given by IV infusion over 30 to 60 minutes. Neither you nor the clinical staff will know if you are receiving the study drug or the placebo.
The study schedule is broken out into groups that repeat, called a cycle. The first cycle is 8 weeks and all other cycles are 6 weeks.
You may experience some side effects during or after the IV infusion. To help minimize the side effects, the study doctor may give you some medication (premedication) within 2 hours before your IV infusion.
Follow-up Period: Follow-up visits every 12 weeks may be done at the clinic or on the phone. Follow-up visits help us collect useful information about the study drug.
Clinical research studies may help to find better ways to treat different conditions. When people from all backgrounds participate in clinical research, it helps us understand how medicines affect people around the world who are impacted by certain conditions and diseases. Your participation may help shape the future of cancer care.
See if you may qualify
Answer the following questions to see if you or someone you know may be eligible to take part in this study.
Please keep in mind:
Even if you believe you meet the eligibility criteria, joining a clinical trial is not guaranteed. Whether you’re referred or able to take part depends on a review by a qualified healthcare professional.
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About your information:
With your consent, we will use your answers to help determine whether you may be eligible for this clinical trial. You can withdraw your consent at any time.
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