Welcome to the KLK2-comPAS Study
A 2-part study for people with hormone-resistant prostate cancer that has spread to other parts of the body (metastasized).
Welcome to the KLK2-comPAS Study
A 2-part study for people with hormone-resistant prostate cancer that has spread to other parts of the body (metastasized).
The KLK2-comPAS Study is testing how safe and effective the investigational medication(s) is for people with hormone-resistant prostate cancer that has spread to other parts of the body (metastasized). Hormone-resistant prostate cancer means that the cancer is no longer responding to hormone therapy.
This study has 2 parts.
In Part 1 of this study, everyone who participates will be randomly assigned to receive the first investigational medication or the placebo.
In Part 2 of this study, everyone will be randomly assigned to receive either the 2 investigational medications, or just the first investigational medication, or the placebo.
A placebo looks like the investigational medication but has no active ingredients. In addition to the investigational medication(s) or the placebo, all study participants will receive supportive care, which helps treat and manage symptoms.
The goal of this study is to test how well one or both investigational medications work to stop or slow your cancer compared to the placebo.
Metastatic Hormone-Resistant Prostate Cancer (mHRPC) is an advanced stage of prostate cancer that has spread beyond the prostate gland to other parts of the body (metastatic). Prostate cancer cells often need a male hormone called testosterone to grow. Hormone-resistant prostate cancer means that the cancer cells have learned to grow even when the amount of testosterone in the body is very low.
Part 1
If you qualify for Part 1 of the study, you will be randomly assigned (like the flip of a coin) to get either the investigational medication (with supportive care) or a placebo (with supportive care).
Supportive care is the treatment and management of symptoms from your prostate cancer.
- There is a 2-in-3 (67%) chance of receiving the investigational medication, and a 1-in-3 (33%) chance of receiving the placebo.
- The investigational medication and the placebo are given by IV infusion over 30 to 60 minutes.
- This study is called “double-blind,” which means neither you nor the clinical staff will know if you are receiving the investigational medication or a placebo.
- You will receive the study treatment 3 times in the first cycle, and you will continue to receive 1 dose every 6-week cycle until the study treatment period ends.
Part 2
If you qualify for Part 2 of the study, you will be randomly assigned to get both investigational medications (with supportive care), or the first investigational medication (with supportive care),
or a placebo (with supportive care).
- There is a 1-in-3 (33%) chance of receiving both investigational medications, a 1-in-3 (33%) chance of receiving the first investigational medication, and a 1-in-3 (33%) chance of receiving the placebo.
- The first investigational medication and the placebo are given by IV infusion over 30 to 60 minutes. The second investigational medication is given by injection under the skin (subcutaneous).
- If you are assigned to receive both investigational medications, you and the clinical staff will know if you are receiving this treatment. This is called “open-label.”
- If you are assigned to 1 of the groups that receive either the investigational medication on its own or the placebo, then neither you nor the clinical staff will know which treatment you are receiving (this called "double-blind").
- You will receive your assigned study treatment 3 times in the first cycle, and you will continue to receive 1 dose every 6-week cycle until the study treatment ends.
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. This questionnaire is intended for United States participants only.
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