NCT03460977
Learn more about a clinical trial for the potential treatment of castration resistant prostate cancer.
Prostate cancer is one of the most common types of cancer. When the cancer is resistant to hormone therapy, it is called castration resistant prostate cancer (CRPC). It is considered metastatic when it has spread to other parts of the body.
This study is evaluating if an investigational (study) medicine is safe and effective in treating metastatic CRPC, and if it is effective in preventing further resistance to current standard-of-care medications for prostate cancer.
Who may participate
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
You will be asked to attend a visit at the study clinic 28 days after last treatment cycle
Some studies require the study team to stay in contact with the participant for a period of time after the participant completes the main part of the study. This long-term follow up is to collect additional information on the study drug over time.
About clinical trials
Clinical trials allow researchers to compare investigational medicines with current approved treatments. They help us understand if the possible benefits of a potential treatment option outweigh the risks.
Every modern medicine we have today was first tested in clinical trials. Thousands of volunteers around the world take part in clinical trials every year.
About clinical trials
Frequently Asked Questions
How long will I be in this study?
Your time in the clinical trial will vary depending on how many treatment cycles you complete. You will be able to continue taking the study medicine for as long as you and your doctor believe it is of benefit to you.
What are the possible benefits of participating?
This clinical trial may not provide any direct benefit to you. If you choose to participate, you will receive an investigational and/or standard-of-care medication that may improve your prostate cancer. Your prostate cancer and health will be monitored regularly throughout. Additionally, you will be contributing to research that will help us learn more about metastatic castration resistant prostate cancer and may help others with prostate cancer in the future.
What are the possible risks of participating?
All clinical trials have some risks. Your study doctor will discuss all the possible risks and benefits of participating with you before you choose to enroll. You can choose to no longer participate in the clinical trial at any time.
What if I change my mind about participating?
Your participation in this clinical trial is completely optional. You can choose to stop participating at any time, for any reason. Choosing not to participate in this clinical trial will not affect your future medical care or prostate cancer treatment.
How many appointments will I need to attend?
The number of required study visits will vary depending on the number of treatment cycles completed. In addition to the Screening visit, participants will need to attend at least three clinic visits per treatment cycle for the first five cycles, and two clinic visits for every cycle thereafter. Participants will also need to attend a follow-up visit about one month after completing their final treatment cycle.
What will happen at study visits?
What happens at each study visit will vary, but may include questions about your medical history, cancer diagnosis, and medications, physical exams, blood draws, biopsies (optional), electrocardiograms (ECGs), and CT/MRI/bone scans.
